Title
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
Phase
Phase 2Lead Sponsor
PreCision DermatologyStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Atopic DermatitisIntervention/Treatment
pdi-192 ...Study Participants
151This 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.
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.
