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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02280603
Other study ID # DA4001_AGAP_POC
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received October 29, 2014
Last updated June 22, 2015
Start date January 2014
Est. completion date December 2014

Study information

Verified date June 2015
Source Dong-A ST Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 49 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
DA-4001C
1ml by topical application twice a day
5% minoxidil
1ml by topical application twice a day

Locations

Country Name City State
Korea, Republic of Catholic Medical Center Seoul Dongdaemun-gu

Sponsors (1)

Lead Sponsor Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram baseline and week 24 No
Secondary Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram Baseline and week 16 No
Secondary Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram Baseline, week 16,and week24 No
Secondary Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram Baseline, week 16, and week 24 No
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