Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

NCT ID: NCT04594018

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2027-09-30

Brief Summary

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

Conditions

Androgenetic Alopecia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Finlândia Association + finasteride placebo

Intervention Type: DRUG

Finlândia association hair lotion + finasteride placebo

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.

Group Type: ACTIVE_COMPARATOR

Minoxidil + finasteride

Intervention Type: DRUG

Minoxidil hair lotion + Finasteride 1 mg

Interventions

Finlândia Association + finasteride placebo

Finlândia association hair lotion + finasteride placebo

Intervention Type: DRUG

Minoxidil + finasteride

Minoxidil hair lotion + Finasteride 1 mg

Intervention Type: DRUG

Eligibility 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;
• 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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medcin Instituto Da Pele

Osasco, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Monalisa FB Oliveira, MD

Role: CONTACT

pesquisa.clinica@ncfarma.com.br

+551938879851

Facility Contacts

FLAVIA ADDOR

Role: primary

551136816362

Other Identifiers

EMS2119 - FINLÂNDIA

Identifier Type: -

Identifier Source: org_study_id