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CompletedNCT02280603Updated Jun 24, 2015

Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application

A Phase 1/2 interventional study of DA-4001C and 5% minoxidil in Androgenetic Alopecia, sponsored by Dong-A ST Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to male participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2015-06-24.

Sponsored by Dong-A ST Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Androgenetic Alopecia
03

In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's enrollment of 60 is above the median of 45 across 513 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Dong-A ST Co., Ltd. is the lead sponsor of 122 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
Male
Accepts 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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    DA-4001C

    DA-4001C is administered

    Drug: DA-4001C

  • Active comparator
    5% minoxidil

    5% minoxidil is administered

    Drug: 5% minoxidil

Interventions

  • DrugDA-4001C

    1ml by topical application twice a day

  • Drug5% minoxidil

    1ml by topical application twice a day

    Also known as: minoxyl

06

What researchers measure

Primary outcomes

  1. Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram

    Time frame: baseline and week 24

Secondary outcomes

  1. Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram

    Time frame: Baseline and week 16

  2. Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram

    Time frame: Baseline, week 16,and week24

  3. Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram

    Time frame: Baseline, week 16, and week 24

07

Study locations

1 site
  • Catholic Medical Center
    Seoul, Dongdaemun-gu 130-709, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02280603
Lead sponsor
Dong-A ST Co., Ltd.
Responsible party
Sponsor
First posted
Oct 31, 2014
Start date
Jan 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jun 24, 2015

Study contacts

Hoon Kang, M.D, Ph.D
principal investigator · The catholic univ. of korea, St.Paul's hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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