NCT Number: NCT01826461
An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis
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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Notify MeKey information
Conditions
Age range
3 month–17 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
UCSD - Rady Children's Hospital, San Diego, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Vehicle
DrugPrimary outcomes
-
"Treatment Success" based on change in Investigator's Global Assessment (IGA)
Time frame: Baseline and Day 29
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 outcomes
-
Change in Pruritis Severity at Day 29
Time frame: Baseline and 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.
Other outcomes
-
Change in Eczema Area and Severity Index (EASI) Score
Time frame: Baseline and Day 29
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).
-
Change in Body Surface Area (BSA) Affected
Time frame: Baseline, Days 8, 15 and 29
Percent change from Baseline in the percent BSA affected by disease at Days 8, 15 and 29.
-
Change in Clinical Signs of Atopic Dermatitis (AD)
Time frame: Baseline and Days 8, 15 and 29
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).
-
Change in Pruritis Severity at Days 8 and 15
Time frame: Baseline and 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.
-
Subject Assessment of Improvement in Atopic Dermatitis
Time frame: Day 29
Subject global assessment of improvement in AD at Day 29, based on a 5-point ordinal scale from 1 (excellent improvement) to 5 (worse).
Sponsors and collaborators
Lead sponsor
PreCision Dermatology, Inc.
Industry
Registry information
Official study 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
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Apr 8, 2013
- Registry last updated
- May 29, 2014
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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