Title - Comparative study of efficacy, safety and cost effectiveness of topical combination therapy with clindamycin 1 %-benzoyl peroxide 2.5 % versus adapalene 0.1% - benzoyl peroxide 2.5% in cases of mild to moderate facial acne vulgaris patients: A prospective, randomized, open label, parallel study

Introduction - Acne is a chronic inflammatory disease of the pilosebaceous units characterized by seborrhoea, formation of open and closed comedones, erythematous papules and pustules and in more severe cases nodules, deep pustules and pseudocysts. Acne vulgaris affects over 80% of teenagers, and persists beyond the age of 25 years in 3% of men and 12% of women. Prevalence of acne vulgaris is 56% in boys and 45% in girls between 14 to 16 years of age group. Facial acne results in impairment of self-image, self-esteem, clinical depression, social phobia and anxiety. Anxiety may be worsened if there is lack of response to acne treatment. For the treatment of mild to moderate acne vulgaris, there are many topical drugs available like benzoyl peroxide, azelaic acid, antibiotics and retinoids, which can be used alone or in combination. After extensive search a published study comparing clindamycin 1%-benzoyl peroxide 2.5% versus adapalene 0.1% - benzoyl peroxide 2.5% combination therapy in indian population could not be found. Hence this study is being conducted to compare the efficacy, safety and cost effectiveness of clindamycin-BPO versus adapalene-BPO combination therapy.

Methodology - The study will be randomized, open label, parallel arm, and prospective study  carried out in a tertiary care hospital of central India from January 2019 to August 2020. A total of 60 patients visiting skin OPD suffering from mild to moderate facial acne as diagnosed by dermatologist will be included into the study.Patients of mild to moderate acne vulgaris attending skin OPD will be interviewed by dermatologist. Subjects fulfilling inclusion criteria will be allocated to one of the two groups (group A and Group B) on the first day of examination. Group A will receive topical clindamycin 1% and benzoyl peroxide 2.5% combination therapy. They will be advised to apply benzoyl peroxide gel first and after 5 min clindamycin to be applied over it, once daily at bed time for 12 weeks. Group B will receive topical adapalene 0.01 % and benzoyl peroxide 2.5% combination therapy. A combination gel of adapalene-benzoyl peroxide will be applied, once daily for 12 weeks. Subject will be called at weeks 4, 8 and 12 for efficacy and safety assessments. Efficacy evaluation will be based on lesion counting. Total lesion count will be done on each follow up visit and will be divided as inflammatory and non-inflammatory lesions. The reduction in number of lesions if any will be noted and percentage reduction will be calculated and graded. Symptoms like erythema, dryness, burning and purities will be recoded on every visit. Assessment of cost effectiveness will also be done in this study. For cost effectiveness analysis, cost effectiveness ratio of both treatment groups will be calculated based on formula (cost effectiveness=cost/outcome) .