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

Phase 2

Completed

• Conditions: Androgenetic Alopecia
• Interventions: Drug: CKD-498 dose#2; Drug: CKD-498 dose#3; Drug: CKD-498 dose#1; Drug: Placebo of CKD-498 dose#1; Drug: Placebo of CKD-498 dose#3; Drug: Placebo of CKD-498 dose#2

• Registration Number: NCT05677438
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study Start: 2022-12-20
• Study First Submitted: 2022-12-23
• Study First Submitted QC: 2022-12-23
• Study First Posted: 2023-01-10
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

Inclusion Criteria

• Female of age 19-54 years
• Clinical Diagnosis of Androgenetic Alopecia
• Written informed consent

Key

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group2	CKD-498 dose#2	-
Test Group2	Placebo of CKD-498 dose#1	-
Test Group2	Placebo of CKD-498 dose#3	-
Test Group3	CKD-498 dose#3	-
Test Group3	Placebo of CKD-498 dose#1	-
Test Group3	Placebo of CKD-498 dose#2	-
Test Group1	CKD-498 dose#1	-
Test Group1	Placebo of CKD-498 dose#2	-
Test Group1	Placebo of CKD-498 dose#3	-
Placebo Group	Placebo of CKD-498 dose#1	-
Placebo Group	Placebo of CKD-498 dose#2	-
Placebo Group	Placebo of CKD-498 dose#3	-

Primary Outcome Measures

Name	Time	Method
Total number of hair Changes	Baseline, Week 24	from Baseline at Week24 of total number of hair changes

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Gyeonggi-do, Korea, Republic of