NCT04825561

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 1, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

June 9, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

July 21, 2023

Status Verified

July 1, 2023

Enrollment Period

1.6 years

First QC Date

March 29, 2021

Last Update Submit

July 19, 2023

Conditions

Androgenetic Alopecia

Outcome Measures

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

    Baseline, Week 24

Study Arms (3)

Active Comparator

ACTIVE COMPARATOR

AD-208 and Placebo of AD-2081

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

Placebo Comparator

PLACEBO COMPARATOR

Placebo of AD-208 and Placebo of AD-2081

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

Experimental Comparator

EXPERIMENTAL

Placebo of AD-208 and AD-2081

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

Interventions

AD-208DRUG

PO, Once daily(QD), 24weeks

Active Comparator
AD-2081DRUG

PO, Once daily(QD), 24weeks

Experimental Comparator
placebo of AD-208DRUG

PO, Once daily(QD), 24weeks

Experimental ComparatorPlacebo Comparator
placebo of AD-2081DRUG

PO, Once daily(QD), 24weeks

Active ComparatorPlacebo Comparator

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male patients aged 18-50 years, inclusive
  • Patients who meet the appropriate criteria according to the classification of hair loss
  • Signed informed consent

You may not qualify if:

  • Patients with hair loss disorders other than androgenetic alopecia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 40736519DERIVED

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2021

First Posted

April 1, 2021

Study Start

June 9, 2021

Primary Completion

January 9, 2023

Study Completion

June 1, 2023

Last Updated

July 21, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)