Status:
TERMINATED
Safety and Efficacy of Pimecrolimus Cream 1% in Atopic Disease Modification
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
3-18 years
Phase:
PHASE4
Brief Summary
This study consists of a 3-year double-blind phase during which patients will receive atopic dermatitis (AD) treatment either with pimecrolimus cream 1% long-term management (LTM) or with a convention...
Eligibility Criteria
Inclusion
- Diagnosis of atopic dermatitis
- Family history of atopy
- 3 to 18 months of age at baseline
- At least mild atopic dermatitis at baseline (investigator global assessment \[IGA\] greater or equal to 2)
- Clinical evidence of atopic dermatitis for no longer than 3 months
Exclusion
- Diagnosis of or substantial clinical evidence for food or other allergies at baseline
- Other protocol related criteria may apply
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
1091 Patients enrolled
Trial Details
Trial ID
NCT00124709
Start Date
October 1 2003
End Date
November 1 2008
Last Update
March 23 2011
Active Locations (36)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama Allergy and Asthma Center
Birmingham, Alabama, United States, 35209
2
Northwest Arkansas Pediatric Clinic, P.A.
Fayetteville, Arkansas, United States, 72703
3
The Children's Clinic of Jonesboro
Jonesboro, Arkansas, United States, 72401
4
Southern California Research
Mission Viejo, California, United States, 92691