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العنوان
efficacy and safety of dapsone gel 5% versus adapalene 0.1 gel in treatment of acne vulgaris.
المؤلف
el-sayed,Basma Waheed.
هيئة الاعداد
باحث / بسمه وحيدالسيد سباعي
مشرف / أحمـــد كمـــال الجـــرف
مشرف / أميـــن محمـــدعـــامـــر
مشرف / أحمـــد كمـــال الجـــرف
تاريخ النشر
2019.
عدد الصفحات
B143.
اللغة
الإنجليزية
الدرجة
ماجستير
التخصص
الأمراض الجلدية
الناشر
تاريخ الإجازة
1/1/2019
مكان الإجازة
جامعة الزقازيق - كلية الطب البشرى - الأمراض الجلدية والتناسلية وطب الذكوره
الفهرس
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Abstract

Acne vulgaris is one of the most common cutanaous disorders, with a chronic course that may last beyond the teenage years. Many therapeutic options currently exist to treat acne including topical and oral antibacterial. While antibacterials have anti-inflammatory effect, these agents have been primarily relied upon decreasing the number of p.acnes. The need for long term, continuous or intermittent treatment for acne raises the concern for targeting the inflammatory component of acne by mechanisms that differ from those of conventional antibacterials.
Dapsone, as an anti-inflammatory agent, introduced in the 1950, was observed to be effective in the treatment of severe nodulocystic acne in a limited number of cases. However, the potential for systemic toxicities hindered the widespread use of dapsone in the treatment of acne. A topical formulation of dapsone 5% gel was approved for the treatment of acne.
This work aimed to evaluate of the efficacy of dapsone gel 5% compared with adapalene gel 0.1% in the treatment of acne vulgaris and assess safety profile of dapsone gel 5%.
In order to achieve this aim, this study was carried out on 50 patients with mild to moderate inflammatory acne vulgaris; they were divided in to two groups:-
• group I (25 patients):- Used dapsone gel 5% twice daily for 12 weeks.
• group II (25 patients):- used adapalene gel 0.1% once`daily for 12 weeks.
Follow up was done at 2, 4, 6, 8, 12 weeks to observe clinical changes and any side effects or complications. Digital photography of the patients, at baseline and every 2 weeks were taken till the end of the study.
The results of this study revealed the following:
The age ranged from 13-27 years in group I with a mean age of 16.84±SD 3.40while in group II the age of the patients ranged from 13 -25 years with a mean age of 16.64 ±SD 3.21. There was no significant difference between the two studied groups regarding age (p =0.832). The most frequent age group was less than 20 years in both groups.
In group I, 72 % (n=18) of patients were female and 28% (n=7) were male and in group II, 76% (n=19) of patients were female and 24% (n=6) were male. There was no significant difference between the two studied groups regarding sex (p=0.747).
The duration of acne ranged from2-72months in both groups with a mean of 24.68±SD19.25 in group I and 28.76±SD23.39 in group II. There was no significant difference between the two studied groups regarding duration of the disease (p=0.637).
In group I the number of patients who had positive family history of acne vulgaris was 12 (84%) whereas 13patients (52%) had negative family history. In group II the number of patients who had positive family history of acne vulgaris was 9 (36%) whereas 16patients (64%) had negative family history. There was no significant difference between the two studied groups regarding duration of the disease (p=0.39).
In group I the number of patients who had history of previous treatment to acne vulgaris was 15 (60%) whereas 10patients (40%) had no history of previous treatment. In group II the number of patients who had history of previous treatment to acne vulgaris was 21 (84%) wheras4patients (16%) had no history previous treatment. There was no significant difference between the two studied groups regarding duration of the disease (p=0.059).
Efficacy Assessments:
In Dapsone gel 5% group, the mean number of inflammatory lesions count decreased 33.80± SD12.82to11.56±SD8.16after 12 weeks therapy and the percent of change was65.94%± SD 8.16, while in Adapalene gel 0.1% group, the mean number of inflammatory lesions count decreased from 35.08±SD13.02to was14.80± SD 8.19after 12 weeks therapy and the percent of change was59.2%±SD8.19. There were higher mean percentage reduction in inflammatory lesions counts from baseline in the patients of dapsone group than in the patients of adapalene all visits of follow-up, with statistically significant differences at weeks 2&4.
In Dapsone gel 5% group, the mean number of non-inflammatory lesion counts decreased from 39.79±SD10.89 to22.89±SD 10.43 after 12 weeks therapy and the percent of change was 42.4±SD 10.43%, while in Adapalene gel 0.1% group, the mean number of non-inflammatory lesion counts decreased from47.20±SD 19.25to16.05±SD 12.43 and the percent of change was65%±SD 12.43. There were lower mean number of non-inflammatory lesions in the patients of adapalene group than in the patients of dapsone group with statistically significant differences at week12 (p<0.05).
There were higher mean percentage reduction in non-inflammatory lesions counts from baseline in the patients of adapalene group with statistically significant differences at weeks 2&4&12 (p<0.05).
The mean number of the total lesions in dapsone gel 5% group decreased from 73.00±SD 20.20 to 33.84±SD 10.43 and the percent of change was 53.6±SD 17.50, while in Adapalene gel 0.1% group The mean number of the total lesions decreased from 84.05±SD 20.56 to30.85±SD17.01 and the percent of change was63.2±SD17.01.
Statistically there was a significant difference between the dapsone gel 5% over adapalene gel0.1% regarding the total number of lesions at 2nd week. There were higher mean percentage reduction in total lesions counts from baseline in the patients of adapalene group than in the patients of dapsone group with statistically significant difference at week 8&12 of follow-up (p<0.05).
There was higher success rate in the patients of adapalene group than in the patients of dapsone group with statistically significant differences (p<0.05).
Safety assessments
In dapsone gel 5% group, two patients suffered from mild erythema, one patient had dryness while in adapalene gel 0.1% group, two patients suffered from erythema, four patients had scalling , one patient had dryness and one patient had burning. There were no statistically significant difference between both groups regarding side effects (p>0.05).
By doing complete blood picture to the patients treated with dapsone gel 5% before treatment and at the end of the study (at 12 weeks) there was no significant change in hemoglobin level before and after treatment.