Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application
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
1 other identifier
interventional
60
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 24, 2015
June 1, 2015
11 months
October 29, 2014
June 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram
baseline and week 24
Secondary Outcomes (3)
Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram
Baseline and week 16
Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram
Baseline, week 16,and week24
Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram
Baseline, week 16, and week 24
Study Arms (2)
DA-4001C
EXPERIMENTALDA-4001C is administered
5% minoxidil
ACTIVE COMPARATOR5% minoxidil is administered
Interventions
Eligibility Criteria
You may qualify if:
- Basic and specific(BASP) classification : basic type is M2 or C2 and specific type is V1,V2 or F1,F2
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Catholic Medical Center
Seoul, Dongdaemun-gu, 130-709, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hoon Kang, M.D, Ph.D
The catholic univ. of korea, St.Paul's hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2014
First Posted
October 31, 2014
Study Start
January 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
June 24, 2015
Record last verified: 2015-06