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

Primary Purpose

Acne Vulgaris Superficial Mixed Comedonal and Inflammatory

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Flutamide 1% gel

topical gel without flutamide

About this trial

This is an interventional treatment trial for Acne Vulgaris Superficial Mixed Comedonal and Inflammatory

Eligibility Criteria

16 Years - 40 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

Reham Essam

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A (Flutamide group)

Group B (control group)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

side effects

scaling, stinging, erythema, dryness

Full Information

NCT ID

NCT05478330

First Posted

July 14, 2022

Last Updated

July 27, 2022

Sponsor

Zagazig University

1. Study Identification

Unique Protocol Identification Number

NCT05478330

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

January 13, 2021 (Actual)

Primary Completion Date

June 30, 2022 (Actual)

Study Completion Date

June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris Superficial Mixed Comedonal and Inflammatory

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A (Flutamide group)

Arm Type

Experimental

Arm Description

Arm Title

Group B (control group)

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Flutamide 1% gel

Intervention Description

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

Intervention Name(s)

topical gel without flutamide

Intervention Description

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.

Primary Outcome Measure Information:

Title

changes in the number of comedones, papules, and pustules

Description

Time Frame

up to 8 weeks

Secondary Outcome Measure Information:

Title

side effects

Description

scaling, stinging, erythema, dryness

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Reham Essam

City

Zagazig

State/Province

Al Sharqia

ZIP/Postal Code

2543

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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