A Study to Evaluate the Safety and Efficacy of PAC-14028 Cream in Adults With Atopic Dermatitis

Study Overview
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Brief Summary
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This is a phase 2 study to investigate the safety and efficacy of PAC-14028 cream in Atopic Dermatitis patients.

Detailed Description
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PAC-14028 Cream (0.1%, 0.3%, 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 II 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 0.1%
* Drug: PAC-14028 cream 0.3%
* 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 19 - 70 years. Who was diagnosed with Atopic Dermatitis according to Haniffin and Rajka criteria. Whose affected BSA is over 5% 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 photochemical therapy within 28 days before study drug administration. Who has used topical steroids, immunosuppressants 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: 19 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 0.1%<br>PAC-14028 cream 0.1%, Twice daily for 8 weeks | Drug: PAC-14028 cream 0.1%<br>* Topical application<br>|
| Experimental: PAC-14028 cream 0.3%<br>PAC-14028 cream 0.3%, Twice daily for 8 weeks | Drug: PAC-14028 cream 0.3%<br>* Topical application<br>|
| Experimental: PAC-14028 cream 1.0%<br>PAC-14028 cream 1.0%, 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, 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 |
| --- | --- | --- |
| Success rate of Investigator's Global Assessment (IGA) | percent of patients with IGA score of 0 (clear) or 1 (almost clear) | 1, 3, 6 week(s) | 
| Change in SCORAD (Severity Score of Atopic Dermatitis) |  | 1, 3, 6, 8 week(s) | 
| % Change in Eczema Area and Severity Index (EASI) |  | 1, 3, 6, 8 week(s) | 
| Success rate of Pruritus Severity score |  | 1, 3, 6, 8 week(s) |