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NCT00208026 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Elidel (Pimecrolimus) 1% Cream to Treat Netherton Syndrome
A Phase 1 study of Netherton Syndrome, sponsored by Children's Hospital of Philadelphia.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
- 1
- Study location
NCT00208026: Completed Phase 1 study of Netherton Syndrome, sponsored by Children's Hospital of Philadelphia.
NCT00208026 is a Phase 1 study of Netherton Syndrome that has completed, run by Children's Hospital of Philadelphia. The registered enrollment target is 3 participants, below the 28-participant average among 6 other Netherton Syndrome trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00208026, a Phase 1 study of Netherton Syndrome, has completed, sponsored by Children's Hospital of Philadelphia.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
At each scheduled visit, blood concentration of pimecrolimus were obtained. This value reflects the amount of pimecrolimus in the blood. This is measured directly from the blood and provides an estimate of the degree of absorption of the treatment medication through the skin into the blood.
Conditions Studied
Interventions
- DRUG Pimecrolimus 1% Cream
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2005-09 |
| Est. Completion | 2008-03 |
| Phase | Phase 1 |
What the finished NCT00208026 record still lists
NCT00208026 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 28-participant average among 6 other Netherton Syndrome trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Netherton Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Pimecrolimus 1% Cream is the first listed.
NCT00208026 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00208026 about?
NCT00208026 is a clinical study titled "Safety Study of Elidel (Pimecrolimus) 1% Cream to Treat Netherton Syndrome". 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 lev...
What is the current status of trial NCT00208026?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2005-09. Estimated completion is 2008-03.
What conditions does trial NCT00208026 study?
This clinical trial studies the following conditions: Netherton Syndrome.
What interventions are being tested in trial NCT00208026?
The interventions under investigation include: Pimecrolimus 1% Cream (DRUG).
Who is sponsoring clinical trial NCT00208026?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00208026 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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