At a glance
ClinicalIndex Comparison Record- ✓Clinical diagnosis of Netherton syndrome
- ✓Normal laboratory values within 3 months prior to enrollment
- ✓Willingness and ability to comply with the study requirements
- ✕Clinically significant physical examination or laboratory abnormalities
- ✕Clinical evidence of liver disease or liver injury as documented by abnormal liver function tests
- ✕Symptoms of a significant acute illness in the 30 week period preceding the start of treatment
- ✕Known serious adverse reactions or hypersensitivity to macrolides or calcineurin inhibitors or any ingredients of the study medication
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Exploratory Safety and Systemic Absorption of Elidel (Pimecrolimus) 1% Cream for the Treatment of Netherton Syndrome
In Brief
A Phase 2 clinical trial evaluating Pimecrolimus 1% Cream for Netherton Syndrome. Completed, enrolled 3 participants across 1 site.
Detailed Summary
Netherton syndrome is a genetic condition that can result in abnormal skin functioning. People with this condition often have red and scaling skin; sparse or short hair; and problems with absorption of medicines or chemicals that are applied to the skin. If these chemicals are absorbed at a high level, they may cause health problems. Elidel (pimecrolimus) is a new medicine that is available as a cream. It has been shown to help improve the appearance of the skin in patients with another skin condition known as atopic dermatitis, and is approved by the United States (US) Food and Drug Administration for use in children with mild to moderate atopic dermatitis. The purpose of this study is to determine if Elidel is safe, to see whether the medication is absorbed through the skin, and to see if side effects are associated with its use in children with Netherton syndrome.
Study Details
Timeline
Interventions
Open label single arm