RecruitingPhase 3NCT04594018

Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

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.

Sponsor

EMS

Enrollment

190 participants

Start Date

Feb 2, 2023

Study Type

INTERVENTIONAL

Conditions

androgenetic alopecia

Summary

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

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 60 Years

Inclusion Criteria2

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 Criteria11

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;