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
Overview
- Phase
- Phase 2
- Intervention
- CKD-498 dose#1
- Conditions
- Androgenetic Alopecia
- Sponsor
- Chong Kun Dang Pharmaceutical
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- Total number of hair Changes
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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
Detailed Description
Participants were randomly assigned in a 1:1:1:1 ratio to the following group: 3 dose of CKD-498 and Placebo. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 24 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Female of age 19-54 years
- •Clinical Diagnosis of Androgenetic Alopecia
- •Written informed consent
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
Arms & Interventions
Test Group1
Intervention: CKD-498 dose#1
Test Group1
Intervention: Placebo of CKD-498 dose#2
Test Group1
Intervention: Placebo of CKD-498 dose#3
Test Group2
Intervention: CKD-498 dose#2
Test Group2
Intervention: Placebo of CKD-498 dose#1
Test Group2
Intervention: Placebo of CKD-498 dose#3
Test Group3
Intervention: CKD-498 dose#3
Test Group3
Intervention: Placebo of CKD-498 dose#1
Test Group3
Intervention: Placebo of CKD-498 dose#2
Placebo Group
Intervention: Placebo of CKD-498 dose#1
Placebo Group
Intervention: Placebo of CKD-498 dose#2
Placebo Group
Intervention: Placebo of CKD-498 dose#3
Outcomes
Primary Outcomes
Total number of hair Changes
Time Frame: Baseline, Week 24
from Baseline at Week24 of total number of hair changes