Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

NCT04594018 | Recruiting Phase 3 DMC

• 1 other identifier: EMS2119 - FINLÂNDIA
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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

Keywords

androgenetic alopecia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence and severity of adverse events recorded during the study.

  6 months

Study Arms (2)

FINLÂNDIA

EXPERIMENTAL

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

Minoxidil + finasteride

ACTIVE COMPARATOR

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

Interventions

Finlândia Association + finasteride placebo DRUG

Finlândia association hair lotion + finasteride placebo

FINLÂNDIA

Minoxidil + finasteride DRUG

Minoxidil hair lotion + Finasteride 1 mg

Minoxidil + finasteride

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• EMS: lead

Study Sites (1)

Medcin Instituto Da Pele

Osasco, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Minoxidil; Finasteride

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Azasteroids; Steroids, Heterocyclic

Central Study Contacts

Monalisa FB Oliveira, MD

CONTACT

+551938879851; pesquisa.clinica@ncfarma.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: February 2, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)