About this trial
Acne vulgaris (AV) is one of the most prevalent dermatological conditions worldwide, affecting approximately 85% of adolescents and young adults between the ages of 12 and 24 years .While acne is often self-limiting, it can have profound psychosocial implications as individuals with acne are more likely to experience emotional distress, lower self-esteem and anxiety disorders .
Acne Vulgaris is a chronic inflammatory skin condition affecting the pilosebaceous units that leads to the development of different skin lesions such as comedones, papules, pustules, nodules and cystic lesions .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with facial acne vulgaris older than 18 years.
Disqualifiers
· Unrealistic expectations.
Unable to follow up.
Severe and nodulocystic AV.
Patients on topical treatment for AV (4 weeks before enrollment) and on systemic treatment for AV (3 months before enrollment).
Trial design
Parallel
Treatments tested in this trial
topical dutasteride
Drug* Group I will be treated by topical Dutasteride 0.05% gel versus placebo (Petrolatum) (split face). * Group II will be treated by topical Dutasteride 0.05% gel versus topical triple fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel (split face).
Treatment groups
Trial outcomes
Primary outcomes
Evaluate and compare the therapeutic efficacy (clinical, microbiological & psychological) of topical Dutasteride 0.05% versus topical fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel in patients with facial AV
o Total lesions count (TLC) (inflammatory lesions and noninflammatory lesions)
Evaluate and compare the therapeutic efficacy (clinical, microbiological & psychological) of topical Dutasteride 0.05% versus topical fixed-dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% gel in patients with facial AV
o The investigator's global assessment (IGA) of acne severity grade modified to assess the half-face acne severity ; Treatment success will be defined as an Investigator's Global Assessment score of 0 (clear) or 1 (almost clear), and a 2-grade or greater improvement from baseline at week 12.
Secondary outcomes
Addressing the safety profile of the two topical therapeutics
By recording side effects by daily diary specifying side effect (whether systemic or topical ,type,site and onset )
Psychological effect of AV and its relation to therapeutic outcomes
Cardiff Acne Disability Index (CADI) will be assessed at first visit and at end of 12 week-study period
Locations
Sponsors and contacts
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