An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis
- Registration Number
- NCT01826461
- Lead Sponsor
- PreCision Dermatology, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 151
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PDI-192 Foam, 0.1% PDI-192 topical foam, 0.1% concentration, twice daily PDI-192 Foam, 0.15% PDI-192 topical foam, 0.15% concentration, twice daily Vehicle Foam Vehicle topical foam, 0% concentration, twice daily
- Primary Outcome Measures
Name Time Method "Treatment Success" based on change in Investigator's Global Assessment (IGA) Baseline and Day 29 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.
- Secondary Outcome Measures
Name Time Method Change in Pruritis Severity at Day 29 Baseline and 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.
Trial Locations
- Locations (9)
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
UT Houston Health Science Center
🇺🇸Houston, Texas, United States
UCSD - Rady Children's Hospital
🇺🇸San Diego, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Dermatology Consulting Services
🇺🇸High Point, North Carolina, United States
DermResearch, Inc.
🇺🇸Austin, Texas, United States
Sneeze, Wheeze & Itch Associates, LLC
🇺🇸Normal, Illinois, United States