Assessment of Dutasteride Topical Solution in Male Androgenetic Alopecia

March 19, 2026 updated by: Moogene Medi Co., Ltd

A Randomized, Open-label, Single and Multiple-dose, Parallel-design Phase 1/2a Clinical Trial to Evaluate the Pharmacokinetics/Pharmacodynamics and Safety of AD-303A and Oral Administration of AD-3031 in Male Androgenetic Alopecia Patients

This is a randomized, open-label phase 1/2a study designed to evaluate the pharmacokinetics, pharmacodynamics, and safety of AD-303A (topical formulation) and AD-3031 in male patients with androgenetic alopecia. The study aims to compare pharmacological characteristics and safety profiles to support dose selection for further clinical development.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2
  • Phase 1

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 Contact Backup

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Seoul National University Hospital
        • Contact:

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

Yes

Description

Inclusion Criteria:

  • Male participants aged 19 to 55 years.
  • Clinical diagnosis of androgenetic alopecia.
  • Healthy as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests.
  • Willing and able to comply with all study procedures and visit schedules.

Exclusion Criteria:

  • History or presence of dermatologic conditions affecting the scalp other than androgenetic alopecia.
  • Prior hair transplantation or scalp surgery that may affect evaluation of hair growth.
  • Use of medications known to affect hair growth (e.g., finasteride, dutasteride, minoxidil) within 6 months prior to screening.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AD-303A Topical
Participants receive topical AD-303A applied to the scalp according to the study protocol.
Drug: AD-303A
Topical AD-303A applied to the scalp according to the study protocol.
Active Comparator: Oral AD-3031
Participants receive oral AD-3031 administered according to the study protocol.
Drug: AD-3031
Oral AD-3031 administered according to the study protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum observed plasma concentration (Cmax) of dutasteride
Time Frame: Up to Day14
The maximum observed plasma concentration (Cmax) of dutasteride following administration of the study drug.
Up to Day14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in scalp dihydrotestosterone (DHT) concentration Description
Time Frame: Baseline to Day 8
Change from baseline in scalp tissue dihydrotestosterone (DHT) concentration measured following repeated administration of topical dutasteride.
Baseline to Day 8

Collaborators and Investigators

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

Sponsor

Moogene Medi Co., Ltd

Collaborators

Seoul National University Hospital

Investigators

  • Principal Investigator: Seung Hwan Lee, Ph.D., Seoul National University Hospital

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)

April 1, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-303PK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Phase 1/2a

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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