A Phase 2 Study to Evaluate the Safety and Efficacy of CKD-498 in Female Patients With Androgenetic Alopecia

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

PHASE2

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-20

Study Completion Date

2023-12-15

Brief Summary

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This is a multi-centers, randomized, double-blind, parallel-group, Phase 2 Trial to evaluate the efficacy and safety of CKD-498 in female patients with Androgenetic Alopecia

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Detailed Description

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Participants were randomly assigned in a 1:1:1:1 ratio to the following group: 3 dose of CKD-498 and Placebo. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 24 weeks.

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

TRIPLE

Participants Caregivers Investigators

oral, once daily, 24 weeks

Intervention Type DRUG

Placebo of CKD-498 dose#1

oral, once daily, 24 weeks

Intervention Type DRUG

Placebo of CKD-498 dose#2

oral, once daily, 24 weeks

Intervention Type DRUG

Placebo of CKD-498 dose#3

oral, once daily, 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female of age 19-54 years
* Clinical Diagnosis of Androgenetic Alopecia
* Written informed consent

Exclusion Criteria

* Other types of Alopecia or other diseases that can cause hair loss
* Clinically significant scalp disease such as seborrheic dermatitis or psoriasis
* Clinically significant hepatic disease, thyroid disease, or mental illness, as determined by the Investigator
* Women who are pregnant or breastfeeding
* Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of study drug

Minimum Eligible Age

19 Years

Maximum Eligible Age

54 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No