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NCT Number: NCT07490327

Assessment of Dutasteride Topical Solution in Male Androgenetic Alopecia

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.

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Key information

Conditions

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

Age range

19 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

AD-303A

Drug

Topical AD-303A applied to the scalp according to the study protocol.

AD-3031

Drug

Oral AD-3031 administered according to the study protocol.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

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

Ji-Hye Lee, Ph.D.

CONTACT

[email protected]

82-31-8027-6150

Tae-Jong Yoon, Ph.D.

CONTACT

[email protected]

82-31-8027-6150

Sponsors and collaborators

Lead sponsor

Moogene Medi Co., Ltd

Industry

Collaborators

  • Seoul National University Hospital

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Mar 24, 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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