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Clinical trial

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

ID
Name
AD-208P3
Description
The purpose of this study is to evaluate the efficacy and safety of AD-208.
Trial arms
Trial start
2021-06-09
Estimated PCD
2023-01-09
Trial end
2023-06-01
Status
Completed
Phase
Early phase I
Treatment
AD-208
PO, Once daily(QD), 24weeks
Arms:
Active Comparator
AD-2081
PO, Once daily(QD), 24weeks
Arms:
Experimental Comparator
placebo of AD-208
PO, Once daily(QD), 24weeks
Arms:
Experimental Comparator, Placebo Comparator
placebo of AD-2081
PO, Once daily(QD), 24weeks
Arms:
Active Comparator, Placebo Comparator
Size
139
Primary endpoint
The amount of Change in the total number of hairs
Baseline, Week 24
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 139, 'type': 'ACTUAL'}}
Updated at
2023-07-21

1 organization

2 products

1 indication

Organization
Addpharma
Product
AD-208
Indication
Androgenetic Alopecia
Product
AD-2081