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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PDI-192 Foam, 0.1%

topical foam, 0.1% concentration, twice daily

Group Type EXPERIMENTAL

PDI-192

Intervention Type DRUG

PDI-192 Foam, 0.15%

topical foam, 0.15% concentration, twice daily

Group Type EXPERIMENTAL

PDI-192

Intervention Type DRUG

Vehicle Foam

topical foam, 0% concentration, twice daily

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Interventions

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PDI-192

Intervention Type DRUG

Vehicle

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

3 Months

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No