Conditions: Atopic Dermatitis
Keywords: Eczema, Itchy Skin
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 53
Healthy volunteers: yes

Brief summary:
The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.

Detailed description:
Approximately 60 subjects will be enrolled to ensure 52 subjects complete the study (39 subjects: active treatment and 13 subjects: positive control).

Adults and children (ages 12 and over) will receive either a marketed or not yet marketed investigational product for the treatment of eczema. Subjects will be asked to stop use of prescription and all eczema treatments 2 days before the start of the study and during the study. Subjects will apply study product as indicated for 7 days to affected areas.

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

Arms:
arm 1: Marketed - EpiCeram(R) Skin Barrier Emulsion: Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin. arm 2: Not Yet Marketed - 1% Colloidal Oatmeal Balm: Apply at least once per night or more if needed.

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

Protocol document: