Efficacy and Safety of Pimecrolimus Cream 1% in Patients ≥ 3 Months of Age With Mild or Moderate Atopic Dermatitis
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...
Brief Summary
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Healthcare Philippines Study Chair Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00150059
