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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826461
• Other study ID #: 172-0151-202
• Status: Completed
• Phase: Phase 2
• First received: April 1, 2013
• Last updated: May 27, 2014
• Start date: March 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: PreCision Dermatology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 17 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• PDI-192

• Vehicle

Locations

Country	Name	City	State
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch, Inc.	Austin	Texas
United States	Northwestern University	Chicago	Illinois
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Dermatology Consulting Services	High Point	North Carolina
United States	UT Houston Health Science Center	Houston	Texas
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Sneeze, Wheeze & Itch Associates, LLC	Normal	Illinois
United States	UCSD - Rady Children's Hospital	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
PreCision Dermatology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Eczema Area and Severity Index (EASI) Score	Percent change from Baseline in EASI scores at Day 29. EASI excludes non-key signs of eczema (such as xerosis and scaling, oozing and crusting), and subjective parameters (such as pruritus and sleep loss) in order to focus the index on key disease signs and to avoid mixing objective parameters with subjective symptoms. EASI scores range from 0 (least severe) to 72 (most severe).	Baseline and Day 29	No
Other	Change in Body Surface Area (BSA) Affected	Percent change from Baseline in the percent BSA affected by disease at Days 8, 15 and 29.	Baseline, Days 8, 15 and 29	No
Other	Change in Clinical Signs of Atopic Dermatitis (AD)	Change from Baseline in severity of erythema, induration/papulation, excoriation, lichenification and oozing/crusting at Days 8, 15, and 29. All clinical signs are evaluated on a 4-point ordinal scale from 0 (none) to 3 (severe).	Baseline and Days 8, 15 and 29	No
Other	Change in Pruritis Severity at Days 8 and 15	Change from Baseline in the severity of pruritus (itching) at Days 8 and 15. Pruritis severity is based on a periodic subject assessment using a 4-point ordinal scale from 0 = none to 3 = severe.	Baseline and Days 8 and 15	No
Other	Subject Assessment of Improvement in Atopic Dermatitis	Subject global assessment of improvement in AD at Day 29, based on a 5-point ordinal scale from 1 (excellent improvement) to 5 (worse).	Day 29	No
Primary	"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	No
Secondary	Change in Pruritis Severity at Day 29	Change from Baseline in the severity of pruritus (itching) at Day 29. Pruritis severity is based on a periodic subject assessment using a 4-point ordinal scale from 0 = none to 3 = severe.	Baseline and Day 29	No