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RecruitingNCT04594018Updated Dec 8, 2025

Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

A Phase 3 interventional study of Finlândia Association + finasteride placebo and Minoxidil + finasteride in Androgenetic Alopecia, sponsored by EMS. Recruiting at 1 site in Brazil. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by EMS · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Feb 2023; still recruiting 3 years 9 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
190
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Androgenetic Alopecia

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Keywords

  • androgenetic alopecia
03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's planned enrollment of 190 is above the median of 50 across 430 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the 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

Exclusion Criteria:

  • Known 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 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;
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
190 participants (estimated)

Study arms

  • Experimental
    FINLÂNDIA

    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.

    Drug: Finlândia Association + finasteride placebo

  • Active comparator
    Minoxidil + finasteride

    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.

    Drug: Minoxidil + finasteride

Interventions

  • DrugFinlândia Association + finasteride placebo

    Finlândia association hair lotion + finasteride placebo

  • DrugMinoxidil + finasteride

    Drug pages: Minoxidil · Finasteride

    Minoxidil hair lotion + Finasteride 1 mg

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. Incidence and severity of adverse events recorded during the study.

    Time frame: 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04594018
Lead sponsor
EMS
Responsible party
Sponsor
First posted
Oct 20, 2020
Start date
Feb 2, 2023
Primary completion
May 2026 (estimated)
Completion
Sep 2027 (estimated)
Last update
Dec 8, 2025

Study contacts

Monalisa FB Oliveira, MD
Contact
pesquisa.clinica@ncfarma.com.br
+551938879851

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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