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NCT Number: NCT06916793

A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia

This is a multi-centers, randomized, double-blind, parallel-group, Phase 3 Trial to evaluate the efficacy and safety of CKD-843 in Male 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

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

About this study

The participants were randomly assigned to one of the following groups: CKD-843 dose #1, CKD-843 dose #2, placebo, or Dutasteride group. They received the assigned medication, placebo for blinding, or the reference drug over a 12-month period.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Male of age 18-50 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
  • Participants who do not agree to use contraception during the trial and for 24 weeks after the last dose, and plan to provide sperm or conceive within 24 weeks after the last dose

Treatment and study plan

CKD-843 dose#1

Drug

IM injection every 3 months for 12 months

CKD-843 dose#2

Drug

IM injection every 3 months for 12 months

Placebo of CKD-843 dose

Drug

IM injection every 3 months for 12 months

Dutasteride Capsules

Drug

oral, once daily, 12 months

Placebo of Dutasteride Capsule

Drug

oral, once daily, 12 months

Primary outcomes

  1. Total number of hair Changes

    Time frame: Baseline, Week 24

    from Baseline at Week24 of total number of hair changes

Study contacts

Contact information is provided by the study sponsor or research team.

OhSang Kwon, MD, PhD

CONTACT

[email protected]

+2-2072-2417

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-843 in Male Patients With Androgenetic Alopecia

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 8, 2025
Registry last updated
Apr 8, 2025

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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