Clinical Trial to Explore the Efficacy and Safety of DA-4... | NCT02280603

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

NCT02280603

Sponsor

Dong-A ST Co., Ltd.

Status

Completed

Last Update Posted

Jun 24, 2015Estimated

Enrollment

60Actual

Phase

Phase 1Phase 2

Conditions

Androgenetic Alopecia

Interventions

DA-4001C
5% minoxidil

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Oct 29, 2014

First Submission Date that Met QC Criteria

Oct 29, 2014

First Posted Date

Oct 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2015

Last Update Posted Date

Jun 24, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DA-4001C	Experimental	DA-4001C is administered	Drug: DA-4001C
5% minoxidil	Active Comparator	5% minoxidil is administered	Drug: 5% minoxidil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-4001C	Drug	1ml by topical application twice a day	DA-4001C
5% minoxidil

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram		baseline and week 24

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hoon Kang, M.D, Ph.D	The catholic univ. of korea, St.Paul's hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Catholic Medical Center		Seoul	Dongdaemun-gu	130-709	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D000505	Alopecia

Ancestor Terms

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008914	Minoxidil

Ancestor Terms

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011743	Pyrimidines

Browse Leaves

Not provided

Browse Branches

Not provided