Atopic Dermatitis
Conditions
Keywords
atopic dermatitis, eczema, PDI-192, Precision
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.
Interventions
DRUGPDI-192
DRUGVehicle
Sponsors
PreCision Dermatology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Months to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success based on change in Investigator's Global Assessment (IGA) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Pruritis Severity at Day 29 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Signs of Atopic Dermatitis (AD) | 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 Eczema Area and Severity Index (EASI) Score | 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). |
| Subject Assessment of Improvement in Atopic Dermatitis | 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). |
| Change in Pruritis Severity at Days 8 and 15 | 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. |
| Change in Body Surface Area (BSA) Affected | Baseline, Days 8, 15 and 29 | Percent change from Baseline in the percent BSA affected by disease at Days 8, 15 and 29. |
Countries
United States
Outcome results
None listed