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

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

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.

Study Overview

• Status: Completed
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Vehicle; Drug: PDI-192

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States
      • UCSD - Rady Children's Hospital
  • Illinois
    • Chicago, Illinois, United States
      • Northwestern University
    • Normal, Illinois, United States
      • Sneeze, Wheeze & Itch Associates, LLC
  • Minnesota
    • Fridley, Minnesota, United States
      • Minnesota Clinical Study Center
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Academic Dermatology Associates
  • North Carolina
    • High Point, North Carolina, United States
      • Dermatology Consulting Services
  • Texas
    • Austin, Texas, United States
      • Dermresearch, Inc.
    • Houston, Texas, United States
      • UT Houston Health Science Center
  • Virginia
    • Norfolk, Virginia, United States
      • Virginia Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PDI-192 Foam, 0.1%; topical foam, 0.1% concentration, twice daily	Drug: PDI-192
EXPERIMENTAL: PDI-192 Foam, 0.15%; topical foam, 0.15% concentration, twice daily	Drug: PDI-192
PLACEBO_COMPARATOR: Vehicle Foam; topical foam, 0% concentration, twice daily	Drug: Vehicle

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Eczema Area and Severity Index (EASI) Score	Percent change from Baseline in EASI scores at Day 29. EASI excludes non-key signs of eczema (such as xerosis and scaling, oozing and crusting), and subjective parameters (such as pruritus and sleep loss) in order to focus the index on key disease signs and to avoid mixing objective parameters with subjective symptoms. EASI scores range from 0 (least severe) to 72 (most severe).	Baseline and Day 29
Change in Body Surface Area (BSA) Affected	Percent change from Baseline in the percent BSA affected by disease at Days 8, 15 and 29.	Baseline, Days 8, 15 and 29
Change in Clinical Signs of Atopic Dermatitis (AD)	Change from Baseline in severity of erythema, induration/papulation, excoriation, lichenification and oozing/crusting at Days 8, 15, and 29. All clinical signs are evaluated on a 4-point ordinal scale from 0 (none) to 3 (severe).	Baseline and Days 8, 15 and 29
Change in Pruritis Severity at Days 8 and 15	Change from Baseline in the severity of pruritus (itching) at Days 8 and 15. Pruritis severity is based on a periodic subject assessment using a 4-point ordinal scale from 0 = none to 3 = severe.	Baseline and Days 8 and 15
Subject Assessment of Improvement in Atopic Dermatitis	Subject global assessment of improvement in AD at Day 29, based on a 5-point ordinal scale from 1 (excellent improvement) to 5 (worse).	Day 29

Collaborators and Investigators

• Sponsor: PreCision Dermatology, Inc.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): December 1, 2013

Study Registration Dates

• First Submitted: April 1, 2013
• First Submitted That Met QC Criteria: April 3, 2013
• First Posted (ESTIMATE): April 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): May 29, 2014
• Last Update Submitted That Met QC Criteria: May 27, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: atopic dermatitis; eczema; Precision; PDI-192
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: 172-0151-202