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

NCT ID: NCT02280603

Last Updated: 2015-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DA-4001C

DA-4001C is administered

Group Type EXPERIMENTAL

DA-4001C

Intervention Type DRUG

1ml by topical application twice a day

5% minoxidil

5% minoxidil is administered

Group Type ACTIVE_COMPARATOR

5% minoxidil

Intervention Type DRUG

1ml by topical application twice a day

Interventions

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DA-4001C

1ml by topical application twice a day

Intervention Type DRUG

5% minoxidil

1ml by topical application twice a day

Intervention Type DRUG

Other Intervention Names

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minoxyl

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Dong-A ST Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hoon Kang, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

The catholic univ. of korea, St.Paul's hospital

Locations

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Catholic Medical Center

Seoul, Dongdaemun-gu, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DA4001_AGAP_POC

Identifier Type: -

Identifier Source: org_study_id

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