An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
PDI-192
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring atopic dermatitis, eczema, PDI-192, Precision
Eligibility Criteria
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.
Sites / Locations
- UCSD - Rady Children's Hospital
- Northwestern University
- Sneeze, Wheeze & Itch Associates, LLC
- Minnesota Clinical Study Center
- Academic Dermatology Associates
- Dermatology Consulting Services
- DermResearch, Inc.
- UT Houston Health Science Center
- Virginia Clinical Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
PDI-192 Foam, 0.1%
PDI-192 Foam, 0.15%
Vehicle Foam
Arm Description
topical foam, 0.1% concentration, twice daily
topical foam, 0.15% concentration, twice daily
topical foam, 0% concentration, twice daily
Outcomes
Primary Outcome Measures
"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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01826461
First Posted
April 1, 2013
Last Updated
May 27, 2014
Sponsor
PreCision Dermatology, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01826461
Brief Title
An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PreCision Dermatology, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
atopic dermatitis, eczema, PDI-192, Precision
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
151 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PDI-192 Foam, 0.1%
Arm Type
Experimental
Arm Description
topical foam, 0.1% concentration, twice daily
Arm Title
PDI-192 Foam, 0.15%
Arm Type
Experimental
Arm Description
topical foam, 0.15% concentration, twice daily
Arm Title
Vehicle Foam
Arm Type
Placebo Comparator
Arm Description
topical foam, 0% concentration, twice daily
Intervention Type
Drug
Intervention Name(s)
PDI-192
Intervention Type
Drug
Intervention Name(s)
Vehicle
Primary Outcome Measure Information:
Title
"Treatment Success" based on change in Investigator's Global Assessment (IGA)
Description
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.
Time Frame
Baseline and Day 29
Secondary Outcome Measure Information:
Title
Change in Pruritis Severity at Day 29
Description
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.
Time Frame
Baseline and Day 29
Other Pre-specified Outcome Measures:
Title
Change in Eczema Area and Severity Index (EASI) Score
Description
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).
Time Frame
Baseline and Day 29
Title
Change in Body Surface Area (BSA) Affected
Description
Percent change from Baseline in the percent BSA affected by disease at Days 8, 15 and 29.
Time Frame
Baseline, Days 8, 15 and 29
Title
Change in Clinical Signs of Atopic Dermatitis (AD)
Description
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).
Time Frame
Baseline and Days 8, 15 and 29
Title
Change in Pruritis Severity at Days 8 and 15
Description
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.
Time Frame
Baseline and Days 8 and 15
Title
Subject Assessment of Improvement in Atopic Dermatitis
Description
Subject global assessment of improvement in AD at Day 29, based on a 5-point ordinal scale from 1 (excellent improvement) to 5 (worse).
Time Frame
Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syd Dromgoole, PhD
Organizational Affiliation
Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
UCSD - Rady Children's Hospital
City
San Diego
State/Province
California
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Sneeze, Wheeze & Itch Associates, LLC
City
Normal
State/Province
Illinois
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
Country
United States
Facility Name
Academic Dermatology Associates
City
Albuquerque
State/Province
New Mexico
Country
United States
Facility Name
Dermatology Consulting Services
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
Country
United States
Facility Name
UT Houston Health Science Center
City
Houston
State/Province
Texas
Country
United States
Facility Name
Virginia Clinical Research, Inc.
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis
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