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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02280603
First Posted: October 31, 2014
Last Update Posted: June 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dong-A ST Co., Ltd.
  Purpose

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


Condition Intervention Phase
Androgenetic Alopecia Drug: DA-4001C Drug: 5% minoxidil Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dong-A ST Co., Ltd.:

Primary Outcome Measures:
  • 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 Measures:
  • Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram [ Time Frame: Baseline and week 16 ]
  • 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 ]
  • 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 ]

Enrollment: 60
Study Start Date: January 2014
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DA-4001C
DA-4001C is administered
Drug: DA-4001C
1ml by topical application twice a day
Active Comparator: 5% minoxidil
5% minoxidil is administered
Drug: 5% minoxidil
1ml by topical application twice a day
Other Name: minoxyl

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280603


Locations
Korea, Republic of
Catholic Medical Center
Seoul, Dongdaemun-gu, Korea, Republic of, 130-709
Sponsors and Collaborators
Dong-A ST Co., Ltd.
Investigators
Principal Investigator: Hoon Kang, M.D, Ph.D The catholic univ. of korea, St.Paul's hospital
  More Information

Responsible Party: Dong-A ST Co., Ltd.
ClinicalTrials.gov Identifier: NCT02280603     History of Changes
Other Study ID Numbers: DA4001_AGAP_POC
First Submitted: October 29, 2014
First Posted: October 31, 2014
Last Update Posted: June 24, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Minoxidil
Antihypertensive Agents
Vasodilator Agents