Conditions: Atopic Dermatitis (AD)
Keywords: Eczema Skin Irritation
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: yes

Brief summary:
The purpose of this 14-day, two phase clinical study is to test the tolerance of a new over-the-counter moisturizing balm on subjects with eczema.

Detailed description:
At least 60 subjects will be enrolled to ensure 40 (10 adults and 30 babies) completed subjects. The tolerability of this formulation will be monitored in a small group of ten adult subjects with mild to moderate eczema prior to testing in babies. In Group A, adults will be asked to give their informed consent and an evaluation of inclusion/exclusion criteria will be performed at the site. After screening, all subjects will be asked not to use any skin treatments until the next clinic visit. Subjects will use the investigational product as indicated at least twice per day on the face - cheeks only, arms, legs and torso for 14 days. For both adults and babies, only the baseline measurements are collected at 5-10 minutes after first application, but not at Day 1, Day 7 and Day 14 visits. Babies from 6 to 36 months of age with mild to moderate eczema, who meet the eligibility criteria, will follow a similar testing directions in Group B of the study.

Arms:
arm 1: Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin arm 2: Apply thin layer of experimental product to the affected skin areas at least 2 times per day and massage gently into skin

Interventions: intervention 1: Experimental Product
Intervention descriptions: intervention 1: 1% Colloidal Oatmeal Balm

Protocol document: