To evaluate the efficacy and safety of pimecrolimus cream 1% in its registered indication (treatment of patients > 3 months of age with mild to moderate atopic dermatitis) This study is not enrolling patients in the United States...
Date First Received: September 7, 2005
Last Updated: February 14, 2008
Verified by: Novartis, February 2008
Clinical Trial Phase: Phase 4 | Start Date: December 2004
Overall Status: Completed
Brief Summary
Condition Keyword(s):
Intervention(s):
To evaluate the efficacy and safety of pimecrolimus cream 1% in its registered indication (treatment of patients > 3 months of age with mild to moderate atopic dermatitis)
This study is not enrolling patients in the United States.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Pimecrolimus Cream 1%
Outcome Measures for this Clinical Trial
Primary Measures
- Investigator Global Assessment (IGA) score for the whole body and for the face only.
- Pruritus (itch) severity assessments, and patient's self-assessment of disease control at the start of study and on day 7, 30 and 90 after treatment initiation.
- Safety assessed by adverse events.
Criteria for Participation in this Clinical Trial
- The patient population must consist of male or female outpatients, age ≥3 months old with mild to moderate atopic dermatitis (IGA ≥ 1). Exclusion criteria are pregnancy, having active viral infections at the site(s) of treatment, presenting with systemic malignancy or active lymphoproliferative diseases/disorders, receiving phototherapy or immunosuppressive therapy, having used tacrolimus ointment and known allergy or hypersensitivity.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 3 Months
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Healthcare Philippines Study Chair Novartis
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00150059
Study ID Number: CASM981CPH01
ClinicalTrials.gov Identifier: NCT00150059
Health Authority: Philippines: Bureau of Food and Drugs
Clinical Trials Authorship and Review
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