January 31 (1) - 2013 bcps j.pmd

Journal of Bangladesh College of Physicians and SurgeonsVol. 31, No. 1, January 2013 Comparative Safety of 0.1% Tazarotene with 0.05%
Tretinoin in the Treatment of Acne Vulgaris
MH RAHMANa, MS SIKDERb, L KHONDKERc, MSI KHANd, MRU SIDDIQUIe, A NAHIDf Summary:
17.17 in group A and B and at final follow up it was 11.87 ±
A controlled clinical trial was done in the department of
12.04 and 11.20 ± 13.85 respectively (p>0.05). Side effects
Dermatology and Venereology, Bangabandhu Sheikh Mujib
recorded in group A were desquamation (13.3%), dry skin
Medical University, (BSMMU), Dhaka, Bangladesh. The
(6.7%), burning sensation (3.3%) and irritation (3.3%) and
duration of the study was from September 2009 to February
in group B were desquamation (10.0%), dry skin (13.3%),
burning sensation (10.0%), irritation (3.3%) and erythema
2010. Patients of mild type acne vulgaris attending
(3.3%) (p>0.05). But 73.33% of tretinoin treated patient and
outpatient Department of Dermatology (BSMMU), Dhaka
60% of tazarotene treated did not experience any side effects.
were selected by simple random sampling method. A total
Finally we can conclude that 0.1% tazarotene cream and
number of 60 patients were primarily selected and they were
0.05% tretinoin cream is individually safe in the treatment
divided into two groups (Group-A and group-B), group A
of acne vulgaris. And the safety of 0.1% tazarotene cream
was treated with 0.05% tretinoin cream and group B with
is comparable with 0.05% tretinion cream in the treatment
0.1% Tazarotene cream. Mean age of Group A patients was
of mild type of acne vulgaris.
21.73 ± 4.30 and Group B was 19.70 ± 3.44. 43.3% of group
Key words: Safety of 0.1% tazarotene, Safety of 0.05%
A and 53.3% of group B was male and 56.7% of group A
tretinoin, Acne vulgaris.
and 46.7% of group B was female (p=0.438). At baseline
mean of total acne score was 30.57 ± 13.62 and 30.90 ±
(J Bangladesh Coll Phys Surg 2013; 31: 18-22)
Introduction:
scarring.1 Acne vulgaris comprises lesions of varying Acne vulgaris is an extremely common disorder morphology, from comedones, papules, and pustules to affecting up to 95% of the adolescent population and nodules and cysts.2 The pathogenesis of acne is virtually everyone at some point in life. It can lead to multifactorial. Excessive sebum production, sebaceous significant psychological distress and long-lasting follicles with abnormal epithelial hyperkeratinization,the presence of microbial organisms, notably the Dr. Mohammad Habibur Rahman, MBBS, DDV(DU), Junior anaerobic diphtheroid Propionibacterium acnes and Consultant, Dept of Dermatology and Venereology, Upazilla inflammation are the key factors involved. 3 The management of acne can be challenging because of the Professor (Dr) Md Shahidullah Sikder, MBBS, MD(Dermatology), FRCP (Glasgo), Professor, Department of variability in response to treatment and the need for long- Dermatology and Venereology, Bangabandhu Sheikh Mujib term therapy.4 Currently, there is a variety of topical Medical University (BSMMU), Shahbag, Dhaka, Bangladesh.
and systemic therapies that are recommended for the Dr. Lubna Khondker, MBBS, MPH, DDV, MCPS, FCPS treatment of acne, including retinoids, antibiotics, (Dermatology and Venereology), Assistant Professor,Department of Dermatology and Venereology,, Bangabandhu benzoyl peroxide, and hormone therapy.1 Topical Sheikh Mujib Medical University, Shahbag, Dhaka.
retinoids are an integral part of acne therapy and are Major (Dr). Md Shirajul Islam Khan, MBBS, MCPS, DDV, considered appropriate first-line therapy, either alone Graded Specialist in Dermatology and Venereology,, Combined or in combination with antimicrobials, for all cases of Military Hospital (CMH), Jessore Cantt, Jessore.
Dr Md Rahmat Ullah Siddiqui, MBBS, DDV, MCPS, FCPS acne with the exception of the most severe.4 The (Dermatology and Venereology), Research Assistant, abnormal desquamation of follicular epithelium can be Department of Dermatology and Venereology,, Bangabandhu normalized by topical tretinoin. This agent decreases Sheikh Mujib Medical University, Shahbag, Dhaka.
the cohesion of corneocytes, minimize microcomedo Dr Afsana Nahid, MBBS, DDV, FCPS (Dermatology andVenereology), OSD, DGHS, Mohakhali, Dhaka.
formation and in time, decrease both clinical Address of Correspondence: Dr. Lubna Khondker, Assistant
noninflammatory and inflammatory lesions.5 The newer Professor, Department of Dermatology and Venereology, Room-209, synthetic retinoid derivative- tazarotene have Block –B, Bangabandhu Sheikh Mujib Medical University demonstrated effectiveness in the treatment of acne. But (BSMMU), Shahbag, Dhaka, Bangladesh, Mobile- 01552370429,E-mail: lubna_derma@yahoo.com.
lack of proper research on safety background, many Received: 29 May, 2012
Accepted: 27 November, 2012
dermatologists’ have confusion about tolerance of Comparative Safety of 0.1% Tazarotene with 0.05% Tretinoin tazarotene in acne.6 To the best of my knowledge no study exploring the safety of topical Tazarotene A total number of 60 patients were primarily selected comparing with topical tretinoin in the treatment of acne and they were randomized using computer-generated vulgaris has yet been conducted in Bangladesh. The codes into two groups (group-A and group-B), each of current study was aimed to evaluate comparative safety which included 30 patients. Complete history, general of tazarotene cream 0.1% and tretinoin cream 0.05% in physical and dermatological examinations were done the treatment of mild acne vulgaris.
for all enrolled patients. For women of reproductive agereproductive history, menstrual history, lactation and Materials and Methods:
pregnancy plan was carefully judged. History and A controlled clinical trial was done in the department physical findings were recorded in a structured of Dermatology and Venereology, Bangabandhu Sheikh questionnaire. Finally those patients, who matched the Mujib Medical University, (BSMMU), Dhaka, inclusion and exclusion criteria according to history, Bangladesh. The duration of the study was from physical examination and freely gave their informed September 2009 to February 2010. Patients of mild acne consent, were selected for the study.
vulgaris attending outpatient department of dermatology(BSMMU), Dhaka were selected by simple random sampling method after considering the inclusion and Patients were divided into two groups (Group-A and exclusion criteria of patient selection. Inclusion criterias group-B), group A was treated with 0.05% tretinoin were age 13 to 40 years of both sexes, patients cream and group B with 0.1% tazarotene cream. Both conformed to the following washout periods: 14 days preparations had to be administered in once-daily for topical acne medications, 30 days for systemic regimen on both sides of the face at bedtime, and the antibiotics and 12 weeks for estrogen or birth control duration of the total treatment period was 12 weeks.
pills and 12 months for oral retinoids and female who Unused medication were collected after the last agreed to practice appropriate contraceptive measure.
assessment. Patients were clinically assessed monthly Exclusion criterias were skin disorders likely to affect for three months. Each time the severity index of the drug absorption or disorders requiring medical treatmentwithin 5 days before the start of the study; known case disease were calculated and recorded and clinical of topical tazarotene or tretinoin hypersensitivity; history photographs were taken. The final clinical assessment of serious allergic reactions to drug treatment; was done and the severity index was calculated and pregnancy, lactation and/or use of oral contraceptives adverse effects were noted at the end of the third month.
with a specific anti-androgenic action or any oral Then the patient was followed up monthly in the post- contraceptive treatment initiated within 3 months before treatment period for monitoring of all adverse effects.
or during the study and patients suffering from moderate or severe type acne or nodulocystic acne.
Data were edited, coded and entered into the computer.
Statistical analysis was done and level of significance The researcher was duly careful about ethical issues was measured by using appropriate procedures like chi related to this study. In this study the following criteria square test (÷2), relative risk (RR) measurement, t-test, was set to ensure maintaining the ethical values: and proportion (d) test and others where applicable.
Level of significance (p value) was set at 0.05 and All patients were given an explanation of the study including the potential risks and obtainable benefits.
All patients were included in the trial after taking Results:
Mean age of Group A patients was 21.73 ± 4.30 andGroup B was 19.70 ± 3.44. 50.0% of group A and 58.3% The researcher also explained them that they have of Group B was from the age group d”20 and 50.0% of the right to refuse or accept to participate in the group A and 33.3% of group B was from the age group of >20. 43.3% of group A and 53.3% of group B was All data obtained during study period from the male and 56.7% of group A and 46.7% of group B was female (p=0.438). At baseline mean of total acne score Journal of Bangladesh College of Physicians and Surgeons was 30.57 ± 13.62 and 30.90 ± 17.17 in group A and B,at 1st follow up it was 20.50 ± 13.64 and 21.17 ± 16.94respectively in group A and B, at 2nd follow up it was16.23 ± 12.74 and 15.83 ± 15.29 and at final follow upit was 11.87 ± 12.04 and 11.20 ± 13.85 respectively ingroup A and B (p>0.05). Percent reduction of acneseverity from base line to final follow up was 69.20 ±23.41 in group A and 74.77 ± 23.30 in group B(p=0.360). The table II showed that 73.33% of tretinointreated patient and 60% of tazarotene treated patientdid not experience any side effects. Side effects recordedin group A were desquamation (13.3%), dry skin (6.7%),burning sensation (3.3%) and irritation (3.3%) and ingroup B were desquamation (10.0%), dry skin (13.3%),burning sensation (10.0%), irritation (3.3%) anderythema (3.3%) (p>0.05).
The side effects experienced by patients of different groupsin their first follow up were shown in table IV. In 1st follow-up visit, in group A- desquamation, dry skin, burning Fig.-1: Line chart of the total acne score in different
sensation, irritation and erythema were present in 6.7%, 3.3%, 3.3%, 0% and 3.3% of patients respectively. In groupB desquamation, dry skin, burning sensation, irritation anderythema were present in 3.3%, 0%, 3.3%, 3.3%, and 3.3% Table-II
of patients respectively. In 3rd follow-up visit, in group A- Distribution of side effects observed in the study dry skin, burning sensation were present in 3.3% and 3.3%of patients respectively and desquamation, irritation and erythema were absent in group A. In group B dry skin, burning sensation, irritation and erythema were absent and only desquamation was present in 3.3% cases in 3rd follow-up visit.
Table-III
Distribution of side effects by groups *unpaired t test was done to measure the level of significance #Figure within parentheses indicates in percentage.
Group A = Tretinoin .05% , Group B = Tazarotene cream (0.1%) *Chi-square test was done to measure the level of significance.
Comparative Safety of 0.1% Tazarotene with 0.05% Tretinoin Table-IV
from base line to final follow up was 69.20 ± 23.41 intretinoin group and 74.77 ± 23.30 in group tazarotene Distribution of side effects in 1st follow up (p=0.360). Preliminary data from well-controlled clinical trials suggest that the tolerability of tazarotenein the treatment of acne vulgaris appears to be clinically comparable to that of both tretinoin and adapalene. 11 Side effects were more in tazarotene group than tretinoin group. Side effects recorded in tretinoin treated group were desquamation (13.3% of patietns), dry skin (6.7% of patients), burning sensation (3.3% of patients) and irritation (3.3% of patients). Side effects observed in tazarotene treated group were desquamation (10.0% of patients), dry skin (13.3% of patients), burning sensation (10.0% of patients), irritation (3.3% of patients) and erythema (3.3% of patients). There is no significant difference between two groups (p>0.05). And side effects observed were only mild or trace. 73.33% of Discussion:
tretinoin treated patient and 60% of tazarotene treated The efficacy of tazarotene in acne is well established.
did not experience any side effects. So both tretinion The current study was conducted to evaluate the safety 0.05% and tazarotene 0.1% is safe individually in the of topical 0.1% tazarotene cream in the treatment ofacne vulgaris comparing with topical 0.05% tretinoin treatment of mild acne vulgaris. And safety & tolerability gel. Equal of thirty patients of acne vulgaris were treated of 0.1% tazarotene is comparable to 0.05% tretinoin in with topical 0.1% tazarotene cream and 0.05% tretinoin the treatment of mild acne vulgaris.
gel. Mean age of Group A (Tretinoin) was 21.73 ± 4.30 Conclusion:
and Group B (Tazarotene) was 19.70 ± 3.44, and mean Finally we can conclude that 0.1% tazarotene cream age of acne onset was 19.37 ± 4.07 years and 17.42 ± and 0.05% tretinoin cream is individually safe in the 3.12 years in group A and group B respectively. Different treatment of mild acne vulgaris. And the safety of 0.1% previous studies have reported acne in 28-61% of schoolchildren in the age group 10-12 years; 79-95% in the tazarotene cream is comparable with 0.05% tretinion age group 16-18 years; and even in children in the age cream in the treatment of mild acne vulgaris. Further group 4-7 years.7,8 In India, prevalence data from a multicenter, randomized, double-blind, controlled study dermatology clinic in a teaching hospital in Varanasi should be conducted with large sample size, in future.
reported acne in 50.6% of boys and 38.13% of girls in References:
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