This is a single-center, randomized, blinded, controlled trial assessing the effects on the skin microbiome in patients with eczema of amending a standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation with a modified plant oil ("Activated Oil", AO). The AO contains proprietary blends of plant oils that have selective antimicrobial properties.
Standard-of-care (SOC), over-the-counter (OTC) topical colloidal oatmeal formulation
Center for Clinical Studies
Houston, Texas, United States
RECRUITINGAtopic Dermatitis Severity Index (ADSI) score
Change in mean Atopic Dermatitis Severity Index (ADSI) score from baseline between the protocol and control arms by the 14-day application period. The ADSI comprises an assessment of erythema, pruritus, exudation, excoriation, and lichenification, each on a scale of 0 to 3 to give a maximum score of 15. The maximum score means a worsen condition.
Time frame: 14 days
Change in absolute abundance of S. aureus on target lesion site
Difference in reduction in absolute abundance of S. aureus on target lesion site compared to initial absolute abundance at target lesion site (Baseline measurement) between the protocol and control arms by 14-day application period of application period.
Time frame: 14 days
Change in relative abundance of S. aureus on non-lesion site
Change in relative abundance of S. aureus on non-lesion site compared to initial relative abundance at target lesion site (Baseline measurement) between the protocol and control arms.
Time frame: 14 days
Change in absolute abundance of S. aureus and S. epidermidis on target lesion versus non-lesion site.
Change in absolute abundance of S. aureus and S. epidermidis on the target lesion site compared to the initial absolute abundance of S. aureus and S. epidermidis at the non-lesion site (Baseline measurement) between the protocol and control arms.
Time frame: 14 days
Change in Shannon Diversity Index between the target lesion site and non-lesion site
Change in Shannon Diversity Index between the target lesion site compared to the initial Shannon Diversity Index at the non-lesion site (Baseline measurement).
Time frame: 14 days
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Change in Eczema Area and Severity Index (EASI) score
Change in mean Eczema Area and Severity Index (EASI) score from baseline between the protocol and control arms. An EASI score is a tool used to measure the extent (area) and severity of atopic eczema (Eczema Area and Severity Index). For more information, see Hanifin JM, et al. The eczema area and severity index (EASI): assessment of reliability in atopic dermatitis. EASI Evaluator Group. Exp Dermatol. 2001 Feb;10(1):11-8.
Time frame: 14 days