NCT04594018 Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
| NCT ID | NCT04594018 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | EMS |
| Condition | Androgenetic Alopecia |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2023-02-02 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 190 participants in total. It began in 2023-02-02 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.
Eligibility Criteria
Inclusion Criteria: * Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * Men aged 18 years or over and less than or equal to 60 years with a diagnosis of Androgenetic Alopecia grades IIIv to IV in the modified Norwood-Hamilton classification, who have been using minoxidil 5% for at least 3 months and willing to maintain the same style, approximate length and hair color throughout the test. 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 for mild 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, in the last 12 months; * Participants using testosterone replacement therapy (TRT) or using testosterone-containing gel; * Participants who used micro-infusion of medications on the skin (MMP), microneedling or intradermotherapy on the scalp in the last 3 months; * Participants who have undergone radiation treatment for the scalp or chemotherapy in the past year; * Participants with diseases that can affect hair growth; * Participants with a current medical history of cancer and / or cancer treatment in the last 5 years;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04594018 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 60 Years, studying Androgenetic Alopecia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04594018 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 190 participants.
Is NCT04594018 currently recruiting?
Yes, NCT04594018 is actively recruiting participants. Contact the research team at pesquisa.clinica@ncfarma.com.br for enrollment information.
Where is the NCT04594018 trial being conducted?
This trial is being conducted at Osasco, Brazil.
Who is sponsoring the NCT04594018 clinical trial?
NCT04594018 is sponsored by EMS. The trial plans to enroll 190 participants.