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

Dong-A ST

Status and phase: Completed; Phase 2; Phase 1

Conditions: Androgenetic Alopecia

Treatments: Drug: 5% minoxidil; Drug: DA-4001C

Study type: Interventional

Funder types: Industry

Identifiers

NCT02280603

DA4001_AGAP_POC

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: Male

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups

DA-4001C

Experimental group

Description:

DA-4001C is administered

Treatment:

Drug: DA-4001C

5% minoxidil

Active Comparator group

Description:

5% minoxidil is administered

Treatment:

Drug: 5% minoxidil