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
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
Treatments tested in this trial
- AD-303A
- AD-3031
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Moogene Medi Co., Ltd
Lead sponsor
Seoul National University Hospital
Collaborator
Source ClinicalTrials.gov