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

Phase 3

Not yet recruiting

• Conditions: Androgenetic Alopecia
• Interventions: Drug: CKD-843 dose#1; Drug: CKD-843 dose#2; Drug: Placebo of CKD-843 dose; Drug: Placebo of Dutasteride Capsule; Drug: Dutasteride Capsules

• Registration Number: NCT06916793
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-01
• Study First Submitted QC: 2025-04-01
• Last Update Submitted: 2025-04-01
• Study First Posted: 2025-04-08
• Last Update Posted: 2025-04-08
• Study Start: 2025-04-30
• Primary Completion: 2026-12-19
• Study Completion: 2027-09-17

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 288

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Group1	CKD-843 dose#1	CKD-843 dose#1 + Placebo of Dutasteride Capsule
Test Group1	Placebo of Dutasteride Capsule	CKD-843 dose#1 + Placebo of Dutasteride Capsule
Test Group2	CKD-843 dose#2	CKD-843 dose#2 + Placebo of Dutasteride Capsule
Test Group2	Placebo of Dutasteride Capsule	CKD-843 dose#2 + Placebo of Dutasteride Capsule
Placebo-controlled Group	Placebo of CKD-843 dose	Placebo of CKD-843 dose + Placebo of Dutasteride Capsule
Placebo-controlled Group	Placebo of Dutasteride Capsule	Placebo of CKD-843 dose + Placebo of Dutasteride Capsule
Active-controlled Group	Placebo of CKD-843 dose	Placebo of CKD-843 dose + Dutasteride Capsules
Active-controlled Group	Dutasteride Capsules	Placebo of CKD-843 dose + Dutasteride Capsules

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 Hospital; 🇰🇷 Seoul, Korea, Republic of