Clincosm LogoSign in Get a demo

A Study to Evaluate the Efficacy and Safety of AD-208

Sponsor
Addpharma Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04825561
Collaborator
(none)
130
Enrollment
1
Location
3
Arms
17.7
Anticipated Duration (Months)
7.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of AD-208.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

The purpose of this study is to evaluate the efficacy and safety of AD-208 in male patients with androgenetic alopecia.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
130 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of AD-208 in Male Patients With Androgenetic Alopecia
Actual Study Start Date :
Jun 9, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active Comparator

AD-208 and Placebo of AD-2081

Drug: AD-208
PO, Once daily(QD), 24weeks

Drug: placebo of AD-2081
PO, Once daily(QD), 24weeks
Placebo Comparator: Placebo Comparator

Placebo of AD-208 and Placebo of AD-2081

Drug: placebo of AD-208
PO, Once daily(QD), 24weeks

Drug: placebo of AD-2081
PO, Once daily(QD), 24weeks
Experimental: Experimental Comparator

Placebo of AD-208 and AD-2081

Drug: AD-2081
PO, Once daily(QD), 24weeks

Drug: placebo of AD-208
PO, Once daily(QD), 24weeks

Outcome Measures

Primary Outcome Measures

  1. The amount of Change in the total number of hairs [Baseline, Week 24]

    The amount of change in the total number of hairs in the unit area

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Male patients aged 18-50 years, inclusive

  • Patients who meet the appropriate criteria according to the classification of hair loss

  • Signed informed consent

Exclusion Criteria:

  • Patients with hair loss disorders other than androgenetic alopecia

  • Other exclusions applied

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul Korea, Republic of

Sponsors and Collaborators

  • Addpharma Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Addpharma Inc.
ClinicalTrials.gov Identifier:
NCT04825561
Other Study ID Numbers:
  • AD-208P3
First Posted:
Apr 1, 2021
Last Update Posted:
Nov 15, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Alopecia
Alopecia Areata

Study Results

No Results Posted as of Nov 15, 2021