Last updated: February 15, 2024
Sponsor: EMS
Overall Status: Active - Recruiting
Phase
3
Condition
Male Pattern Baldness
Hair Loss
Alopecia
Treatment
Minoxidil + finasteride
Finlândia Association + finasteride placebo
Clinical Study ID
NCT04594018
EMS2119 - FINLÂNDIA
Ages 18-60 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Ability to confirm voluntary participation and agree to all trial purposes by signingand dating the informed consent forms;
- Men aged 18 years or over and less than or equal to 60 years with a diagnosis ofAndrogenetic Alopecia grades IIIv to IV in the modified Norwood-Hamiltonclassification, who have been using minoxidil 5% for at least 3 months and willing tomaintain the same style, approximate length and hair color throughout the test.
Exclusion
Exclusion Criteria:
- Known hypersensitivity to the formula components used during the clinical trial;
- History of alcohol and/or substance abuse within 2 years;
- Participants with other concomitant dermatological diseases on the scalp, except formild seborrhoea dermatitis;
- Participants with a history of surgical treatment for hair loss or shaved scalp;
- Participants who used shampoo or topical solution containing ketoconazole, tar,selenium, threonine or steroids in the last 2 weeks;
- Participants who used 5α reductase inhibitors, such as finasteride and dutasteride, inthe last 12 months;
- Participants using testosterone replacement therapy (TRT) or usingtestosterone-containing gel;
- Participants who used micro-infusion of medications on the skin (MMP), microneedlingor intradermotherapy on the scalp in the last 3 months;
- Participants who have undergone radiation treatment for the scalp or chemotherapy inthe past year;
- Participants with diseases that can affect hair growth;
- Participants with a current medical history of cancer and / or cancer treatment in thelast 5 years;
Study Design
Total Participants: 190
Treatment Group(s): 2
Primary Treatment: Minoxidil + finasteride
Phase: 3
Study Start date:
February 02, 2023
Estimated Completion Date:
September 30, 2025
Connect with a study center
Medcin Instituto Da Pele
Osasco, São Paulo
BrazilActive - Recruiting
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