Back to resultsA Phase 2 Study to Evaluate the Safety and Efficacy of CKD-498 in Female Patients With Androgenetic Alopecia
Primary Purpose
Androgenetic Alopecia
Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CKD-498 dose#1
CKD-498 dose#2
CKD-498 dose#3
Placebo of CKD-498 dose#1
Placebo of CKD-498 dose#2
Placebo of CKD-498 dose#3
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Androgenetic Alopecia, CKD-498
Eligibility Criteria
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
Sites / Locations
- Seoul National University Bundang HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Test Group1
Test Group2
Test Group3
Placebo Group
Arm Description
Outcomes
Primary Outcome Measures
Total number of hair Changes
from Baseline at Week24 of total number of hair changes
Secondary Outcome Measures
Full Information
NCT ID
NCT05677438
First Posted
December 23, 2022
Last Updated
January 10, 2023
Sponsor
Chong Kun Dang Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT05677438
Brief Title
A Phase 2 Study to Evaluate the Safety and Efficacy of CKD-498 in Female Patients With Androgenetic Alopecia
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
Keywords
Androgenetic Alopecia, CKD-498
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Group1
Arm Type
Experimental
Arm Title
Test Group2
Arm Type
Experimental
Arm Title
Test Group3
Arm Type
Experimental
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CKD-498 dose#1
Intervention Description
oral, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
CKD-498 dose#2
Intervention Description
oral, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
CKD-498 dose#3
Intervention Description
oral, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo of CKD-498 dose#1
Intervention Description
oral, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo of CKD-498 dose#2
Intervention Description
oral, once daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo of CKD-498 dose#3
Intervention Description
oral, once daily, 24 weeks
Primary Outcome Measure Information:
Title
Total number of hair Changes
Description
from Baseline at Week24 of total number of hair changes
Time Frame
Baseline, Week 24
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiwon Lee, Project Leader
Phone
+82-2-2194-0470
Email
jwl@ckdpharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ChangHun Huh, MD, PhD.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ChangHun Huh, MD, PhD,
Phone
+82-31-787-7313
Email
chhuh@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
ChangHun Huh, MD, PhD,
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase 2 Study to Evaluate the Safety and Efficacy of CKD-498 in Female Patients With Androgenetic Alopecia
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