Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.

Official Title
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National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Clinical Trial to Evaluate the Efficacy and Safety of Finlândia Hair Lotion Association in the Treatment of Androgenetic Alopecia.

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Drug: Finlândia Association + finasteride placebo
* Drug: Minoxidil + finasteride


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FINLÂNDIA<br>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<br>* Finlândia association hair lotion + finasteride placebo<br>|
| Active Comparator: Minoxidil + finasteride<br>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<br>* Minoxidil hair lotion + Finasteride 1 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in hair density. | Digital phototrichogram evaluation of vertex area regarding the change from baseline in number of hairs after 6 months of treatment compared to baseline. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study. |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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androgenetic alopecia