Effect of New Topical Preparation for Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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The investigators propose a randomized, double-blind control trial study to evaluate the efficacy and safety of the optimized topical combination ME of the investigated drugs in the treatment of acne vulgaris containing DAP-FLU in comparison with standard therapy of Adapalene at Mansoura University Dermatology and Andrology Outpatient Clinic.

Official Title
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Potential Combination Topical Therapy of Acne Vulgaris: a Randomized Controlled Trial Comparing Efficacy of DAP/FLU Micro-emulsion vs. Standard Therapy of Adapalene.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: DAP-FLU ME
* Drug: Adapalene .1% gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and females age 12 or older Clinical diagnosis of mild to moderate facial acne vulgaris defined as: ≥ 5 inflammatory lesions, and; ≥ 10 non-inflammatory lesions, and; IGA 2-3 Willing to refrain from using any treatments, other than the investigational product, for acne present on the face. This includes the use of antibiotics for the treatment of acne. Willing and able to provide informed consent and to comply with the study protocol. Exclusion Criteria: Women were excluded if they were pregnant, nursing, or planning a pregnancy as were men with facial hair that would interfere with the assessments. Continuous or planned use of tanning booths or excessive sun exposure, in the opinion of the Investigator. Treatment with systemic corticosteroids within 28 days prior to baseline. Two or more active nodular lesions. Use of androgen receptor blockers (such as spironolactone or flutamide) in the 7 days prior to randomization.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DAP/FLU ME<br>Acne vulgaris patients treated with the optimized topical combination ME contain DAP-FLU. | Drug: DAP-FLU ME<br>* Combination therapy of topical anti-inflammatory agent (Dapsone 5%) and anti-androgenic agent (Flutamide 2.5%) with anti-bacterial agent of micro-emulsion component (tea tree oil 5%)<br>|
| Active Comparator: Adapalene .1% gel<br>Acne vulgaris patients treated with standard therapy of Adapalene. | Drug: Adapalene .1% gel<br>* Adapalene .1% gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Michaelson's acne severity index (ASI) | It's evaluated by counting non-inflammatory lesions (open and closed comedones) and inflammatory lesions (papules, pustules and nodules of at least 5 mm in diameter), and calculated as follows: ASI = (comedones x 0.5) + (papules x 1) + (pustules x 2) + (nodules x 3). | 8 Weeks | 
| Safety assessment by the recording of patient-reported adverse events | Throughout the study | 8 Weeks |