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

Androgenetic Alopecia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677438
• Other study ID #: A128_01AGA2211
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: January 2023
• Source: Chong Kun Dang Pharmaceutical
• Contact: Jiwon Lee, Project Leader
• Phone: +82-2-2194-0470
• Email: jwl[@]ckdpharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 54 Years

Eligibility

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

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Drug:
• CKD-498 dose#1
oral, once daily, 24 weeks
• CKD-498 dose#2
oral, once daily, 24 weeks
• CKD-498 dose#3
oral, once daily, 24 weeks
• Placebo of CKD-498 dose#1
oral, once daily, 24 weeks
• Placebo of CKD-498 dose#2
oral, once daily, 24 weeks
• Placebo of CKD-498 dose#3
oral, once daily, 24 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of hair Changes	from Baseline at Week24 of total number of hair changes	Baseline, Week 24