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

Not Applicable

Completed

• Conditions: Acne Vulgaris Superficial Mixed Comedonal and Inflammatory
• Interventions: Drug: Flutamide 1% gel; Drug: topical gel without flutamide

• Registration Number: NCT05478330
• Lead Sponsor: Zagazig University

Brief Summary

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

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

Study Timeline

• Study Start: 2021-01-13
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-27
• Last Update Submitted: 2022-07-27
• Study First Posted: 2022-07-28
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A (Flutamide group)	Flutamide 1% gel	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.
Group B (control group)	topical gel without flutamide	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.

Primary Outcome Measures

Name	Time	Method
changes in the number of comedones, papules, and pustules	up to 8 weeks	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).

Secondary Outcome Measures

Name	Time	Method
side effects	8 weeks	scaling, stinging, erythema, dryness

Trial Locations

Locations (1)

Reham Essam; 🇪🇬 Zagazig, Al Sharqia, Egypt