Assessment of Dutasteride Topical Solution in Male Androgenetic Alopecia

ConditionAndrogenetic Alopecia

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexMale

Age19-55

SponsorMoogene Medi Co., Ltd

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: AD-303A TopicalExperimental treatment 1 intervention

Group B: Oral AD-3031Active comparator 1 intervention

Trial outcomes

Primary outcomes

Maximum observed plasma concentration (Cmax) of dutasteride

The maximum observed plasma concentration (Cmax) of dutasteride following administration of the study drug.

Time frame

Up to Day14

Secondary outcomes

Change from baseline in scalp dihydrotestosterone (DHT) concentration Description

Change from baseline in scalp tissue dihydrotestosterone (DHT) concentration measured following repeated administration of topical dutasteride.

Time frame

Baseline to Day 8

Sponsors and contacts

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Moogene Medi Co., Ltd

Lead sponsor

Seoul National University Hospital

Collaborator

Source ClinicalTrials.gov

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