Conditions: Eczema
Keywords: Atopic Dermatitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 23
Healthy volunteers: no

Brief summary:
The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin.

Detailed description:
50 infants and toddlers will be enrolled in this study to yield 40 completed subjects, 30 babies in the active treatment group and 10 babies in the positive control group.

Infants and toddlers aged 6 to 47 months inclusive will receive either a prescription or non-marketed investigational product for the treatment of eczema. Caregivers will be asked to stop use of prescription eczema treatments one week before the start of the study and during the study. Caregivers will apply study product to babies as indicated for 14 days to affected areas.

Subject caregivers will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the babies eczema and symptoms. Skin moisture levels will also be tested.

Arms:
arm 1: Marketed. Apply in a thin layer to the affected skin areas two times per day (or as needed) and massage gently into the skin. arm 2: Not Yet Marketed. Apply in a thin layer to the affected skin areas at least once at night or more if needed (anytime), and massage gently into the skin.

Interventions: intervention 1: EpiCeram Skin Barrier Emulsion intervention 2: 1% Colloidal Oatmeal Balm
Intervention descriptions: intervention 1: EpiCeram Skin Barrier Emulsion intervention 2: Experimental Product 1% Colloidal Oatmeal Balm

Protocol document: