Back to resultsClinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application
Primary Purpose
Androgenetic Alopecia
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-4001C
5% minoxidil
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia
Eligibility 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
Sites / Locations
- Catholic Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
DA-4001C
5% minoxidil
Arm Description
DA-4001C is administered
5% minoxidil is administered
Outcomes
Primary Outcome Measures
Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02280603
Brief Title
Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application
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 Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A ST Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DA-4001C
Arm Type
Experimental
Arm Description
DA-4001C is administered
Arm Title
5% minoxidil
Arm Type
Active Comparator
Arm Description
5% minoxidil is administered
Intervention Type
Drug
Intervention Name(s)
DA-4001C
Intervention Description
1ml by topical application twice a day
Intervention Type
Drug
Intervention Name(s)
5% minoxidil
Other Intervention Name(s)
minoxyl
Intervention Description
1ml by topical application twice a day
Primary Outcome Measure Information:
Title
Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram
Time Frame
baseline and week 24
Secondary Outcome Measure Information:
Title
Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram
Time Frame
Baseline and week 16
Title
Improvement rate of target area hair count per cm2 at week 16 and week 24, as assessed by phototrichogram
Time Frame
Baseline, week 16,and week24
Title
Improvement rate of target area mean hair diameter at week 16 and week 24, as assessed by phototrichogram
Time Frame
Baseline, week 16, and week 24
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hoon Kang, M.D, Ph.D
Organizational Affiliation
The catholic univ. of korea, St.Paul's hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic Medical Center
City
Seoul
State/Province
Dongdaemun-gu
ZIP/Postal Code
130-709
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial to Explore the Efficacy and Safety of DA-4001 After Topical Application
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