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

July 19, 2023 updated by: Addpharma Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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-2081
PO, Once daily(QD), 24weeks
Drug: placebo of AD-208
PO, Once daily(QD), 24weeks
Experimental: Experimental Comparator
Placebo of AD-208 and AD-2081
Drug: placebo of AD-208
PO, Once daily(QD), 24weeks
Drug: AD-2081
PO, Once daily(QD), 24weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The amount of Change in the total number of hairs
Time Frame: Baseline, Week 24
The amount of change in the total number of hairs in the unit area
Baseline, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addpharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2021

Primary Completion (Actual)

January 9, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

July 21, 2023

Last Update Submitted That Met QC Criteria

July 19, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-208P3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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