Back to resultsA Study to Evaluate the Efficacy and Safety of AD-208
Primary Purpose
Androgenetic Alopecia
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
AD-208
AD-2081
placebo of AD-208
placebo of AD-2081
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia
Eligibility Criteria
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
Sites / Locations
- The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Experimental
Arm Label
Active Comparator
Placebo Comparator
Experimental Comparator
Arm Description
AD-208 and Placebo of AD-2081
Placebo of AD-208 and Placebo of AD-2081
Placebo of AD-208 and AD-2081
Outcomes
Primary Outcome Measures
The amount of Change in the total number of hairs
The amount of change in the total number of hairs in the unit area
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04825561
Brief Title
A Study to Evaluate the Efficacy and Safety of AD-208
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2021 (Actual)
Primary Completion Date
January 9, 2023 (Actual)
Study Completion Date
June 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Addpharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
AD-208 and Placebo of AD-2081
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo of AD-208 and Placebo of AD-2081
Arm Title
Experimental Comparator
Arm Type
Experimental
Arm Description
Placebo of AD-208 and AD-2081
Intervention Type
Drug
Intervention Name(s)
AD-208
Intervention Description
PO, Once daily(QD), 24weeks
Intervention Type
Drug
Intervention Name(s)
AD-2081
Intervention Description
PO, Once daily(QD), 24weeks
Intervention Type
Drug
Intervention Name(s)
placebo of AD-208
Intervention Description
PO, Once daily(QD), 24weeks
Intervention Type
Drug
Intervention Name(s)
placebo of AD-2081
Intervention Description
PO, Once daily(QD), 24weeks
Primary Outcome Measure Information:
Title
The amount of Change in the total number of hairs
Description
The amount of change in the total number of hairs in the unit area
Time Frame
Baseline, Week 24
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of AD-208
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