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

NCT ID: NCT05478330

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-13
• Study Completion Date: 2022-06-30

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

Conditions

Acne Vulgaris Superficial Mixed Comedonal and Inflammatory

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group A (Flutamide group)

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 Type: EXPERIMENTAL

Flutamide 1% gel

Intervention Type: DRUG

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.

Group B (control group)

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 Type: PLACEBO_COMPARATOR

topical gel without flutamide

Intervention Type: DRUG

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.

Interventions

Flutamide 1% gel

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.

Intervention Type: DRUG

topical gel without flutamide

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Reham Essam

Lecturer of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Reham Essam

Zagazig, Al Sharqia, Egypt

Countries

Egypt

Other Identifiers

IRB 6597

Identifier Type: -

Identifier Source: org_study_id