Clinical trial NCT01826461: An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: atopic dermatitis
eczema
PDI-192
Precision
Lead sponsor: PreCision Dermatology, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-08
Enrollment: 151
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: "Treatment Success" based on change in Investigator's Global Assessment (IGA)
timeFrame: Baseline and Day 29
Secondary outcomes:
measure: Change in Pruritis Severity at Day 29
timeFrame: Baseline and Day 29
Other outcomes:
measure: Change in Eczema Area and Severity Index (EASI) Score
timeFrame: Baseline and Day 29
measure: Change in Body Surface Area (BSA) Affected
timeFrame: Baseline, Days 8, 15 and 29
measure: Change in Clinical Signs of Atopic Dermatitis (AD)
timeFrame: Baseline and Days 8, 15 and 29
measure: Change in Pruritis Severity at Days 8 and 15
timeFrame: Baseline and Days 8 and 15
measure: Subject Assessment of Improvement in Atopic Dermatitis
timeFrame: Day 29
Locations:
city: San Diego
country: United States
facility: UCSD - Rady Children's Hospital
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Normal
country: United States
facility: Sneeze, Wheeze & Itch Associates, LLC
state: Illinois
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: High Point
country: United States
facility: Dermatology Consulting Services
state: North Carolina
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: Houston
country: United States
facility: UT Houston Health Science Center
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Therapeutics, Inc.
name: Syd Dromgoole, PhD
role: STUDY_DIRECTOR
References: