A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AD-208 in Male Patients With Androgenetic Alopecia
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Addpharma Inc.
- Enrollment
- 139
- Locations
- 1
- Primary Endpoint
- The amount of Change in the total number of hairs
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of AD-208.
Detailed Description
The purpose of this study is to evaluate the efficacy and safety of AD-208 in male patients with androgenetic alopecia.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male patients aged 18-50 years, inclusive
- •Patients who meet the appropriate criteria according to the classification of hair loss
- •Signed informed consent
Exclusion Criteria
- •Patients with hair loss disorders other than androgenetic alopecia
- •Other exclusions applied
Arms & Interventions
Active Comparator
AD-208 and Placebo of AD-2081
Intervention: AD-208 (Drug)
Active Comparator
AD-208 and Placebo of AD-2081
Intervention: placebo of AD-2081 (Drug)
Placebo Comparator
Placebo of AD-208 and Placebo of AD-2081
Intervention: placebo of AD-208 (Drug)
Placebo Comparator
Placebo of AD-208 and Placebo of AD-2081
Intervention: placebo of AD-2081 (Drug)
Experimental Comparator
Placebo of AD-208 and AD-2081
Intervention: AD-2081 (Drug)
Experimental Comparator
Placebo of AD-208 and AD-2081
Intervention: placebo of AD-208 (Drug)
Outcomes
Primary Outcomes
The amount of Change in the total number of hairs
Time Frame: Baseline, Week 24
The amount of change in the total number of hairs in the unit area
Secondary Outcomes
No secondary outcomes reported