Efficacy and Safety of APSMNF in the Treatment of Male Androgenetic Alopecia

NCT07516561 | Not Yet Recruiting Phase 3

• 1 other identifier: APS001/2025
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alopecia, Androgenetic

Outcome Measures

Primary Outcomes (1)

• Variation in hair density assessed by phototrichogram.

  Change from baseline after 24 weeks of treatment.

Secondary Outcomes (1)

• Adverse events incidence and classification

  Through study completion, up to 24 weeks

Study Arms (3)

APSMNF 1

EXPERIMENTAL

active

Drug: APSMNF 1

APSMNF 2

EXPERIMENTAL

active

Drug: APSMNF 2

Eniagor®

ACTIVE COMPARATOR

active

Drug: Eniagor®

Interventions

APSMNF 1 DRUG

Administer twice a day during 24 weeks.

APSMNF 1

APSMNF 2 DRUG

Administer twice a day during 24 weeks.

APSMNF 2

Eniagor® DRUG

Administer twice a day during 24 weeks.

Eniagor®

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Apsen Farmaceutica S.A.: lead

Study Sites (1)

Clinica Geral Investiga Ltda

Campinas, São Paulo, Brazil

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Fernanda Martinez Scalzaretto

CONTACT

+551156448200; fernanda.martinez@apsen.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): August 2, 2029
• Study Completion (Estimated): August 2, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)