drugset / Trial / NCT00616538

Epiceram™ Device Versus Mid-Strength Topical Steroid (Fluticasone Propionate 0.05%) for Treatment of Atopic Dermatitis

NCT00616538

Phase 4 Completed 121 enrolled Ceragenix Pharmaceuticals
RandomizedParallel-groupSingle-blindTreatment

Summary

Novel therapies for AD that avoid immunosuppression and potential carcinogensis are needed. EpiCeram™ , a topical cream, represents a novel class of therapy for skin disorders that does not contain corticosteroids or other anti-inflammatory drugs. The objective of the present study is to demonstrate the safety and efficacy of EpiCeram ™ in the treatment of moderate to severe atopic dermatitis as compared to mid-strength topical steroid cream following twice daily dosing for four weeks in pediatric patients with AD. The potential benefit to patients lies in the potential for EpiCeram ™ to provide restoration of the normal skin barrier as shown in previous studies and eliminate or reduce the requirement for supplemental topical steroid administration.

Timeline

Start
2006-12
Primary completion
2007-04
Completion

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone propionate Other / unclassified 0.05 % Topical

Indications