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A 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
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Androgenetic Alopecia focused on measuring Androgenetic Alopecia, CKD-498

Eligibility Criteria

19 Years - 54 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
December 23, 2022
Last Updated
January 10, 2023
Sponsor
Chong Kun Dang Pharmaceutical
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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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