Comparison between Tazarotene 0.05% gel and Adapelene 0.1% gel in acne patients

Sharwari Jaiswal; Sugat Jawade

doi:10.12688/f1000research.139034.1

Home Browse Comparison between Tazarotene 0.05% gel and Adapelene 0.1% gel in...

ALL Metrics

-

Views

-

Downloads

Get PDF

Get XML

Export

▬

✚

Study Protocol

Comparison between Tazarotene 0.05% gel and Adapelene 0.1% gel in acne patients

[version 1; peer review: 1 approved, 1 approved with reservations]

Sharwari Jaiswal ¹, Sugat Jawade¹

PUBLISHED 15 Nov 2023

Author details Author details

¹ Department of dermatology, venereology, and leprosy, Jawaharlal Nehru Medical College, Wardha, Maharashtra, 442005, India

Sharwari Jaiswal
Roles: Conceptualization, Supervision, Validation

Sugat Jawade
Roles: Conceptualization, Project Administration, Supervision, Validation, Visualization

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Background: Acne is an extremely common skin condition, which has a major social and psychological impact on young patients. Retinoids have been a mainstay of anti-acne therapy. Older generation agents are slowly replaced by newer generation ones like tazarotene and adapalene as they exhibit lower toxicologic risk and less side effects and they effectively reduce the comedones and inflammatory lesions. This study throws light on effectiveness of topical Adapalene gel- 0.1% and Tazarotene gel-0.05% in order to find out a suitable option with lesser side effects for acne patients.

Methods: After clearance from the institutional ethics committee, acne patients aged >12-35 years at the outpatient area of the Dermatology department, AVBRH, Jawaharlal Nehru Medical College, Sawangi, Wardha, were enrolled in the study. Patients will be randomly assigned in two groups wherein group A will be prescribed Tazarotene-0.05% gel and group B prescribed Adapalene-0.1% gel along with Tab Azithromycin-500mg thrice weekly for 12 weeks for both groups. Patients will be clinically assessed on every 4th, 8th and 12th week. Global acne score system will be applied at enrolment and at each subsequent follow-up for evaluation.

Keywords

Acne vulgaris tazarotene , adapelene

Corresponding author: Sharwari Jaiswal

Competing interests: No competing interests were disclosed.

Grant information: The author(s) declared that no grants were involved in supporting this work.

Copyright: © 2023 Jaiswal S and Jawade S. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Jaiswal S and Jawade S. Comparison between Tazarotene 0.05% gel and Adapelene 0.1% gel in acne patients [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2023, 12:1472 (https://doi.org/10.12688/f1000research.139034.1) First published: 15 Nov 2023, 12:1472 (https://doi.org/10.12688/f1000research.139034.1) Latest published: 15 Nov 2023, 12:1472 (https://doi.org/10.12688/f1000research.139034.1)

Introduction

The development of papules which are erythematous pustules and sometimes nodules and pseudocysts all often occur in acne patients.¹ More than 85% of teenagers are affected, making it a very common skin disorder in younger population.² The main pathogenic mechanisms include propionibacterium acnes microbiological colonisation of pilosebaceous units, which promotes perifollicular inflammation, oil gland secretion stimulation by androgens, abnormal infundibular epithelial keratinization, and hyperkeratinization.³ When it comes to ultrastructure, it can be shown that follicular keratinocytes in comedones contain more desmosomes and tonofilaments. A pilo-sebaceous follicular disorder with persistent inflammation that can affect young adults and has negative social and psychological outcomes. Regardless of colour or ethnicity, everyone between the ages of 12 and 17 must have occasionally come into contact with a white head or a black head. Therefore, it is therefore crucial to manage acne at the earliest possible stage.⁴

Since they have so many different mechanisms of action, retinoids have been a crucial part of anti-acne therapy. They successfully lessen the inflammatory lesions and comedones. Newer generation medications like Tazarotene and Adapalene are gradually replacing the long-established Tretinoin and Isotretinoin. These are selective for a subset of retinoic acid receptors, also unlike Tretinoin, that exhibits lower toxicologic risk and results in less side effects.⁵ This study focuses primarily on the effectiveness of Adapalene gel of 0.1% applied topically and Tazarotene gel of 0.05% applied topically in order to find a modality of treatment for facial acne vulgaris that is more effective because very few clinical trials based on the basis of effectivity and toleranace of tazarotene gel of 0.05% to that of adapelene gel of 0.1% have been performed.

Rationale

One of the skin conditions that causes emotional trauma, feelings of inferiority, and insecurity, acne is one of the skin conditions that today’s teenagers worry about the most. Consequently, it is now important to manage acne at an early stage.³

A retinoic acid receptor-specific drug is tazarotene. It inhibits keratinocyte growth, differentiation, and markers of inflammation. The drug also increases the expression of three distinct genes called TIG-1, TIG-2, and TIG-3 are the three genes that may have an antiproliferative effect. Instead of an indirect effect linked to the improvement of disease, the result of tazarotene on these indicators is likely an influence on expression of genes.⁶ Retinoids are frequently used as a last resort to cure acne, but they also have a few negative effects. Finding a retinoid with fewer side effects is therefore necessary and preferred. Additionally, relatively few research has been done in India regarding the effectiveness of 0.05% tazarotene. Therefore, it is crucial to create a study that focuses on comapritive study between these two. Also this study will help us infer to which topical formulations are effective for acne treatment wherein oral medication need not be given or are contraindicated.

Aims and objectives

The aim of this study is the comparison of the effectivity of tazarotene gel of 0.05% to that of adapelene gel of 0.1% in treating acne vulgaris on the face.

The objectives are as follows:

1) To research how well topical Tazarotene 0.05% gel works to treat acne vulgaris on the face.
2) To research the effectiveness tazarotene gel of 0.05% to that of adapelene gel of 0.1%.
3) To evaluate how well Adapalene gel of 0.1% and topical Tazarotene gel of 0.05% treat acne on the face.
4) To investigate the multiple adverse effects of tazarotene gel of 0.05% and adapalene gel of 0.1%.

Methods

Study design

The study will be a randomized, single blinded, parallel group, case controlled trial. Patients suffering from acne vulgaris patients with age >12-35 years attending the the outpatient unit of the Department of Dermatology, AVBRH Sawangi Meghe, Wardha. The study period is two years; from June 2022 to September 2024.

Sample size

Prevalance of acne in group of following age of 12-35 years is a range of 75-80%

Prevalance of acne vulgaris in an age group of 12-35 years is a range of 75-80%

With value of significance 0.05

A 80.27% reduction in acne vulgaris lesions was shown with the usage of 0.1% adapelene.

B 53.13% reduction in acne vulgaris lesions was shown with the usage of 0.1% tazorotene.⁷

nA = {k^{n}}_{B} and n_{B} - (p A (1 - p A) / k + p B (1 - p B)) (z 1 - ɑ + z 1 - β / 2 / {(│ p_{A} - p_{B} │ - §)}^{2})

pA	Anticipated response rate with standard treatment	0.8
PB	Anticipated response rate with new treatment	0.53
Α	Set level of Type-1 Error (Usual Value 0.05)	0.05
Β	Set level of Type-2 Error (Usual value 0.2)	0.2
D	Absolute difference in Ps and Pn	0.27
Δ	Set level of equivalence	0.05
Z1-α	Z associated with α	1.644854
Z1-β/2	Z associated with selected β	1.281552
K	Sampling Ratio nA/nB (Usual values 1-3)	1
N	Here, K = 1, so nA = nB (By Method-1, Method-2)	73

Sample size in each group: 73

Total sample size: 146

Inclusion criteria

1) Patients irrespective of gender.
2) Patients with age >12–35 years.
3) Patients willing to participate.
4) Patients with acne grade (based on Global Acne Scoring Criteria): I, II, III.

Exclusion criteria

1. History of hypersensitivity or allergic reactions to retinoids.
2. Patients with a history of photosensitivity.
3. Females who are pregnant, lactating mothers and married women planning for pregnancy.
4. Patient with photo aggravated disorders.

Methods

Patients who have been clinically diagnosed with acne vulgaris with age >12-35 years who would be registered from June 2022 to September 2024 at the OPD of department of Dermatology, JNMC Wardha, Sawangi Wardha with clearance from the institutional ethics committee (ECR/440/Inst/MH/2013/RR-2019). All patients who choose to participate voluntarily will be asked for written informed consent. a thorough background containing information on your age, gender, educational level, socioeconomic standing, employment, marital status, occupation, past drug use, and the length of the application will be taken.

Patients will be randomized into one of two groups (Group A and Group B) by straight forward randomization by computer-generated numbers. Group A will be prescribed Tazarotene 0.05% gel along with Tab Azee 500 mg thrice weekly for 12 weeks and Group B will be prescribed Adapalene 0.1% gel along with Tab Azee 500 mg thrice weekly.

For assessment of improvement a system of scoring will be called Global Acne Scoring (Table 1) be used when the patient is being enrolled and also with every consecutive follow-up.⁸

Table 1. Global acne scoring criteria.

Location	Grade
Forehead	2
Right cheek	2
Left cheek	2
Nose	1
Chin	1
Chest & upper back	3

Global acne scores:

0 = NONE

1-18 = MILD

19-30 = MODERATE

31-38 = SEVERE

>39 = VERY SEVERE

Total counts of papules, comedones, nodules, pustules, at the time of the first visit and then in every consecutive follow-up will be noted down. It will also be mentioned that retinoids have negative effects, including dryness, erythema, acne flare-ups, and itching. The method application that will be explained to the patient will include the application of tazarotene on the acne lesions overnight on a properly washed clean face. A routine moisturizer will be prescribed to a patient to combat the dryness that may be a side effect.

The study will have a total 12 weeks (3 months) follow-up duration. The patient will be called for follow-up every fortnight during this tenure.

Outcome measure

Total clearance of lesions, improvement in numbers of counts of comedones, papules, pustules, and nodules, improvement in global acne scoring, side effects i.e. dryness, erythema, itching, and flare-up of acne will be studied. To observe the improvement in the acne of patients based on Global Acne Scoring systems, keeping a note of the decrease in the number of counts of lesions with every follow-up visit or clearance of lesions, subjective patient improvement scoring, and the side effects that arise with the usage of 0.05% tazarotene and 0.1% adapalene.

Statistics

For our statistical analysis, we will apply the necessary parametric and non-parametric tests. The SPSS 16.0 version will be used to analyse the data collected. For the comparison of qualitative data between two variables, descriptive statistics like proportion, mean, and standard deviation will be employed, while the chi square test and other statistics that are inferential like chi square test will be employed. Using independent T tests (unpaired t tests) and paired t tests, quantitative data between two variables will be compared before and after. The 95% level will act as the fixed upper bound for significance if the p-value is less than 0.05.

Scope

1. To add newer topical drugs for reating patients of facial acne.
2. To study the effect of tazarotene with other systemic drugs in combinations.
3. To study the effect of tazarotene with combinations with other topical agents.

Study status

The study is ongoing.

Discussion

A study determined that tazarotene 0.1% cream and tretinoin 0.05% cream are individually effective and tolerable in the treatment of mild to moderate acne vulgaris. Patients were alloted in a group of two, Group A and Group B, based on the number of comedones.⁹

Bershad et al. determined that Tazarotene shows improvement patients of acne vulgaris when used topically. A safe and efficient topical treatment for acne appears to be topical tazarotene with the exception of ovulating females, in whom proper safety precautions should be taken.¹⁰

Acne on face was treated with tazarotene gel of 01% and adapelene gel of 0.1%. in a study in 106 acne patients. Every patient had a thorough clinical examination. The efficiency of daily use of tazarotene gel of 0.05% and adapalene gel of 0.1% for the treatment of facial acne vulgaris were evaluated in a multicenter, double-blind, randomised comparison research.¹¹

GF Webster and colleagues found that the treatment with tazarotene gel has been associated with considerably higher rates of success when compared to adapalene as well as significantly lower levels of total disease severity, lesion count of non inflammatory type and inflammatory type. In conclusion, tazarotene gel of 0.1% was more effective than adapalene gel of 0.1% and was also a more cost-effective treatment.¹² Our findings will be in line with the said research.

Conclusion

This is a randomised controlled study wherein we compare the efficacy of 0.05% tazarotene gel to 0.1% adapelene gel in grade I to III patients with acne vulgaris. This study’s significance lies in the addition of newer topical medications and the examination of the interaction between tazarotene and other systemic medications. Also to study the effect of tazarotene with combinations with other topical agents that will help us find better effective modality for patient of acne on the face.

Data availability

No data are associated with this article.

References

1. Layton AM: Disorders of the Sebaceous Glands.Burns T, Breathnach S, Cox N, et al., editors. Rook’s Textbook of Dermatology. 8th ed.Oxford: Wiley-Blackwell Scientific Publications; 2010; p 42.17. Publisher Full Text
2. James WD: Clinical practice. Acne. N. Engl. J. Med. 2005; 352: 1463–1472. Publisher Full Text
3. Toyoda M, Morohashi M: Pathogenesis of acne. Med. Electron Microsc. 2001 Mar; 34(1): 29–40. Publisher Full Text
4. Aktans OE, Sanli B: Anxiety, Depression and Nature of Acne vulgaris in Adolescents. Int. J. Dermatol. 2000; 39: 354–357. PubMed Abstract | Publisher Full Text
5. Smithard A, Glazebrook C, Williams HC: Acne prevalence, knowledge about acne and psychological morbidity in midadolescence: a community – m based study. Br. J. Dermatol. 2001; 145: 274–279. PubMed Abstract | Publisher Full Text
6. Duvic M, Nagpal S, Asano AT, et al.: Molecular mechanisms of tazarotene action in psoriasis. J. Am. Acad. Dermatol. 1997 Aug 1; 37(2): S18–S24. PubMed Abstract | Publisher Full Text
7. Anjum K, Altaf F, Shahzadi N, et al.: Comparison of Efficacy of 0.1% Tazarotene Versus 0.1% Adapalene for the Treatment of Mild Acne Vulgaris. Pak. J. Med. Health Sci.2020; 14(1): 63–66.
8. Doshi A, Zaheer A, Stiller MJ: A comparison of current acne grading systems and proposal of a novel system. Int. J. Dermatol. 1997 Jun; 36(6): 416–418. PubMed Abstract | Publisher Full Text
9. Rahman MH, Sikder MS, Khondker L: Efficacy and tolerability of 0.1% tazarotene cream and 0.05% tretinoin cream in the treatment of acne vulgaris. Bangabandhu Sheikh Mujib Med. Univ. J. 2015; 8(1): 24–29. Publisher Full Text
10. Bershad S, Singer GK, Parente JE, et al.: Successful treatment of acne vulgaris using a new method: results of a randomized vehicle-controlled trial of short-contact therapy with 0.1% tazarotene gel. Arch. Dermatol. 2002 Apr 1; 138(4): 481–489. PubMed Abstract | Publisher Full Text
11. Noor N, Paracha MM, Kamal K, et al.: Comparison of the efficacy of tazarotene 0.1% gel with adapalene 0.1% gel in the treatment of facial acne vulgaris. J. Postgrad. Med. Inst. 2021 Apr 1; 35(2).
12. Webster GF, Guenther L, Poulin YP, et al.: A multicenter, double-blind, randomized comparison study of the efficacy and tolerability of once-daily tazarotene 0.1% gel and adapalene 0.1% gel for the treatment of facial acne vulgaris. Cutis. 2002 Feb 1; 69(2 Suppl): 4–11. PubMed Abstract

Comments on this article Comments (0)

Version 1

VERSION 1 PUBLISHED 15 Nov 2023

Author details Author details

¹ Department of dermatology, venereology, and leprosy, Jawaharlal Nehru Medical College, Wardha, Maharashtra, 442005, India

Sharwari Jaiswal
Roles: Conceptualization, Supervision, Validation

Sugat Jawade
Roles: Conceptualization, Project Administration, Supervision, Validation, Visualization

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Article Versions (1)

version 1

Published: 15 Nov 2023, 12:1472

https://doi.org/10.12688/f1000research.139034.1

Copyright

© 2023 Jaiswal S and Jawade S. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Download

Export To

metrics

	Views	Downloads
F1000Research	-	-
PubMed Central Data from PMC are received and updated monthly.	-	-

Citations

0

SEE MORE DETAILS

CITE

how to cite this article

Jaiswal S and Jawade S. Comparison between Tazarotene 0.05% gel and Adapelene 0.1% gel in acne patients [version 1; peer review: 1 approved, 1 approved with reservations]. F1000Research 2023, 12:1472 (https://doi.org/10.12688/f1000research.139034.1)

NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.

track

receive updates on this article

Track an article to receive email alerts on any updates to this article.

Open Peer Review

Version 1

VERSION 1

PUBLISHED 15 Nov 2023

Views

1

Reviewer Report 25 May 2024

PRASETYADI MAWARDI, Sebelas Maret University, Surakarta, Indonesia

Approved

https://doi.org/10.5256/f1000research.152274.r240342

This study opens new horizons in the use of vitamin A acid derivatives, Tazarotene and adapalene in the management of Acne Vulgaris (AV). In various references, these two topical drugs are said to have fewer side effects than tretinoin. However, ... Continue reading

This study opens new horizons in the use of vitamin A acid derivatives, Tazarotene and adapalene in the management of Acne Vulgaris (AV). In various references, these two topical drugs are said to have fewer side effects than tretinoin. However, the effectiveness of both in the treatment of AV has not been widely studied.

Authors must provide in-depth arguments about:

Why are all degrees of acne vulgaris used as research subjects, whether classified as mild, moderate and severe AV?
Why does mild AV also receive Azithromycin 500mg trice a week therapy, receiving the same treatment as moderate AV and severe AV?
How do we minimize confounding factors, do moderate AV and severe AV show improvement due to topical administration of Tazarotene or Adapalene compared to the effect of Azithromycin 500mg trice a week, in overcoming the inflammatory process or due to Cutibacterium acnes infection?
How do the authors assess the role of Psychoneuroimmunological or Psychodermatological factors that are closely related to moderate and severe AV in groups of adolescent children?

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Clinical dermatology, Cosmetic dermatology, Skin cancer, Skin Surgery, Sexually Transmitted Infection

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

CITE

Report a concern

Respond or Comment

Views

1

Reviewer Report 06 Mar 2024

Isabel Cristina Valente Duarte de Sousa, Hospital ABC Campus Santa Fe, Mexico City, Mexico

Approved with Reservations

https://doi.org/10.5256/f1000research.152274.r250095

"General comments
Please revise the text for proper English grammar, since there are many mistakes throughout the text
The study design is not clear. Were the retinoids applied all over the face or just over active acne lesions?
... Continue reading

"General comments
Please revise the text for proper English grammar, since there are many mistakes throughout the text
The study design is not clear. Were the retinoids applied all over the face or just over active acne lesions?

Specific comments:
Introduction
1. Papules are not the same as erythematous pustules. Papules have a solid interior while pustules have a liquid one.
2. You missed the most important type of acne lesion, the one that precedes all others: the comedone
3. About the pathogenic mechanisms involved in the appearance of acne lesions: the abnormal infundibular keratinization leads to hyperkeratinization.
4. why is it important to mention that keratinocytes in comedones have more desmosomes or monofilaments?
5. The sentence "A pilosebaceous follicular disorder....." is incomplete. Perhaps it should read: Acne is a pilosebaceous follicular disorder.....
6. The sentence "Regardless of color and ethnicity, everyone between the ages of 12 and 17 must have occasionally....." sounds like speculation
7. The sentence "Therefore, it is therefore...." is repetitive and doesn't convey why early treatment of acne is important. Do you mean that the treatment of acne is crucial to manage early because many patients experience it? Perhaps it could be better explained that treatment of acne is important because regardless of severity it impacts the patient's quality of life.
8. "Since they have so many different mechanism of action, retinoids...." could be better stated as: retinoids act on most of the pathogenic mechanisms involved in the appearance of acne lesions.
9. " These are selective for a subset of retinoic acid receptors, also unlike Tretinoin, that exhibits lower toxicologic risk and results in less side effects" this is badly stated and perhaps should read: These are selective for a subset of retinoic acid receptors, that unlike Tretinoin, exhibit lower toxicologic risk and results in less side effects
10. "This study focuses primarily on the effectiveness of Adapalene gel of 0.1% applied topically and Tazarotene gel of 0.05% applied topically in order to find a modality of treatment for facial acne vulgaris that is more effective because very few clinical trials based on the basis of effectivity and toleranace of tazarotene gel of 0.05% to that of adapelene gel of 0.1% have been performed." This sentence is confusing and needs revision. Do you mean that the aim of this study is to compare the effectiveness and safety of Adapalene versus tazarotene?

Rationale
1. "One of the skin conditions that causes emotional trauma, feelings of inferiority, and insecurity, acne is one of the skin conditions that today’s teenagers worry about the most. Consequently, it is now important to manage acne at an early stage." Please revise the English in this sentence. Perhaps it should read: Acne is one of the skin conditions that today's teenagers worry about the most as it causes emotional trauma, feelings of inferiority and insecurity.
2. "The drug also increases the expression of three distinct genes called TIG-1, TIG-2, and TIG-3 are the three genes that may have an antiproliferative effect." should be corrected to: The drug also increases the expression of three distinct genes called TIG-1, TIG-2, and TIG-3 which are genes that may have an antiproliferative effect.
3. "Instead of an indirect effect linked to the improvement of disease, the result of tazarotene on these indicators is likely an influence on expression of genes". Please revise this sentence, as it does not convey a clear message.
4. "Retinoids are frequently used as a last resort to cure acne, but they also have a few negative effects." This statement is not true at all. Retinoids are the mainstay of current acne therapy. Please check current treatment guidelines by the AAD and EADV
5. "Therefore, it is crucial to create a study that focuses on comapritive study between these two. Also this study will help us infer to which topical formulations are effective for acne treatment wherein oral medication need not be given or are contraindicated." please revise. This sentence has many spelling and grammar mistakes. Furthermore, it is a very convoluted sentence that is not clear on what the aims are.

Aims and objectives
1. "To research the effectiveness tazarotene gel of 0.05% to that of adapelene gel of 0.1%." is not a clear sentence. DO you mean you want to compare the effectiveness of tazarotene to that of adapalene?

Methods
1. "a thorough background containing information on your age, gender, educational level, socioeconomic standing, employment, marital status, occupation, past drug use, and the length of the application will be taken." Please correct sentence to read .... information on patient's age.....
2. "Patients will be randomized into one of two groups (Group A and Group B) by straight forward randomization by computer-generated numbers. Group A will be prescribed Tazarotene 0.05% gel along with Tab Azee 500 mg thrice weekly for 12 weeks and Group B will be prescribed Adapalene 0.1% gel along with Tab Azee 500 mg thrice weekly." What is the rational of adding azythromycine? Since oral antibiotics have anti-inflammatory effect, could this potentially alter your result to test the effectiveness of tazarotene versus adapalene?
3. "For assessment of improvement a system of scoring will be called Global Acne Scoring (Table 1) be used when the patient is being enrolled and also with every consecutive follow-up" Revise English grammar.
4." It will also be mentioned that retinoids have negative effects, including dryness, erythema, acne flare-ups, and itching. " perhaps should read as "It will also be mentioned IF retinoids have negative effects, including dryness, erythema, acne flare-ups, and itching."
6. "The method application that will be explained to the patient will include the application of tazarotene on the acne lesions overnight on a properly washed clean face." Were retinoids only applied to acne lesion or to the entire face? This distinction is importante because retinoids not only improve active acne lesions but they also prevent the appearance of new acne lesions by impacting on hyperkeratinization and consequently on the formations of the microcomedone
7. "The study will have a total 12 weeks (3 months) follow-up duration. The patient will be called for follow-up every fortnight during this tenure." What is a fortnight? Not every reader will understand what that means (including myself)

OUTCOME MEASURES
1. "To observe the improvement in the acne of patients based on Global Acne Scoring systems, keeping a note of the decrease in the number of counts of lesions with every follow-up visit or clearance of lesions, subjective patient improvement scoring, and the side effects that arise with the usage of 0.05% tazarotene and 0.1% adapalene." Incomplete sentence. Perhaps you meant: The aim was To observe the improvement in the acne of patients based on Global Acne Scoring systems, keeping a note of the decrease in the number of counts of lesions with every follow-up visit or clearance of lesions, subjective patient improvement scoring, and the side effects that arise with the usage of 0.05% tazarotene and 0.1% adapalene.

Scope
"To add newer topical drugs for reating patients of facial acne." You probably meant "treating" and not "reating"
2. "To study the effect of tazarotene with other systemic drugs in combinations." this was not stated in your objectives
3. "To study the effect of tazarotene with combinations with other topical agents." What other topical agents?
Discussion
1. "A safe and efficient topical treatment for acne appears to be topical tazarotene with the exception of ovulating females, in whom proper safety precautions should be taken" all topical retinoids are safe in "ovulating women" they just cannot be used during pregnancy and should be stopped as soon as a pregnancy is detected.
2. "Acne on face was treated with tazarotene gel of 01% and adapelene gel of 0.1%. in a study in 106 acne patients. Every patient had a thorough clinical examination. The efficiency of daily use of tazarotene gel of 0.05% and adapalene gel of 0.1% for the treatment of facial acne vulgaris were evaluated in a multicenter, double-blind, randomised comparison research" Please revise this sentence as it is confusing
2. "Our findings will be in line with the said research." How do you know if the study is ongoing? Do you have preliminary data that is not shown here? This could potentially indicate researcher bias.....

Conclusion
1. "This is a randomised controlled study wherein we compare the efficacy of 0.05% tazarotene gel to 0.1% adapelene gel in grade I to III patients with acne vulgaris." Revise grammar. Perhaps is should be: This is a randomised controlled study wherein we compare the efficacy of 0.05% tazarotene gel to 0.1% adapelene gel in patients with acne vulgaris grade I to III.
2. "This study’s significance lies in the addition of newer topical medications and the examination of the interaction between tazarotene and other systemic medications. Also to study the effect of tazarotene with combinations with other topical agents that will help us find better effective modality for patient of acne on the face." Please revise, confusing language and sentence structure"

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. Valente Duarte de Sousa IC: Guidance for the pharmacological management of acne vulgaris.Expert Opin Pharmacother. 2022; 23 (1): 49-62 PubMed Abstract | Publisher Full Text
2. Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, et al.: Guidelines of care for the management of acne vulgaris.J Am Acad Dermatol. 2016; 74 (5): 945-73.e33 PubMed Abstract | Publisher Full Text
3. Oon HH, Wong SN, Aw DCW, Cheong WK, et al.: Acne Management Guidelines by the Dermatological Society of Singapore.J Clin Aesthet Dermatol. 2019; 12 (7): 34-50 PubMed Abstract
4. Reynolds RV, Yeung H, Cheng CE, Cook-Bolden F, et al.: Guidelines of care for the management of acne vulgaris.J Am Acad Dermatol. 2024. PubMed Abstract | Publisher Full Text
5. Nast A, Dréno B, Bettoli V, Bukvic Mokos Z, et al.: European evidence-based (S3) guideline for the treatment of acne - update 2016 - short version.J Eur Acad Dermatol Venereol. 2016; 30 (8): 1261-8 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Acne and hair diseases

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

CITE

Report a concern

Respond or Comment

Comments on this article Comments (0)

Version 1

VERSION 1 PUBLISHED 15 Nov 2023

Open Peer Review

Reviewer Status

Reviewer Reports

	Invited Reviewers
	1	2
Version 1 15 Nov 23	read	read

Isabel Cristina Valente Duarte de Sousa, Hospital ABC Campus Santa Fe, Mexico City, Mexico
PRASETYADI MAWARDI, Sebelas Maret University, Surakarta, Indonesia

Comments on this article

All Comments(0)

Add a comment

Sign up for content alerts

Browse by related subjects

Back to all reports

Reviewer Report

1 Views

25 May 2024 | for Version 1

PRASETYADI MAWARDI, Sebelas Maret University, Surakarta, Indonesia

1 Views Cite this report Responses(0)

Approved

This study opens new horizons in the use of vitamin A acid derivatives, Tazarotene and adapalene in the management of Acne Vulgaris (AV). In various references, these two topical drugs are said to have fewer side effects than tretinoin. However, the effectiveness of both in the treatment of AV has not been widely studied.

Authors must provide in-depth arguments about:

Why are all degrees of acne vulgaris used as research subjects, whether classified as mild, moderate and severe AV?
Why does mild AV also receive Azithromycin 500mg trice a week therapy, receiving the same treatment as moderate AV and severe AV?
How do we minimize confounding factors, do moderate AV and severe AV show improvement due to topical administration of Tazarotene or Adapalene compared to the effect of Azithromycin 500mg trice a week, in overcoming the inflammatory process or due to Cutibacterium acnes infection?
How do the authors assess the role of Psychoneuroimmunological or Psychodermatological factors that are closely related to moderate and severe AV in groups of adolescent children?

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Yes

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Clinical dermatology, Cosmetic dermatology, Skin cancer, Skin Surgery, Sexually Transmitted Infection

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Respond to this report

Responses (0)

Back to all reports

Reviewer Report

1 Views

06 Mar 2024 | for Version 1

Isabel Cristina Valente Duarte de Sousa, Hospital ABC Campus Santa Fe, Mexico City, Mexico

1 Views Cite this report Responses(0)

Approved With Reservations

"General comments
Please revise the text for proper English grammar, since there are many mistakes throughout the text
The study design is not clear. Were the retinoids applied all over the face or just over active acne lesions?

Specific comments:
Introduction
1. Papules are not the same as erythematous pustules. Papules have a solid interior while pustules have a liquid one.
2. You missed the most important type of acne lesion, the one that precedes all others: the comedone
3. About the pathogenic mechanisms involved in the appearance of acne lesions: the abnormal infundibular keratinization leads to hyperkeratinization.
4. why is it important to mention that keratinocytes in comedones have more desmosomes or monofilaments?
5. The sentence "A pilosebaceous follicular disorder....." is incomplete. Perhaps it should read: Acne is a pilosebaceous follicular disorder.....
6. The sentence "Regardless of color and ethnicity, everyone between the ages of 12 and 17 must have occasionally....." sounds like speculation
7. The sentence "Therefore, it is therefore...." is repetitive and doesn't convey why early treatment of acne is important. Do you mean that the treatment of acne is crucial to manage early because many patients experience it? Perhaps it could be better explained that treatment of acne is important because regardless of severity it impacts the patient's quality of life.
8. "Since they have so many different mechanism of action, retinoids...." could be better stated as: retinoids act on most of the pathogenic mechanisms involved in the appearance of acne lesions.
9. " These are selective for a subset of retinoic acid receptors, also unlike Tretinoin, that exhibits lower toxicologic risk and results in less side effects" this is badly stated and perhaps should read: These are selective for a subset of retinoic acid receptors, that unlike Tretinoin, exhibit lower toxicologic risk and results in less side effects
10. "This study focuses primarily on the effectiveness of Adapalene gel of 0.1% applied topically and Tazarotene gel of 0.05% applied topically in order to find a modality of treatment for facial acne vulgaris that is more effective because very few clinical trials based on the basis of effectivity and toleranace of tazarotene gel of 0.05% to that of adapelene gel of 0.1% have been performed." This sentence is confusing and needs revision. Do you mean that the aim of this study is to compare the effectiveness and safety of Adapalene versus tazarotene?

Rationale
1. "One of the skin conditions that causes emotional trauma, feelings of inferiority, and insecurity, acne is one of the skin conditions that today’s teenagers worry about the most. Consequently, it is now important to manage acne at an early stage." Please revise the English in this sentence. Perhaps it should read: Acne is one of the skin conditions that today's teenagers worry about the most as it causes emotional trauma, feelings of inferiority and insecurity.
2. "The drug also increases the expression of three distinct genes called TIG-1, TIG-2, and TIG-3 are the three genes that may have an antiproliferative effect." should be corrected to: The drug also increases the expression of three distinct genes called TIG-1, TIG-2, and TIG-3 which are genes that may have an antiproliferative effect.
3. "Instead of an indirect effect linked to the improvement of disease, the result of tazarotene on these indicators is likely an influence on expression of genes". Please revise this sentence, as it does not convey a clear message.
4. "Retinoids are frequently used as a last resort to cure acne, but they also have a few negative effects." This statement is not true at all. Retinoids are the mainstay of current acne therapy. Please check current treatment guidelines by the AAD and EADV
5. "Therefore, it is crucial to create a study that focuses on comapritive study between these two. Also this study will help us infer to which topical formulations are effective for acne treatment wherein oral medication need not be given or are contraindicated." please revise. This sentence has many spelling and grammar mistakes. Furthermore, it is a very convoluted sentence that is not clear on what the aims are.

Aims and objectives
1. "To research the effectiveness tazarotene gel of 0.05% to that of adapelene gel of 0.1%." is not a clear sentence. DO you mean you want to compare the effectiveness of tazarotene to that of adapalene?

Methods
1. "a thorough background containing information on your age, gender, educational level, socioeconomic standing, employment, marital status, occupation, past drug use, and the length of the application will be taken." Please correct sentence to read .... information on patient's age.....
2. "Patients will be randomized into one of two groups (Group A and Group B) by straight forward randomization by computer-generated numbers. Group A will be prescribed Tazarotene 0.05% gel along with Tab Azee 500 mg thrice weekly for 12 weeks and Group B will be prescribed Adapalene 0.1% gel along with Tab Azee 500 mg thrice weekly." What is the rational of adding azythromycine? Since oral antibiotics have anti-inflammatory effect, could this potentially alter your result to test the effectiveness of tazarotene versus adapalene?
3. "For assessment of improvement a system of scoring will be called Global Acne Scoring (Table 1) be used when the patient is being enrolled and also with every consecutive follow-up" Revise English grammar.
4." It will also be mentioned that retinoids have negative effects, including dryness, erythema, acne flare-ups, and itching. " perhaps should read as "It will also be mentioned IF retinoids have negative effects, including dryness, erythema, acne flare-ups, and itching."
6. "The method application that will be explained to the patient will include the application of tazarotene on the acne lesions overnight on a properly washed clean face." Were retinoids only applied to acne lesion or to the entire face? This distinction is importante because retinoids not only improve active acne lesions but they also prevent the appearance of new acne lesions by impacting on hyperkeratinization and consequently on the formations of the microcomedone
7. "The study will have a total 12 weeks (3 months) follow-up duration. The patient will be called for follow-up every fortnight during this tenure." What is a fortnight? Not every reader will understand what that means (including myself)

OUTCOME MEASURES
1. "To observe the improvement in the acne of patients based on Global Acne Scoring systems, keeping a note of the decrease in the number of counts of lesions with every follow-up visit or clearance of lesions, subjective patient improvement scoring, and the side effects that arise with the usage of 0.05% tazarotene and 0.1% adapalene." Incomplete sentence. Perhaps you meant: The aim was To observe the improvement in the acne of patients based on Global Acne Scoring systems, keeping a note of the decrease in the number of counts of lesions with every follow-up visit or clearance of lesions, subjective patient improvement scoring, and the side effects that arise with the usage of 0.05% tazarotene and 0.1% adapalene.

Scope
"To add newer topical drugs for reating patients of facial acne." You probably meant "treating" and not "reating"
2. "To study the effect of tazarotene with other systemic drugs in combinations." this was not stated in your objectives
3. "To study the effect of tazarotene with combinations with other topical agents." What other topical agents?
Discussion
1. "A safe and efficient topical treatment for acne appears to be topical tazarotene with the exception of ovulating females, in whom proper safety precautions should be taken" all topical retinoids are safe in "ovulating women" they just cannot be used during pregnancy and should be stopped as soon as a pregnancy is detected.
2. "Acne on face was treated with tazarotene gel of 01% and adapelene gel of 0.1%. in a study in 106 acne patients. Every patient had a thorough clinical examination. The efficiency of daily use of tazarotene gel of 0.05% and adapalene gel of 0.1% for the treatment of facial acne vulgaris were evaluated in a multicenter, double-blind, randomised comparison research" Please revise this sentence as it is confusing
2. "Our findings will be in line with the said research." How do you know if the study is ongoing? Do you have preliminary data that is not shown here? This could potentially indicate researcher bias.....

Conclusion
1. "This is a randomised controlled study wherein we compare the efficacy of 0.05% tazarotene gel to 0.1% adapelene gel in grade I to III patients with acne vulgaris." Revise grammar. Perhaps is should be: This is a randomised controlled study wherein we compare the efficacy of 0.05% tazarotene gel to 0.1% adapelene gel in patients with acne vulgaris grade I to III.
2. "This study’s significance lies in the addition of newer topical medications and the examination of the interaction between tazarotene and other systemic medications. Also to study the effect of tazarotene with combinations with other topical agents that will help us find better effective modality for patient of acne on the face." Please revise, confusing language and sentence structure"

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

No
Are sufficient details of the methods provided to allow replication by others?

No
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. Valente Duarte de Sousa IC: Guidance for the pharmacological management of acne vulgaris.Expert Opin Pharmacother. 2022; 23 (1): 49-62 PubMed Abstract | Publisher Full Text
2. Zaenglein AL, Pathy AL, Schlosser BJ, Alikhan A, et al.: Guidelines of care for the management of acne vulgaris.J Am Acad Dermatol. 2016; 74 (5): 945-73.e33 PubMed Abstract | Publisher Full Text
3. Oon HH, Wong SN, Aw DCW, Cheong WK, et al.: Acne Management Guidelines by the Dermatological Society of Singapore.J Clin Aesthet Dermatol. 2019; 12 (7): 34-50 PubMed Abstract
4. Reynolds RV, Yeung H, Cheng CE, Cook-Bolden F, et al.: Guidelines of care for the management of acne vulgaris.J Am Acad Dermatol. 2024. PubMed Abstract | Publisher Full Text
5. Nast A, Dréno B, Bettoli V, Bukvic Mokos Z, et al.: European evidence-based (S3) guideline for the treatment of acne - update 2016 - short version.J Eur Acad Dermatol Venereol. 2016; 30 (8): 1261-8 PubMed Abstract | Publisher Full Text

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Acne and hair diseases

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Respond to this report

Responses (0)

[1] 1. Layton AM: Disorders of the Sebaceous Glands.Burns T, Breathnach S, Cox N, et al., editors. Rook’s Textbook of Dermatology. 8th ed.Oxford: Wiley-Blackwell Scientific Publications; 2010; p 42.17. Publisher Full Text

[2] 2. James WD: Clinical practice. Acne. N. Engl. J. Med. 2005; 352: 1463–1472. Publisher Full Text

[3] 3. Toyoda M, Morohashi M: Pathogenesis of acne. Med. Electron Microsc. 2001 Mar; 34(1): 29–40. Publisher Full Text

[4] 4. Aktans OE, Sanli B: Anxiety, Depression and Nature of Acne vulgaris in Adolescents. Int. J. Dermatol. 2000; 39: 354–357. PubMed Abstract | Publisher Full Text

[5] 5. Smithard A, Glazebrook C, Williams HC: Acne prevalence, knowledge about acne and psychological morbidity in midadolescence: a community – m based study. Br. J. Dermatol. 2001; 145: 274–279. PubMed Abstract | Publisher Full Text

[6] 6. Duvic M, Nagpal S, Asano AT, et al.: Molecular mechanisms of tazarotene action in psoriasis. J. Am. Acad. Dermatol. 1997 Aug 1; 37(2): S18–S24. PubMed Abstract | Publisher Full Text

[7] 7. Anjum K, Altaf F, Shahzadi N, et al.: Comparison of Efficacy of 0.1% Tazarotene Versus 0.1% Adapalene for the Treatment of Mild Acne Vulgaris. Pak. J. Med. Health Sci.2020; 14(1): 63–66.

[8] 8. Doshi A, Zaheer A, Stiller MJ: A comparison of current acne grading systems and proposal of a novel system. Int. J. Dermatol. 1997 Jun; 36(6): 416–418. PubMed Abstract | Publisher Full Text

[9] 9. Rahman MH, Sikder MS, Khondker L: Efficacy and tolerability of 0.1% tazarotene cream and 0.05% tretinoin cream in the treatment of acne vulgaris. Bangabandhu Sheikh Mujib Med. Univ. J. 2015; 8(1): 24–29. Publisher Full Text

[10] 10. Bershad S, Singer GK, Parente JE, et al.: Successful treatment of acne vulgaris using a new method: results of a randomized vehicle-controlled trial of short-contact therapy with 0.1% tazarotene gel. Arch. Dermatol. 2002 Apr 1; 138(4): 481–489. PubMed Abstract | Publisher Full Text

[11] 11. Noor N, Paracha MM, Kamal K, et al.: Comparison of the efficacy of tazarotene 0.1% gel with adapalene 0.1% gel in the treatment of facial acne vulgaris. J. Postgrad. Med. Inst. 2021 Apr 1; 35(2).

[12] 12. Webster GF, Guenther L, Poulin YP, et al.: A multicenter, double-blind, randomized comparison study of the efficacy and tolerability of once-daily tazarotene 0.1% gel and adapalene 0.1% gel for the treatment of facial acne vulgaris. Cutis. 2002 Feb 1; 69(2 Suppl): 4–11. PubMed Abstract

Comparison between Tazarotene 0.05% gel and Adapelene 0.1% gel in acne patients

Abstract

Keywords

Introduction

Rationale

Aims and objectives

Methods

Study design

Sample size

Inclusion criteria

Exclusion criteria

Methods

Table 1. Global acne scoring criteria.

Outcome measure

Statistics

Scope

Study status

Discussion

Conclusion

Data availability

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Reviewer Reports

Comments on this article

Browse by related subjects

Competing Interests Policy

Stay Updated