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A Study Evaluating the Efficacy and Safety of SM04554 Topical Solution in Male Subjects With Androgenetic Alopecia

NCT03742518 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 675

Last updated 2021-12-28

No results posted yet for this study

Summary

This multi-center, randomized, double-blind, placebo-controlled study, conducted in Turkey, will assess the efficacy and safety of topical SM04554 solution (0.15% and 0.25%) applied daily to the scalp of male androgenetic alopecia (AGA) subjects.

Conditions

Interventions

DRUG

Topical SM04554 solution

Study medication application will be performed by the individual subject at approximately the same time each day.

DRUG

Topical SM04554 solution

Study medication application will be performed by the individual subject at approximately the same time each day.

DRUG

Topical vehicle solution

Vehicle solution application will be performed by the individual subject at approximately the same time each day.

Sponsors & Collaborators

  • Biosplice Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Yusuf Yazici, M.D. · Biosplice Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03742518 on ClinicalTrials.gov