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

Chong Kun Dang

Status and phase: Completed; Phase 2

Conditions: Androgenetic Alopecia

Treatments: Drug: Placebo of CKD-498 dose#2; Drug: CKD-498 dose#2; Drug: Placebo of CKD-498 dose#3; Drug: Placebo of CKD-498 dose#1; Drug: CKD-498 dose#3; Drug: CKD-498 dose#1

Study type: Interventional

Funder types: Industry

Identifiers

NCT05677438

A128_01AGA2211

Details and patient eligibility

About

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

Full description

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.

Enrollment: 121 patients

Sex: Female

Ages: 19 to 54 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

Key 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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121 participants in 4 patient groups, including a placebo group

Test Group1

Experimental group

Treatment:

Drug: CKD-498 dose#1

Drug: Placebo of CKD-498 dose#3

Drug: Placebo of CKD-498 dose#2

Test Group2

Experimental group

Treatment:

Drug: Placebo of CKD-498 dose#1

Drug: Placebo of CKD-498 dose#3

Drug: CKD-498 dose#2

Test Group3

Experimental group

Treatment:

Drug: CKD-498 dose#3

Drug: Placebo of CKD-498 dose#1

Drug: Placebo of CKD-498 dose#2

Placebo Group

Placebo Comparator group

Treatment:

Drug: Placebo of CKD-498 dose#1

Drug: Placebo of CKD-498 dose#3

Drug: Placebo of CKD-498 dose#2