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

Information source: Dong-A ST Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Androgenetic Alopecia

Intervention: DA-4001C (Drug); 5% minoxidil (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Dong-A ST Co., Ltd.

Official(s) and/or principal investigator(s):
Hoon Kang, M.D, Ph.D, Principal Investigator, Affiliation: The catholic univ. of korea, St.Paul's hospital

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

Clinical Details

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

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

Primary outcome: Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram

Secondary outcome:

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

Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram

Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram

Eligibility

Minimum age: 18 Years. Maximum age: 49 Years. Gender(s): Male.

Criteria:

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 and Contacts

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

Starting date: January 2014
Last updated: June 22, 2015

Page last updated: August 23, 2015

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