Assessment of Dutasteride Topical Solution in Male Androgenetic Alopecia

Moogene Medi Co., Ltd

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Androgenetic Alopecia

Treatments: Drug: AD-303A; Drug: AD-3031

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07490327

AD-303PK

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Male

Ages: 19 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

AD-303A Topical

Experimental group

Description:

Participants receive topical AD-303A applied to the scalp according to the study protocol.

Treatment:

Drug: AD-303A

Oral AD-3031

Active Comparator group

Description:

Participants receive oral AD-3031 administered according to the study protocol.

Treatment:

Drug: AD-3031