Androgenetic AlopeciaPhase 3NCT04594018
Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia
A Phase 3 study testing Minoxidil + finasteride in people with Androgenetic Alopecia, run by EMS at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Minoxidil + finasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Feb 2023to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Medcin Instituto Da Pele
Osasco, São Paulo
FLAVIA ADDOR, 551136816362
About this study
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.
The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.
- Conditions
- Androgenetic Alopecia
- Being tested
- Finlândia Association + finasteride placebo, Minoxidil + finasteride
- Keywords
- androgenetic alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Finlândia Association + finasteride placeboDrug
Finlândia association hair lotion + finasteride placebo
Minoxidil + finasterideDrug
Minoxidil hair lotion + Finasteride 1 mg
| Study group | Role | What they receive |
|---|---|---|
| FINLÂNDIA | Experimental | 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. Receives: Drug: Finlândia Association + finasteride placebo |
| Minoxidil + finasteride | Active comparator | 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. Receives: Drug: Minoxidil + finasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Incidence and severity of adverse events recorded during the study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start2 Feb 2023
- Primary completionMay 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594018
- Sponsor's protocol ID
- EMS2119 - FINLÂNDIA
- Status last verified
- Dec 2025
- First submitted
- 14 Oct 2020
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04594018
- Acronym / sponsor ID
- EMS2119 - FINLÂNDIA
- Conditions
- Androgenetic Alopecia
- Keywords
- androgenetic alopecia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of Finlândia hair lotion association in the treatment of androgenetic alopecia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FINLÂNDIA | Experimental | Drug: Finlândia Association + finasteride placeboThe 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. |
| Minoxidil + finasteride | Active comparator | Drug: Minoxidil + finasterideThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Finlândia Association + finasteride placeboFinlândia association hair lotion + finasteride placebo | Drug | FINLÂNDIA |
| Minoxidil + finasterideMinoxidil hair lotion + Finasteride 1 mg | Drug | Minoxidil + finasteride |
Primary outcome
Change from baseline in hair density.
Time frame: 6 months
Digital phototrichogram evaluation of vertex area regarding the change from baseline in number of hairs after 6 months of treatment compared to baseline.
1 secondary outcome
Incidence and severity of adverse events recorded during the study.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Androgenetic Alopecia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minoxidil + finasteride in people with Androgenetic Alopecia, run by EMS at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monalisa FB Oliveira, MD (+551938879851, pesquisa.clinica@ncfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in hair density. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.