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

NCT01826461 | Completed Phase 2

• 1 other identifier: 172-0151-202
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 9

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.

Conditions

Atopic Dermatitis

Keywords

atopic dermatitis; eczema; PDI-192; Precision

Outcome Measures

Primary Outcomes (1)

• "Treatment Success" based on change in Investigator's Global Assessment (IGA)

  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.

  Baseline and Day 29

Secondary Outcomes (1)

• Change in Pruritis Severity at Day 29

  Baseline and Day 29

Other Outcomes (5)

• Change in Eczema Area and Severity Index (EASI) Score

  Baseline and Day 29

• Change in Body Surface Area (BSA) Affected

  Baseline, Days 8, 15 and 29

• Change in Clinical Signs of Atopic Dermatitis (AD)

  Baseline and Days 8, 15 and 29

Study Arms (3)

PDI-192 Foam, 0.1%

EXPERIMENTAL

topical foam, 0.1% concentration, twice daily

Drug: PDI-192

PDI-192 Foam, 0.15%

EXPERIMENTAL

topical foam, 0.15% concentration, twice daily

Drug: PDI-192

Vehicle Foam

PLACEBO COMPARATOR

topical foam, 0% concentration, twice daily

Drug: Vehicle

Interventions

PDI-192 DRUG

PDI-192 Foam, 0.1%; PDI-192 Foam, 0.15%

Vehicle DRUG

Vehicle Foam

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PreCision Dermatology, Inc.: lead

Study Sites (9)

UCSD - Rady Children's Hospital

San Diego, California, United States

Location

Northwestern University

Chicago, Illinois, United States

Location

Sneeze, Wheeze & Itch Associates, LLC

Normal, Illinois, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Location

Dermatology Consulting Services

High Point, North Carolina, United States

Location

DermResearch, Inc.

Austin, Texas, United States

Location

UT Houston Health Science Center

Houston, Texas, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Syd Dromgoole, PhD

  Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 8, 2013
• Study Start: March 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 29, 2014

Record last verified: 2014-05

Locations

US (9)