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

PreCision Dermatology

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: PDI-192; Drug: Vehicle

Study type: Interventional

Funder types: Industry

Identifiers

NCT01826461

172-0151-202

Details and patient eligibility

About

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.

Enrollment: 151 patients

Sex: All

Ages: 3 months to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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151 participants in 3 patient groups, including a placebo group

PDI-192 Foam, 0.1%

Experimental group

Description:

topical foam, 0.1% concentration, twice daily

Treatment:

Drug: PDI-192

PDI-192 Foam, 0.15%

Experimental group

Description:

topical foam, 0.15% concentration, twice daily

Treatment:

Drug: PDI-192

Vehicle Foam

Placebo Comparator group

Description:

topical foam, 0% concentration, twice daily

Treatment:

Drug: Vehicle