Evaluation of Efficacy of Topical Flutamide in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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From the obtained results, topical Flutamide 1% gel can be a promising, effective, and safe alternative in treating patients with acne vulgaris with minimal side effects.

Detailed Description
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Flutamide is a non-steroidal anti-androgen, which is used to treat patients with prostate cancer. Due to its anti-androgenic properties can be used in cases of acne, hirsutism, and androgenic alopecia with successful outcomes. To minimize the unnecessary systemic side effects associated with the oral administration of Flutamide. It has been shown that the topical delivery of Flutamide can allow high drug levels at the site of action, decreasing the systemic side effects and improving patient compliance. The Flutamide group received topical Flutamide 1% gel twice daily on the face for 8 weeks and the control group received the same gel components, without flutamide, twice daily on the face for 8 weeks

Official Title
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Evaluation of Efficacy of Topical Flutamide in the Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris Superficial Mixed Comedonal and Inflammatory

Intervention / Treatment
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* Drug: Flutamide 1% gel
* Drug: topical gel without flutamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fifty adult patients with acne having inflammatory (papules and pustules) and non-inflammatory (comedones) of different sizes, distribution, and durations were included in this study. Exclusion Criteria: Patients with a history of acne treatment with systemic or topical antibiotics, retinoids, or hormonal therapy within the last 3 months. Patients with a history of chronic renal failure, hepatic insufficiency

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A (Flutamide group)<br>Flutamide was supplied in the form of yellow powder and obtained from Sigma Pharmaceutical Industries, Egypt. Tween 80 and Propylene glycol were obtained from Sigma Pharmaceutical Industries, Egypt. Oleic acid was purchased from El Gomhouria Company for Trading Chemicals and Medical Appliances, Egypt. | Drug: Flutamide 1% gel<br>* Group A: Flutamide-treated patients: Consisted of 25 patients with acne vulgaris treated with 1% Flutamide topical gel on the face two times per day for a duration of 8 weeks.<br>|
| Placebo Comparator: Group B (control group)<br>Tween 80 and Propylene glycol were obtained from Sigma Pharmaceutical Industries, Egypt. Oleic acid was purchased from El Gomhouria Company for Trading Chemicals and Medical Appliances, Egypt. | Drug: topical gel without flutamide<br>* Group B: Consisted of 25 patients with acne vulgaris treated with topical gel with the same component as the other group, except for flutamide, on the face twice per day for a duration of 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the number of comedones, papules, and pustules | Response to treatment was evaluated by the changes in the number of comedones, papules, and pustules and by a photographic comparison taken at Baseline ( before treatment) and at 2,4,6, and 8 weeks at (termination of therapy). | up to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects | scaling, stinging, erythema, dryness | 8 weeks |