Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

Phase 3

Recruiting

• Conditions: Androgenetic Alopecia
• Interventions: Drug: Finlândia Association + finasteride placebo; Drug: Minoxidil + finasteride

• Registration Number: NCT04594018
• Lead Sponsor: EMS

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-14
• Study First Submitted QC: 2020-10-14
• Study First Posted: 2020-10-20
• Study Start: 2023-02-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16
• Primary Completion: 2025-04
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 190

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FINLÂNDIA	Finlândia Association + finasteride placebo	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.
Minoxidil + finasteride	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence and severity of adverse events recorded during the study.	6 months

Trial Locations

Locations (1)

Medcin Instituto Da Pele; 🇧🇷 Osasco, São Paulo, Brazil