Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FINLÂNDIA The study is double-dummy. The patient must take 1 pill and apply hair lotion as follow: 1 tablet finasteride placebo, oral, once a day. 1 mL Finlândia hair lotion, topical, twice a day. |
Drug: Finlândia Association + finasteride placebo
Finlândia association hair lotion + finasteride placebo
|
| Active Comparator: Minoxidil + finasteride The study is double-dummy. The patient must take 1 pill and apply hair lotion as follow: 1 tablet finasteride, oral, once a day. 1 mL minoxidil hair lotion, topical, twice a day. |
Drug: Minoxidil + finasteride
Minoxidil hair lotion + Finasteride 1 mg
|
Outcome Measures
Primary Outcome Measures
- Change from baseline in hair density. [6 months]
Digital phototrichogram evaluation of vertex area regarding the change from baseline in number of hairs after 6 months of treatment compared to baseline.
Secondary Outcome Measures
- Incidence and severity of adverse events recorded during the study. [6 months]
Eligibility Criteria
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;
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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;
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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;
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- EMS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EMS2119 - FINLÂNDIA