Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

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.

Brief Summary

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

Study Phase

Phase 3

Study Type

Interventional

Primary Outcome

Change from baseline in hair density.

Secondary Outcome

 Incidence and severity of adverse events recorded during the study.

Condition

Androgenetic Alopecia

Intervention

Finlândia Association + finasteride placebo

Study Arms / Comparison Groups

 FINLÂNDIA

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

190

Start Date

October 2021

Completion Date

September 2023

Primary Completion Date

April 2023

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;
      

Gender

Male

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

, +551938879851, [email protected]

NCT ID

NCT04594018

Organization ID

EMS2119 - FINLÂNDIA

Responsible Party

Sponsor

Study Sponsor

EMS

Study Sponsor

, , 

Verification Date

October 2020