An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis

Study Overview
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Brief Summary
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This study will compare the safety and efficacy of three test article foams (PDI-192 0.1% Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be selected for future development.

Official Title
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A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Evaluation of Twice Daily PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis in Subjects 3 Months to Less Than 18 Years of Age

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: PDI-192
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject presents with a clinical diagnosis of stable mild to moderate atopic dermatitis. Subject has used the same type of soap, moisturizers, lotions, creams, ointments, sunscreens or other skin products, and hair products (shampoo, etc.) for at least two weeks prior to study start and agrees to continue usage with the same products and with similar frequency for the entire study. Exclusion Criteria: Subject is pregnant, lactating or is planning to become pregnant during the study. Subject requires any topical or systemic medications or is using topical inflammatory dermatoses therapies that could affect the course of their atopic dermatitis during the study period. Subject has used systemic corticosteroids, immunomodulators including leukotriene inhibitors, or antimetabolites within 30 days prior to study start. Subject has used Ultraviolet Light Therapy (PUVA, UVB, etc.) within 30 days prior to study start. Subject has used topical therapies for the treatment of (or may affect) their atopic dermatitis including but not limited to corticosteroids, immunomodulators (tacrolimus, pimecrolimus, etc.), tar, calcipotriene or other vitamin D preparations, retinoids, antihistamines (doxepin, diphenhydramine, etc.), antibiotics, among others, within 14 days prior to study start. Subject desires excessive or prolonged exposure to ultraviolet light (e.g., sunlight, tanning beds) during the study. Subject has used systemic (oral, IV, etc.) antibiotic therapy within seven days prior to study start. Subject is currently enrolled in an investigational drug or device study. Subject has used an investigational drug or investigational device treatment within 30 days prior to study start.

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 17 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PDI-192 Foam, 0.1%<br>topical foam, 0.1% concentration, twice daily | Drug: PDI-192<br> <br> |
| Experimental: PDI-192 Foam, 0.15%<br>topical foam, 0.15% concentration, twice daily | Drug: PDI-192<br> <br> |
| Placebo Comparator: Vehicle Foam<br>topical foam, 0% concentration, twice daily | Drug: Vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Success based on change in Investigator's Global Assessment (IGA) | Success rate, based on IGA score. Success rate is defined as the percentage of subjects who achieve Clear (score = 0) or Almost Clear (score = 1) and at least a 2-grade improvement from Baseline on the IGA score at Day 29. IGA is a measure of overall severity of atopic dermatitis using a 5-point ordinal scale from 0 = clear to 4 = severe. | Baseline and Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pruritis Severity at Day 29 | Change from Baseline in the severity of pruritus (itching) at Day 29. Pruritis severity is based on a periodic subject assessment using a 4-point ordinal scale from 0 = none to 3 = severe. | Baseline and Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atopic dermatitis, eczema, PDI-192, Precision