Treatment of Androgenetic Alopecia in Men for 24 Weeks

Phase

Condition

Hair Loss

Alopecia

Treatment

Minoxidil Topical Foam

Placebo

Clinical Study ID

NCT04721548

EF171

Ages 18-65
Male
Accepts Healthy Volunteers

Study Summary

A prospective, randomized, double-blind, single-center, placebo-Controlled, parallel-group study to evaluate the efficacy and safety of a new pharmaceutical form Minoxidil 5% in men after 24 weeks of treatment.

⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age between 18 and 65 years;
Male pattern baldness identified according the Norwood Hamilton scale: stage IIIvvertex, stage IV, or stage V;
Terminal hair density equal to or less than 220 hairs/cm2 measured with theTrichoscale Al;
Subjects who are willing and able to comply with all requirements of the study forthe intended period;
Subjects who give their consent to the study after thoroughly clarification and whopersonally signed and dated the informed consent document has been informed of allpertinent aspects of the trial;

Exclusion

Exclusion Criteria:

Current or 6 months dated back use of:
Minoxidil, finasteride, or any 5 alpha-reductase inhibitor;
Medications that can potentiate Hypertrichosis, such as: cyclosporine, phenytoin,psolarenes, oral glucocorticoids (except inhalers), lithium, phenothiazinics
Medications with anti-androgenic properties, such as: cyproterone, spironolactone,ketoconazole, flutamide, bicalutamide.
Any anabolic steroid ;
Current or 8 weeks dated back use of herbal products such as saw palmetto;
Isotretinoin for at least 12 months;
Current or 2 weeks dated back use of dietary or vitamin supplements;
Subjects who had a dignosis of malignant disease in the alopecia area in the periodof 05 years;

Study Design

Minoxidil Topical Foam

March 02, 2023

March 06, 2024

Study Description

Participants will be randomized at a 2: 1 ratio to receive new pharmaceutical form Minoxidil 5% and placebo, respectively. Through this method, it is possible to obtain more information about the effectiveness of investigational product.

The primary objective of the MINOX study is to demonstrate the superiority of a new topical 5% pharmaceutical form of minoxidil (experimental drug) in treating men with androgenetic alopecia (Hamilton-Norwood scale IIIv, IV or V) compared to placebo when administered for 180 days.

Secondary objectives: 1- To evaluate the efficacy of a new topical 5% minoxidil pharmaceutical form in the treatment of men with androgenetic alopecia, compared to placebo, by means of terminal strand density in the target area, evaluated 30 (±3), 60(±3), 90(±3) and 135(±3) days after the beginning of treatment.

2- To evaluate the efficacy of a new topical 5% pharmaceutical form of minoxidil in the treatment of men with androgenetic alopecia, compared to placebo, by means of the percentage of anagen strands in the target area, evaluated 30(±3), 60(±3), 90(±3), 135(±3) and 180(±3) days after the start of treatment.

3- Evaluate the efficacy of a new topical 5% pharmaceutical form of minoxidil in the treatment of men with androgenetic alopecia, compared to placebo, by means of the average length of hair strands in the target area, evaluated 30(±3), 60(±3), 90(±3), 135(±3) and 180(±3) days after the start of treatment.