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

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280603
• Other study ID #: DA4001_AGAP_POC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 29, 2014
• Last updated: June 22, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: June 2015
• Source: Dong-A ST Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

Drug:
• DA-4001C
1ml by topical application twice a day
• 5% minoxidil
1ml by topical application twice a day

Locations

Country	Name	City	State
Korea, Republic of	Catholic Medical Center	Seoul	Dongdaemun-gu

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A ST Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram		baseline and week 24	No
Secondary	Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram		Baseline and week 16	No
Secondary	Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram		Baseline, week 16,and week24	No
Secondary	Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram		Baseline, week 16, and week 24	No