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

Study Overview
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Brief Summary
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This is a phase 1 and 2 study to assess the safety and efficacy of PAC-14028 cream in children with atopic dermatitis.

Official Title
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A Randomized, Double-blind, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Systemic Exposure and Efficacy of PAC-14028 in Children With Mild to Moderate Pediatric Atopic Dermatitis

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 24 months - 12 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 has applied stable amount of emollients daily before baseline visit 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, psychial 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: 24 Months
Maximum Age: 12 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 4 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 4 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 4 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 4 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) | % of patients with IGA score of 0 (clear) or 1 (almost clear) | 4 weeks | 
| Blood concentrations of PAC-14028 | Blood concentrations of PAC-14028 | Day 1, Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of IGA (Investigator's Global Assessment) | Change of IGA score from baseline | 1, 2, 4 week(s) | 
| Change of SCORAD (Severity Scoring of Atopic Dermatitis) | Change of SCORAD from baseline | 1, 2, 4 week(s) | 
| % Change of EASI (Eczema Area and Severity Index) |  | 1, 2, 4 week(s) | 
| Patient satisfaction measurement |  | 4 weeks |