Assessment of Dutasteride Topical Solution in Male Androgenetic Alopecia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AD-303A, AD-3031.
- Who it may be relevant to
- Registry conditions: Androgenetic Alopecia. Basic parameters: 19 years — 55 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- Drug AD-303A
Topical AD-303A applied to the scalp according to the study protocol. - Drug AD-3031
Oral AD-3031 administered according to the study protocol.
Primary outcome measures
- Maximum observed plasma concentration (Cmax) of dutasteride [Time frame: Up to Day14]
Secondary outcome measures (1)
- Change from baseline in scalp dihydrotestosterone (DHT) concentration Description [Time frame: Baseline to Day 8]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT07490327 · AD-303PK