Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

Last updated: February 15, 2024
Sponsor: EMS
Overall Status: Active - Recruiting

Phase

3

Condition

Male Pattern Baldness

Hair Loss

Alopecia

Treatment

Minoxidil + finasteride

Finlândia Association + finasteride placebo

Clinical Study ID

NCT04594018
EMS2119 - FINLÂNDIA
  • Ages 18-60
  • Male

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Ability to confirm voluntary participation and agree to all trial purposes by signingand dating the informed consent forms;
  • Men aged 18 years or over and less than or equal to 60 years with a diagnosis ofAndrogenetic Alopecia grades IIIv to IV in the modified Norwood-Hamiltonclassification, who have been using minoxidil 5% for at least 3 months and willing tomaintain the same style, approximate length and hair color throughout the test.

Exclusion

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 formild 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, inthe last 12 months;
  • Participants using testosterone replacement therapy (TRT) or usingtestosterone-containing gel;
  • Participants who used micro-infusion of medications on the skin (MMP), microneedlingor intradermotherapy on the scalp in the last 3 months;
  • Participants who have undergone radiation treatment for the scalp or chemotherapy inthe past year;
  • Participants with diseases that can affect hair growth;
  • Participants with a current medical history of cancer and / or cancer treatment in thelast 5 years;

Study Design

Total Participants: 190
Treatment Group(s): 2
Primary Treatment: Minoxidil + finasteride
Phase: 3
Study Start date:
February 02, 2023
Estimated Completion Date:
September 30, 2025

Connect with a study center

  • Medcin Instituto Da Pele

    Osasco, São Paulo
    Brazil

    Active - Recruiting

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