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

Phase 3

Completed

• Conditions: Androgenetic Alopecia
• Interventions: Drug: placebo of AD-208; Drug: AD-208; Drug: AD-2081; Drug: placebo of AD-2081

• Registration Number: NCT04825561
• Lead Sponsor: Addpharma Inc.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-06-09
• Primary Completion: 2023-01-09
• Study Completion: 2023-06-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-19
• Last Update Posted: 2023-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 139

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

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Exclusion Criteria

• Patients with hair loss disorders other than androgenetic alopecia
• Other exclusions applied

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	placebo of AD-208	Placebo of AD-208 and Placebo of AD-2081
Active Comparator	AD-208	AD-208 and Placebo of AD-2081
Experimental Comparator	placebo of AD-208	Placebo of AD-208 and AD-2081
Active Comparator	placebo of AD-2081	AD-208 and Placebo of AD-2081
Experimental Comparator	AD-2081	Placebo of AD-208 and AD-2081
Placebo Comparator	placebo of AD-2081	Placebo of AD-208 and Placebo of AD-2081

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Catholic University of Korea, Eunpyeong St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of