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

Dong-A ST Co., Ltd.60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Androgenetic Alopecia

Interventions

DA-4001CDRUG

1ml by topical application twice a day

5% minoxidilDRUG

1ml by topical application twice a day

Eligibility

Sex: MALEMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

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

Locations (1)

Catholic Medical Center

Seoul, Dongdaemun-gu, South Korea

Outcomes

Primary Outcomes

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

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

Time frame: Baseline and week 16

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

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

Data from ClinicalTrials.gov

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