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

A Single-center, Active-controlled, Randomized, Double-blind, Proof of Concept Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application in Male Patients With Androgenetic Alopecia

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

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Drug: DA-4001C; Drug: 5% minoxidil

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DA-4001C; DA-4001C is administered	Drug: DA-4001C; 1ml by topical application twice a day
Active Comparator: 5% minoxidil; 5% minoxidil is administered	Drug: 5% minoxidil; 1ml by topical application twice a day; Other Names: minoxyl

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Dong-A ST Co., Ltd.
• Investigators: Principal Investigator: Hoon Kang, M.D, Ph.D, The catholic univ. of korea, St.Paul's hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 29, 2014
• First Submitted That Met QC Criteria: October 29, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Estimate): June 24, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: DA4001_AGAP_POC