Androgenetic Alopecia
Conditions
Brief summary
This study is designed to explore the efficacy and safety of DA-4001 after topical application in male patients with androgenetic alopecia Design : Randomized, double-blind, active-controlled study Investigational Product : Finasteride, minoxidil
Interventions
DRUGDA-4001C
1ml by topical application twice a day
DRUG5% minoxidil
1ml by topical application twice a day
Sponsors
Dong-A ST Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Basic and specific(BASP) classification : basic type is M2 or C2 and specific type is V1,V2 or F1,F2
Exclusion criteria
* Evidence of hair loss other than androgenetic alopecia * Use of finasteride, dutasteride within previous 12 months * Use of minoxidil within previous 6 months * Use of androgenic or anti-androgenic agents within previous 6 months * Use of steroid agents for local application to scalp or systemic application within previous 1 month * History of hair transplantation, scalp reduction * Coronary artery disease, arrhythmia, congestive heart failure, valvular haert disease, angina pectoris
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram | baseline and week 24 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram | Baseline and week 16 |
| Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram | Baseline, week 16,and week24 |
| Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram | Baseline, week 16, and week 24 |
Countries
South Korea
Outcome results
None listed