A Test to Determine the Usefulness and Safety of a Cream Used on Babies With Dry Itchy Skin
Summary
This study is for infants with mild to moderate dry and itchy skin. This study will involve going to the doctor for 6 visits over 2 weeks. All participants' skin will be examined by a dermatologist to determine if they have atopic dermatitis and have an active mild to moderate eczema wound. Participant's parents/guardians will be asked a few questions to determine if their child qualifies for the study. Then all participants' caregivers will complete a questionnaire at the beginning of the study. The child's skin will be examined to rate the level of their eczema and a trained examiner will grade the looks and symptoms of their eczema. All parents or guardians will be instructed how to apply the test product and how to record usage on a diary card and then apply the test product. The test product will be applied at least 2 times per day or more as needed on all body areas, including the face affected throughout the study. One digital picture will be taken of one eczema wound. Another digital picture will be taken of the area around this wound. These pictures will be taken on Day 0 (Baseline), Day 3, and Day 14. Once product is applied the skin will be examined for any adverse events and all participants' caregivers will complete a questionnaire on study day 1, 3, 7 and 14.
Timeline
- Start
- 2014-03
- Primary completion
- 2014-11
- Completion
- 2014-11
Outcome
Missed primary endpoint
registry analysis (superiority or other test); 1% Colloidal Oatmeal Eczema Cream vs EpiCeram® Skin Barrier Emulsion; p = 0.0510 NCT02120833 ↗
registry analysis (superiority or other test); 1% Colloidal Oatmeal Eczema Cream vs EpiCeram® Skin Barrier Emulsion; p = 0.7698 NCT02120833 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colloidal Oatmeal Cream | Unknown | — | Topical |