A Phase 3 Study to Evaluate the Safety and Efficacy of CKD-843 in Male Patients With Androgenetic Alopecia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CKD-843 dose#1, CKD-843 dose#2, Placebo of CKD-843 dose, Dutasteride Capsules.
- Who it may be relevant to
- Registry conditions: Androgenetic Alopecia. Basic parameters: 18 years — 50 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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.
Interventions
- Drug CKD-843 dose#1
IM injection every 3 months for 12 months - Drug CKD-843 dose#2
IM injection every 3 months for 12 months - Drug Placebo of CKD-843 dose
IM injection every 3 months for 12 months - Drug Dutasteride Capsules
oral, once daily, 12 months - Drug Placebo of Dutasteride Capsule
oral, once daily, 12 months
Primary outcome measures
- Total number of hair Changes [Time frame: Baseline, Week 24]
Eligibility criteria
Inclusion criteria
- Male of age 18-50 years
- Clinical Diagnosis of Androgenetic Alopecia
- Written informed consent
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT06916793 · A107_03AGA2318