Efficacy and Safety of APSMNF in the Treatment of Male Androgenetic Alopecia (MONA)

April 7, 2026 updated by: Apsen Farmaceutica S.A.

Phase III Randomized, Multicenter, Double-blind, Parallel Clinical Trial to Evaluate the Efficacy and Safety of APSMNF in the Treatment of Male Androgenetic Alopecia

The purpose of this study is to evaluate the efficacy and safety of APSMNF in the treatment of male androgenetic alopecia.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

336

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

  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Men aged 18 to 60 years with a clinical diagnosis of androgenetic alopecia ;
  • Participants who use an acceptable contraceptive method, or who declare that their partner uses an acceptable contraceptive method, according to the protocol, and who agree to use it throughout the study period.

Exclusion Criteria:

  • History of allergic reactions to any of the active ingredients or to any of the ingredients of teh formulation;
  • Participants with a history of alcohol, substance, or illicit drug abuse disorder in the last 2 years;
  • Participants with conditions that may affect hair growth or with underlying conditions that cause hair loss, such as a diagnosis of alopecia areata, fibrosing or cicatricial alopecia, or telogen effluvium, the latter being present at the time of screening;
  • Participants with concomitant inflammation or other dermatological conditions of the scalp, such as moderate or severe psoriasis or seborrheic dermatitis, and/or active infection and/or keloid formation in the area of alopecia;

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: APSMNF 1
active
Drug: APSMNF 1
Administer twice a day during 24 weeks.
Experimental: APSMNF 2
active
Drug: APSMNF 2
Administer twice a day during 24 weeks.
Active Comparator: Eniagor®
active
Drug: Eniagor®
Administer twice a day during 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Variation in hair density assessed by phototrichogram.
Time Frame: Change from baseline after 24 weeks of treatment.
Change from baseline after 24 weeks of treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events incidence and classification
Time Frame: Through study completion, up to 24 weeks
Through study completion, up to 24 weeks

Collaborators and Investigators

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

Sponsor

Apsen Farmaceutica S.A.

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 (Estimated)

July 7, 2026

Primary Completion (Estimated)

August 2, 2029

Study Completion (Estimated)

August 2, 2029

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APS001/2025

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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