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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group1 | Experimental |
| |
| Test Group2 | Experimental |
| |
| Test Group3 | Experimental |
| |
| Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-498 dose#1 | Drug | oral, once daily, 24 weeks |
| |
| CKD-498 dose#2 |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of hair Changes | from Baseline at Week24 of total number of hair changes | Baseline, Week 24 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ChangHun Huh, MD, PhD. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
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| Drug |
oral, once daily, 24 weeks |
|
| CKD-498 dose#3 | Drug | oral, once daily, 24 weeks |
|
| Placebo of CKD-498 dose#1 | Drug | oral, once daily, 24 weeks |
|
| Placebo of CKD-498 dose#2 | Drug | oral, once daily, 24 weeks |
|
| Placebo of CKD-498 dose#3 | Drug | oral, once daily, 24 weeks |
|
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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