Treatment of Androgenetic Alopecia in Men for 24 Weeks

NCT ID: NCT04721548

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 336 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-02
• Study Completion Date: 2024-03-06

Brief 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).

Detailed 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.

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

Conditions

Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Minoxidil´s Placebo

The recommended dosage is 1 ml of the solution twice a day (morning and evening).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 mL of solution twice a day.

Topical Minoxidil 5%

The recommended dosage is 1 ml of the solution twice a day (morning and evening).

Group Type: EXPERIMENTAL

Minoxidil Topical Foam

Intervention Type: DRUG

Apply 1 mL of solution twice a day.

Interventions

Minoxidil Topical Foam

Apply 1 mL of solution twice a day.

Intervention Type: DRUG

Placebo

1 mL of solution twice a day.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

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 period of 05 years;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Eurofarma Laboratorios S.A

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EF171

Identifier Type: -

Identifier Source: org_study_id