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NCT Number: NCT07516561

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

APSMNF 1

Drug

Administer twice a day during 24 weeks.

APSMNF 2

Drug

Administer twice a day during 24 weeks.

Eniagor®

Drug

Administer twice a day during 24 weeks.

Primary outcomes

  1. Variation in hair density assessed by phototrichogram.

    Time frame: Change from baseline after 24 weeks of treatment.

Secondary outcomes

  1. Adverse events incidence and classification

    Time frame: Through study completion, up to 24 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Fernanda Martinez Scalzaretto

CONTACT

[email protected]

+551156448200

Sponsors and collaborators

Lead sponsor

Apsen Farmaceutica S.A.

Industry

Registry information

Official study title

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

Acronym: MONA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Apr 8, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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