Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema
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.
Timeline
- Start
- 2016-02
- Primary completion
- 2016-04
- Completion
- 2016-04
Outcome
Missed primary endpoint
registry 1% Colloidal Oatmeal Balm vs EpiCeram Skin Barrier Emulsion; p = 0.616; Mean Difference (Final Values) 0.40 (95% CI -1.196 to 1.998); ANCOVA; NCT02691507 ↗
registry 1% Colloidal Oatmeal Balm vs EpiCeram Skin Barrier Emulsion; p = 0.297; Mean Difference (Final Values) 0.85 (95% CI -0.767 to 2.460); ANCOVA; NCT02691507 ↗
registry 1% Colloidal Oatmeal Balm vs EpiCeram Skin Barrier Emulsion; p = 0.394; Mean Difference (Final Values) 0.73 (95% CI -0.973 to 2.426); ANCOVA; NCT02691507 ↗
registry 1% Colloidal Oatmeal Balm vs EpiCeram Skin Barrier Emulsion; p = 0.690; Mean Difference (Final Values) 0.28 (95% CI -1.140 to 1.709); ANCOVA; NCT02691507 ↗
registry 1% Colloidal Oatmeal Balm vs EpiCeram Skin Barrier Emulsion; p = 0.914; Mean Difference (Final Values) -0.08 (95% CI -1.556 to 1.397); ANCOVA; NCT02691507 ↗
registry 1% Colloidal Oatmeal Balm vs EpiCeram Skin Barrier Emulsion; p = 0.757; Mean Difference (Final Values) -0.24 (95% CI -1.796 to 1.314); ANCOVA; NCT02691507 ↗
registry 1% Colloidal Oatmeal Balm vs EpiCeram Skin Barrier Emulsion; p = 0.556; Mean Difference (Final Values) -0.47 (95% CI -2.075 to 1.129); ANCOVA; NCT02691507 ↗
registry 1% Colloidal Oatmeal Balm vs EpiCeram Skin Barrier Emulsion; p = 0.106; Mean Difference (Final Values) -1.27 (95% CI -2.824 to 0.278); ANCOVA; NCT02691507 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colloidal Oatmeal Balm | Other / unclassified | 1 % | Topical |