Androgenetic Alopecia
Conditions
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.
Interventions
DRUGCKD-843 dose#1
IM injection every 3 months for 12 months
DRUGCKD-843 dose#2
IM injection every 3 months for 12 months
DRUGPlacebo of CKD-843 dose
IM injection every 3 months for 12 months
oral, once daily, 12 months
DRUGPlacebo of Dutasteride Capsule
oral, once daily, 12 months
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of hair Changes | Baseline, Week 24 | from Baseline at Week24 of total number of hair changes |
Countries
South Korea
Contacts
CONTACTOhSang Kwon, MD, PhD
PRINCIPAL_INVESTIGATOROhSang Kwon, MD, PhD
Seoul National University Hospital
Outcome results
None listed