Status:
COMPLETED
Treatment of Androgenetic Alopecia in Men for 24 Weeks
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Alopecia
Eligibility:
MALE
18-65 years
Phase:
PHASE3
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 ...
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 effe...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
March 2 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2024
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT04721548
Start Date
March 2 2023
End Date
March 6 2024
Last Update
February 17 2025
Active Locations (1)
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1
Eurofarma Laboratorios S.A
São Paulo, São Paulo, Brazil, 06696-000