Treatment of Androgenetic Alopecia in Men for 24 Weeks

• Status: Not yet recruiting
• Trial end date: 2023-07-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Minoxidil

Criteria

Inclusion Criteria:

• Age between 18 and 65 years;

• Male pattern baldness identified according the Nowood scale: stage IIIv vertex, stage IV, or stage V;

• Hair density equal or less than 220 hairs/ cm2 measured with TrichoScan;

• 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 ;

• Medications that can potentiate Hypertrichosis, such as: cyclosporine, phenytoin, psolarenes, oral glucocorticoids (except inhalers), lithium, phenothiazinics.

• 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;