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NCT Number: NCT04594018

Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

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

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Medcin Instituto Da Pele

Osasco, São Paulo, Brazil

Location status: Recruiting

Location contact

FLAVIA ADDOR

CONTACT

551136816362

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Finlândia Association + finasteride placebo

Drug

Finlândia association hair lotion + finasteride placebo

minoxidil + finasteride

Drug

Minoxidil hair lotion + Finasteride 1 mg

Primary outcomes

  1. Change from baseline in hair density.

    Time frame: 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 outcomes

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

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Monalisa FB Oliveira, MD

CONTACT

[email protected]

+551938879851

Sponsors and collaborators

Lead sponsor

EMS

Industry

Registry information

Official study title

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.

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 20, 2020
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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