Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

EMS

Status and phase: Enrolling; Phase 3

Conditions: Androgenetic Alopecia

Treatments: Drug: Minoxidil + finasteride; Drug: Finlândia Association + finasteride placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04594018

EMS2119 - FINLÂNDIA

Details and patient eligibility

About

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

Enrollment: 190 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 2 patient groups

FINLÂNDIA

Experimental group

Description:

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.

Treatment:

Drug: Finlândia Association + finasteride placebo

Minoxidil + finasteride

Active Comparator group

Description:

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.

Treatment:

Drug: Minoxidil + finasteride