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Completed

NCT Number: NCT05677438

A Phase 2 Study to Evaluate the Safety and Efficacy 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

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–54 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital

Gyeonggi-do, 13620, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CKD-498 dose#1

Drug

oral, once daily, 24 weeks

CKD-498 dose#2

Drug

oral, once daily, 24 weeks

CKD-498 dose#3

Drug

oral, once daily, 24 weeks

Placebo of CKD-498 dose#1

Drug

oral, once daily, 24 weeks

Placebo of CKD-498 dose#2

Drug

oral, once daily, 24 weeks

Placebo of CKD-498 dose#3

Drug

oral, once daily, 24 weeks

Primary outcomes

  1. Total number of hair Changes

    Time frame: Baseline, Week 24

    from Baseline at Week24 of total number of hair changes

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2023
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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