A Phase 2 interventional study of PDI-192 and Vehicle in Atopic Dermatitis, sponsored by PreCision Dermatology, Inc.. Completed at 9 sites in United States. Open to participants aged 3 Months to 17 Years. Per ClinicalTrials.gov, last updated 2014-05-29.
Sponsored by PreCision Dermatology, Inc. · Phase 2, Interventional, and Treatment
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.
1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.
This study's enrollment of 151 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.
Browse Dermatitis, Atopic studies →PreCision Dermatology, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
topical foam, 0.1% concentration, twice daily
Drug: PDI-192
topical foam, 0.15% concentration, twice daily
Drug: PDI-192
topical foam, 0% concentration, twice daily
Drug: Vehicle
"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.
Time frame: Baseline and Day 29
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.
Time frame: Baseline and Day 29
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).
Time frame: Baseline and Day 29
Change in Body Surface Area (BSA) Affected
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
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).
Time frame: Baseline and Days 8, 15 and 29
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.
Time frame: Baseline and Days 8 and 15
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).
Time frame: Day 29
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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PreCision Dermatology, Inc.