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This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male patients with Androgenetic Alopecia
The participants were randomly assigned to one of the following groups: CKD-843 dose #1, CKD-843 dose #2, placebo, or Dutasteride group. They received the assigned medication, placebo for blinding, or the reference drug over a 12-month period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group1 | Experimental | CKD-843 dose#1 + Placebo of Dutasteride Capsule |
|
| Test Group2 | Experimental | CKD-843 dose#2 + Placebo of Dutasteride Capsule |
|
| Placebo-controlled Group | Placebo Comparator | Placebo of CKD-843 dose + Placebo of Dutasteride Capsule |
|
| Active-controlled Group | Active Comparator | Placebo of CKD-843 dose + Dutasteride Capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CKD-843 dose#1 | Drug | IM injection every 3 months for 12 months |
| |
| 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 | Role | Phone | Extension | |
|---|---|---|---|---|
| OhSang Kwon, MD, PhD | Contact | +2-2072-2417 | oskwon@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| OhSang Kwon, MD, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| CKD-843 dose#2 |
| Drug |
IM injection every 3 months for 12 months |
|
| Placebo of CKD-843 dose | Drug | IM injection every 3 months for 12 months |
|
| Dutasteride Capsules | Drug | oral, once daily, 12 months |
|
| Placebo of Dutasteride Capsule | Drug | oral, once daily, 12 months |
|
| 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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| ID | Term |
|---|---|
| D000068538 | Dutasteride |
| ID | Term |
|---|---|
| D001378 | Azasteroids |
| D013260 | Steroids, Heterocyclic |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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