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ID:
4392
Title:
A Clinical Trial to Evaluate the Efficacy of a OTC Colloidal Oatmeal Skin Protectant Cream in the Management of Mild to Moderate Atopic Dermatitis in Infants and Toddlers
Abstract:
Atopic Dermatitis (AD) affects 10-20% of all infants and young children. The associated symptoms, erythema, pruritus, and inflammation, can lead to a significant reduction in overall quality of life (QOL) including sleep disturbances. Thus, management of AD using safe and effective nonprescription topical therapy can be an important strategy for this sensitive population.

The purpose of this study was to evaluate the efficacy of a new over-the-counter (OTC) colloidal oatmeal skin protectant cream in children with mild to moderate AD and sleep disturbances.

This was a single-center, two-arm, evaluator blinded clinical study in subjects aged 6 to 47 months (n=23) with mild to moderate AD as determined by the study physician (graded between 3.0 and 7.5 inclusive per Rajka-Langeland Severity Index). All subjects visited the clinical site for assessments at screening (-14 to -7 days), baseline (Day 0), twice on Day 1, and on Days 3, 7, and 14. Subjects were asked to refrain from using prescription eczema treatment during the seven day run-in period between the screening and baseline visits, and from all eczema treatments on the last two days (washout) prior to the baseline visit, as well as for the duration of the study (acute rescue treatment was permitted). The investigational OTC colloidal oatmeal skin protectant cream and the control, a controlled release skin barrier emulsion, were applied topically per the label instructions, on all affected areas. Clinical and instrumental assessments of moisturization, eczema symptom improvement, caregiver perception of itch, dryness, sleep parameters, and QOL in caregivers were performed.

For the primary endpoints, the OTC cream showed statistically significant increases in moisturization immediately post treatment and 12 hours post treatment (p < 0.001). The OTC cream also showed significant improvement in overall disease severity and extent of disease, skin dryness, caregiver perception of itch, and parameters of sleep quality including duration of continuous sleep and number of wakings at night. Caregiver questionnaires noted significant improvements in overall and eczema skin appearance as well as caregiver QOL.

This study demonstrated that the OTC colloidal oat skin protectant cream was effective and well tolerated in children with mild to moderate AD. The OTC cream provides patients, caregivers, and dermatologists with an alternative therapy to improve eczema symptoms and overall quality of life.
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