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Completed

NCT Number: NCT02280603

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

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

Completed

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–49 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Catholic Medical Center

Seoul, Dongdaemun-gu, 130-709, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DA-4001C

Drug

1ml by topical application twice a day

5% Minoxidil

Drug

1ml by topical application twice a day

Other names: minoxyl

Primary outcomes

  1. Change from baseline in target area hair count per cm2 at week 24, as assessed by phototrichogram

    Time frame: baseline and week 24

Secondary outcomes

  1. Change from baseline in target area hair count per cm2 at week 16, as assessed by phototrichogram

    Time frame: Baseline and week 16

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Dong-A ST Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 31, 2014
Registry last updated
Jun 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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