Efficacy and Safety of Finlândia Hair Lotion Association on Androgenetic Alopecia

February 15, 2024 updated by: EMS

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

190

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • São Paulo
      • Osasco, São Paulo, Brazil
        • Recruiting
        • Medcin Instituto Da Pele
        • Contact:
          • FLAVIA ADDOR
          • Phone Number: 551136816362

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

Finlândia association hair lotion + 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.

Minoxidil hair lotion + Finasteride 1 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events recorded during the study.
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2023

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

October 14, 2020

First Submitted That Met QC Criteria

October 14, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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