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

NCT05478330 | Completed

• 1 other identifier: IRB 6597
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acne Vulgaris Superficial Mixed Comedonal and Inflammatory

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• side effects

  8 weeks

Study Arms (2)

Group A (Flutamide group)

EXPERIMENTAL

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

Group B (control group)

PLACEBO COMPARATOR

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

Interventions

Flutamide 1% gel 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 A (Flutamide group)

topical gel without flutamide 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.

Group B (control group)

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Reham Essam

Zagazig, Al Sharqia, 2543, Egypt

Location

MeSH Terms

Interventions

Flutamide; Gels

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Dermatology

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 28, 2022
• Study Start: January 13, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)