Status:
COMPLETED
An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis
Lead Sponsor:
PreCision Dermatology, Inc.
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
3-17 years
Phase:
PHASE2
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 de...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT01826461
Start Date
March 1 2013
End Date
December 1 2013
Last Update
May 29 2014
Active Locations (9)
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1
UCSD - Rady Children's Hospital
San Diego, California, United States
2
Northwestern University
Chicago, Illinois, United States
3
Sneeze, Wheeze & Itch Associates, LLC
Normal, Illinois, United States
4
Minnesota Clinical Study Center
Fridley, Minnesota, United States