Registry of children with eczema using Pimecrolimus
A Prospective 10 Year Observational Registry of Pediatric Subjects (Age Greater Than or Equal to Two Years to Age Less Than or Equal to 17 Years) With Atopic Dermatitis Who Have Used Elidel Cream 1% (Pimecrolimus)
This study is tracking children aged 2 to 17 who use Elidel cream for eczema to see if it affects their health over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 8000 (estimated) |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Sponsor | Bausch Health Americas, Inc. Industry-sponsored |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT00568997 on ClinicalTrials.gov |
What this trial studies
This registry study aims to evaluate the risk of systemic malignancies in pediatric patients aged 2 to 17 years who have been treated with Elidel 1% cream for atopic dermatitis. The study will track these patients over a 10-year period to gather data on their health outcomes. By monitoring the long-term effects of this treatment, researchers hope to provide valuable insights into its safety profile. The study involves collecting data from participants who meet specific eligibility criteria regarding their age and treatment history.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 to 17 years diagnosed with atopic dermatitis who have used Pimecrolimus cream.
Not a fit: Patients with a history of systemic malignancies or those who have used oral immunosuppressive therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the safety of Pimecrolimus in children with eczema, potentially leading to safer treatment options.
How similar studies have performed: While this study focuses on a specific population and treatment, similar observational studies have provided valuable safety data for other dermatological treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * males and females * greater than or equal to 2 years and less than or equal to 17 years at enrollment * diagnosis of atopic dermatitis (confirmed by treating physician) * applied pimecrolimus cream 1 % 6 weeks out of past 24 weeks Exclusion Criteria: * past or present history of systemic malignancy, skin malignancy, or lymphoproliferative disease * past or present use of oral immunosuppressive therapy
Where this trial is running
Philadelphia, Pennsylvania
- Registry — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Sandra Narain
- Email: sandra.narain@bauschhealth.com
- Phone: 908-242-8287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.