Actively Recruiting
National, Multicentre, Randomized, Double-blind, Double-dummy Phase III Trial to Evaluate the Efficacy and Safety of Finlândia Hair Lotion Association for Androgenetic Alopecia
Led by EMS · Updated on 2025-12-08
190
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of Finlândia hair lotion combined with oral treatment for men with androgenetic alopecia, a common form of hair loss. This Phase III clinical trial aims to compare this investigational lotion with a combination of minoxidil lotion and finasteride pills to understand which treatment better improves hair density. The study is sponsored by EMS and uses a randomized, double-blind, double-dummy design to ensure unbiased results. Participants will be assigned to one of two groups. One group will take an oral placebo pill and apply 1 mL of Finlândia hair lotion twice daily. The other group will take one oral finasteride pill daily and apply 1 mL of minoxidil lotion twice daily. This treatment period lasts six months, during which participants will follow these dosing schedules closely. During the study, participants' hair density changes will be measured after six months to evaluate treatment effects. Researchers will also monitor and record any adverse events to assess safety. The study involves regular visits for assessments and adherence monitoring. The total participation time is six months, after which participants will complete the study evaluations.
CONDITIONS
Brief Title
Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to voluntarily consent and agree to all trial requirements
- Male aged 18 years or older and 60 years or younger
- Diagnosed with androgenetic alopecia grades IIIv to IV (modified Norwood-Hamilton classification)
- Used minoxidil 5% for at least 3 months
- Willing to maintain similar hair style, length, and color throughout the study
You will not qualify if you...
- Known allergy to any components of the study treatments
- History of alcohol or substance abuse within the past 2 years
- Other scalp skin diseases except mild seborrhoea dermatitis
- Previous surgical treatment for hair loss or shaved scalp
- Used shampoos or topical solutions with ketoconazole, tar, selenium, threonine, or steroids in the last 2 weeks
- Used 5alpha reductase inhibitors like finasteride or dutasteride in the last 12 months
- Using testosterone replacement therapy or testosterone gel
- Used micro-infusion, microneedling, or intradermotherapy on the scalp in the last 3 months
- Received radiation or chemotherapy on the scalp in the past year
- Diseases affecting hair growth
- Current or past cancer treatment within the last 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either Finlândia hair lotion with finasteride placebo or minoxidil hair lotion with finasteride tablets to treat androgenetic alopecia.
Regular visits throughout treatment period
Trial Site Locations
Total: 1 location
1
Medcin Instituto Da Pele
Osasco, São Paulo, Brazil
Actively Recruiting
Research Team
M
Monalisa FB Oliveira, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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