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CompletedNCT04825561Updated Jul 21, 2023

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

A Phase 3 interventional study of AD-208 and AD-2081 in Androgenetic Alopecia, sponsored by Addpharma Inc.. Completed at 1 site in South Korea. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2023-07-21.

Sponsored by Addpharma Inc. (part of Yuhan Corporation) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
139
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Androgenetic Alopecia

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03

In context

Alopecia

615 studies on the registry are indexed under Alopecia; 132 are open to participants now.

This study's enrollment of 139 is above the median of 45 across 516 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

Addpharma Inc. is the lead sponsor of 58 studies on the registry; 25 are open to participants now.

First submitted after Addpharma Inc. became part of Yuhan Corporation.

Browse Addpharma Inc. studies →All Yuhan Corporation studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with hair loss disorders other than androgenetic alopecia
  • Other exclusions applied
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
139 participants (actual)

Study arms

  • Active comparator
    Active Comparator

    AD-208 and Placebo of AD-2081

    Drug: AD-208 · Drug: placebo of AD-2081

  • Placebo comparator
    Placebo Comparator

    Placebo of AD-208 and Placebo of AD-2081

    Drug: placebo of AD-208 · Drug: placebo of AD-2081

  • Experimental
    Experimental Comparator

    Placebo of AD-208 and AD-2081

    Drug: AD-2081 · Drug: placebo of AD-208

Interventions

  • DrugAD-208

    PO, Once daily(QD), 24weeks

  • DrugAD-2081

    PO, Once daily(QD), 24weeks

  • Drugplacebo of AD-208

    PO, Once daily(QD), 24weeks

  • Drugplacebo of AD-2081

    PO, Once daily(QD), 24weeks

06

What researchers measure

Primary outcomes

  1. The amount of Change in the total number of hairs

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

    Time frame: Baseline, Week 24

07

Study locations

1 site
  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
    Seoul, South Korea
08

References and documents

Publications

  • Lee S, Kim JE, Lew BL, Huh CH, Kim J, Kwon O, Kim MB, Lee YW, Lee Y, Park J, Kim S, Kim DY, Choi GS, Kang H. Efficacy and Safety of Low-Dose (0.2 mg) Dutasteride for Male Androgenic Alopecia: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Trial. Ann Dermatol. 2025 Aug;37(4):183-190. doi: 10.5021/ad.25.048. PubMed 40736519 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04825561
Lead sponsor
Addpharma Inc.
Responsible party
Sponsor
First posted
Apr 1, 2021
Start date
Jun 9, 2021
Primary completion
Jan 9, 2023
Completion
Jun 1, 2023
Last update
Jul 21, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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