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

Phase 1

Completed

• Conditions: Androgenetic Alopecia
• Interventions: Drug: DA-4001C; Drug: 5% minoxidil

• Registration Number: NCT02280603
• Lead Sponsor: Dong-A ST Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-31
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-22
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-4001C	DA-4001C	DA-4001C is administered
5% minoxidil	5% minoxidil	5% minoxidil is administered

Primary Outcome Measures

Name	Time	Method
Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram	baseline and week 24

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Catholic Medical Center; 🇰🇷 Seoul, Dongdaemun-gu, Korea, Republic of