CAPTAIN-AD: Clinical Study of AmorePacific's TRPV1 Antagonist in Atopic Dermatitis

Study Overview
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Brief Summary
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This is a phase III study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

Detailed Description
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PAC-14028 cream 1.0% or placebo will be treated to Mild to Moderate Atopic Dermatitis patients twice daily for 8 weeks.

Official Title
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Multi Center, Randomized, Double-blind, Placebo-controlled Parallel-group, Phase III Clinical Trial to Evaluate the Safety and Efficacy of PAC-14028 Cream in Mild to Moderate Atopic Dermatitis Patients

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: PAC-14028 cream 1.0%
* Drug: PAC-14028 cream Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged 12 - 70 years. Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria. Whose affected TBSA is over 5% and below 30%, and IGA score is 2 (mild) to 3 (moderate). Who voluntarily agreed to participate in the study and signed an informed consent form. Exclusion Criteria: Who has skin diseases other than atopic dermatitis or scar in the affected area which can affect the study, determined by the study investigators. Who has clinically significant medical history or diseases involving liver, kidney, neurological system, psychical disorder that can affect study results. Who has used systemic steroids, antibiotics, immunosuppressants, or received phototherapy within 28 days before study drug administration. Who has used topical steroids, topical calcineurin inhibitors or antibiotics to treat atopic dermatitis within 14 days before study drug administration. Who has used or is expected to inevitably use prohibited concomitant medications during the study. Women who is pregnant /breast-feeding, or who has childbearing potential and does not use available contraceptives. Who has dosed other study medications within 30 days before screening. Who is determined ineligible for study participation by investigators for any other reasons.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PAC-14028 cream 1.0%<br>PAC-14028 cream 1.0% will be applied to treatment area twice daily for 8 weeks. | Drug: PAC-14028 cream 1.0%<br>* topical application<br>|
| Placebo Comparator: PAC-14028 cream Vehicle<br>PAC-14028 cream Vehicle will be applied to treatment area twice daily for 8 weeks. | Drug: PAC-14028 cream Vehicle<br>* topical application<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of Investigator's Global Assessment (IGA) | Percent of patients with IGA score of 0 (clear) or 1 (almost clear) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Investigator's Global Assessment (IGA) score | Change of IGA score from baseline | 8 weeks | 
| Success rate of ≥2-grade Investigator's Global Assessment (IGA) | percent of patients with ≥2 grade reduction of IGA score | 8 weeks | 
| Percent of change in Eczema Area and Severity Index (EASI) |  | 8 weeks |