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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05677438
Enrollment
121
Registered
2023-01-10
Start date
2022-12-20
Completion date
2023-12-15
Last updated
2024-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic Alopecia

Keywords

Androgenetic Alopecia, CKD-498

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.

Interventions

DRUGCKD-498 dose#1

oral, once daily, 24 weeks

DRUGCKD-498 dose#2

oral, once daily, 24 weeks

DRUGCKD-498 dose#3

oral, once daily, 24 weeks

DRUGPlacebo of CKD-498 dose#1

oral, once daily, 24 weeks

DRUGPlacebo of CKD-498 dose#2

oral, once daily, 24 weeks

DRUGPlacebo of CKD-498 dose#3

oral, once daily, 24 weeks

Sponsors

Chong Kun Dang Pharmaceutical
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 54 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Total number of hair ChangesBaseline, Week 24from Baseline at Week24 of total number of hair changes

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026