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

June 27, 2024 updated by: Chong Kun Dang Pharmaceutical

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

121

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chong Kun Dang Pharmaceutical

Investigators

  • Principal Investigator: ChangHun Huh, MD, PhD., Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2022

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

December 15, 2023

Study Registration Dates

First Submitted

December 23, 2022

First Submitted That Met QC Criteria

December 23, 2022

First Posted (Actual)

January 10, 2023

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A128_01AGA2211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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