A Phase 2 Study to Evaluate the Safety and Efficacy of CKD-498 in Female Patients With Androgenetic Alopecia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Androgenetic Alopecia

Intervention / Treatment
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* Drug: CKD-498 dose#1
* Drug: CKD-498 dose#2
* Drug: CKD-498 dose#3
* Drug: Placebo of CKD-498 dose#1
* Drug: Placebo of CKD-498 dose#2
* Drug: Placebo of CKD-498 dose#3


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Group1<br> | Drug: CKD-498 dose#1<br>* oral, once daily, 24 weeks<br>Drug: Placebo of CKD-498 dose#2<br>* oral, once daily, 24 weeks<br>Drug: Placebo of CKD-498 dose#3<br>* oral, once daily, 24 weeks<br>|
| Experimental: Test Group2<br> | Drug: CKD-498 dose#2<br>* oral, once daily, 24 weeks<br>Drug: Placebo of CKD-498 dose#1<br>* oral, once daily, 24 weeks<br>Drug: Placebo of CKD-498 dose#3<br>* oral, once daily, 24 weeks<br>|
| Experimental: Test Group3<br> | Drug: CKD-498 dose#3<br>* oral, once daily, 24 weeks<br>Drug: Placebo of CKD-498 dose#1<br>* oral, once daily, 24 weeks<br>Drug: Placebo of CKD-498 dose#2<br>* oral, once daily, 24 weeks<br>|
| Placebo Comparator: Placebo Group<br> | Drug: Placebo of CKD-498 dose#1<br>* oral, once daily, 24 weeks<br>Drug: Placebo of CKD-498 dose#2<br>* oral, once daily, 24 weeks<br>Drug: Placebo of CKD-498 dose#3<br>* oral, once daily, 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of hair Changes | from Baseline at Week24 of total number of hair changes | Baseline, Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Androgenetic Alopecia, CKD-498