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Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

Primary Purpose

Androgenetic Alopecia

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Finlândia Association + finasteride placebo
Minoxidil + finasteride
Sponsored by
EMS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring androgenetic alopecia

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept 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;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    FINLÂNDIA

    Minoxidil + finasteride

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Incidence and severity of adverse events recorded during the study.

    Full Information

    First Posted
    October 14, 2020
    Last Updated
    August 3, 2022
    Sponsor
    EMS
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04594018
    Brief Title
    Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
    Official 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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    April 2025 (Anticipated)
    Study Completion Date
    September 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EMS

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Androgenetic Alopecia
    Keywords
    androgenetic alopecia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    190 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    FINLÂNDIA
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Minoxidil + finasteride
    Arm Type
    Active Comparator
    Arm 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.
    Intervention Type
    Drug
    Intervention Name(s)
    Finlândia Association + finasteride placebo
    Intervention Description
    Finlândia association hair lotion + finasteride placebo
    Intervention Type
    Drug
    Intervention Name(s)
    Minoxidil + finasteride
    Intervention Description
    Minoxidil hair lotion + Finasteride 1 mg
    Primary Outcome Measure Information:
    Title
    Change from baseline in hair density.
    Description
    Digital phototrichogram evaluation of vertex area regarding the change from baseline in number of hairs after 6 months of treatment compared to baseline.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Incidence and severity of adverse events recorded during the study.
    Time Frame
    6 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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;
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Monalisa FB Oliveira, MD
    Phone
    +551938879851
    Email
    pesquisa.clinica@ncfarma.com.br

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

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