Recruiting NCT04594018
Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Finlândia Association + finasteride placebo, Minoxidil + finasteride.
- Who it may be relevant to
- Registry conditions: Androgenetic Alopecia. Basic parameters: 18 years — 60 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.
Interventions
- Drug Finlândia Association + finasteride placebo
Finlândia association hair lotion + finasteride placebo - Drug Minoxidil + finasteride
Minoxidil hair lotion + Finasteride 1 mg
Primary outcome measures
- Change from baseline in hair density. [Time frame: 6 months]
Secondary outcome measures (1)
- Incidence and severity of adverse events recorded during the study. [Time frame: 6 months]
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Medcin Instituto Da Pele — Osasco
Identifiers
NCT: NCT04594018 · EMS2119 - FINLÂNDIA