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NCT04825561 Clinical Trial

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

Androgenetic Alopecia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04825561
Other study ID # AD-208P3
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 9, 2021
Est. completion date June 1, 2023

Study information
Verified date July 2023
Source Addpharma Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 139
Est. completion date June 1, 2023
Est. primary completion date January 9, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 50 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• AD-208
PO, Once daily(QD), 24weeks
• AD-2081
PO, Once daily(QD), 24weeks
• placebo of AD-208
PO, Once daily(QD), 24weeks
• placebo of AD-2081
PO, Once daily(QD), 24weeks

Locations
Country Name City State
Korea, Republic of The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Addpharma Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary The amount of Change in the total number of hairs The amount of change in the total number of hairs in the unit area Baseline, Week 24
See also
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Completed NCT00981461 - Treatment of Androgenetic Alopecia in Females, 9 Beam N/A
Completed NCT01451021 - A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss Phase 2
Completed NCT00151515 - A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss Phase 3
Completed NCT03694067 - Androgenetic Alopecia and the JAK-STAT Pathway
Completed NCT03689452 - The Effect of Platelet Rich Plasma on Non-scarring Alopecia N/A