Assessment of Dutasteride Topical Solution in Male Androgenetic Alopecia

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

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07490327

Enrollment

Registered

2026-03-24

Start date

2026-04-01

Completion date

2026-12-01

Last updated

2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic Alopecia

Keywords

AD-303A / AD-3031, Androgenetic Alopecia, Dutasteride, Topical, 5-Alpha Reductase Inhibitor, Pharmacokinetics, Safety

Brief summary

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.

Interventions

DRUGAD-303A

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

DRUGAD-3031

Oral AD-3031 administered according to the study protocol.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Allocation, Randomized, Open label

Intervention model description

Arm1 : Topical AD-303A applied to the scalp according to the study dosing schedule. Arm 2: Oral AD-3031 administered according to the study dosing schedule.

Eligibility

Sex/Gender

MALE

Age

19 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

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

Countries

South Korea

Contacts

CONTACTJi-Hye Lee, Ph.D.

jhlee@moogene.com82-31-8027-6150

CONTACTTae-Jong Yoon, Ph.D.

moogenemedi@moogene.com82-31-8027-6150

PRINCIPAL_INVESTIGATORSeung Hwan Lee, Ph.D.

Seoul National University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026