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 Information
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]
Administrative Informations
NCT ID
NCT04594018
Organization ID
EMS2119 - FINLÂNDIA
Responsible Party
Sponsor
Study Sponsor
EMS
Study Sponsor
, ,
Verification Date
October 2020