A Phase 2, Randomized, Double-blind, Multi-center, Parallel-group Trial to Evaluate the Efficacy and Safety of CKD-498 in Female Patients With Androgenetic Alopecia

A128_01AGA2211

This is a multi-centers, randomized, double-blind, parallel-group, Phase 2 Trial to evaluate the efficacy and safety of CKD-498 in female patients with Androgenetic Alopecia

2022-12-20

2024-04-30

2024-04-30

Recruiting

Early phase I

120

Key Inclusion Criteria: * Female of age 19-54 years * Clinical Diagnosis of Androgenetic Alopecia * Written informed consent Key Exclusion Criteria: * Other types of Alopecia or other diseases that can cause hair loss * Clinically significant scalp disease such as seborrheic dermatitis or psoriasis * Clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the Investigator * Women who are pregnant or breastfeeding * Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2023-01-12