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

Zagazig University

Status: Completed

Conditions: Acne Vulgaris Superficial Mixed Comedonal and Inflammatory

Treatments: Drug: topical gel without flutamide; Drug: Flutamide 1% gel

Study type: Interventional

Funder types: Other

Identifiers

NCT05478330

IRB 6597

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 16 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Group A (Flutamide group)

Experimental group

Description:

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.

Treatment:

Drug: Flutamide 1% gel

Group B (control group)

Placebo Comparator group

Description:

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.

Treatment:

Drug: topical gel without flutamide