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

NCT ID: NCT04825561

Last Updated: 2023-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-09

Study Completion Date

2023-06-01

Brief Summary

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

Detailed Description

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

Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Comparator

AD-208 and Placebo of AD-2081

Group Type ACTIVE_COMPARATOR

AD-208

Intervention Type DRUG

PO, Once daily(QD), 24weeks

placebo of AD-2081

Intervention Type DRUG

PO, Once daily(QD), 24weeks

Placebo Comparator

Placebo of AD-208 and Placebo of AD-2081

Group Type PLACEBO_COMPARATOR

placebo of AD-208

Intervention Type DRUG

PO, Once daily(QD), 24weeks

placebo of AD-2081

Intervention Type DRUG

PO, Once daily(QD), 24weeks

Experimental Comparator

Placebo of AD-208 and AD-2081

Group Type EXPERIMENTAL

AD-2081

Intervention Type DRUG

PO, Once daily(QD), 24weeks

placebo of AD-208

Intervention Type DRUG

PO, Once daily(QD), 24weeks

Interventions

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AD-208

PO, Once daily(QD), 24weeks

Intervention Type DRUG

AD-2081

PO, Once daily(QD), 24weeks

Intervention Type DRUG

placebo of AD-208

PO, Once daily(QD), 24weeks

Intervention Type DRUG

placebo of AD-2081

PO, Once daily(QD), 24weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Addpharma Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 40736519 (View on PubMed)

Other Identifiers

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AD-208P3

Identifier Type: -

Identifier Source: org_study_id

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