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 phototrichogramImprovement 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
|