An evaluation of the safety and efficacy of the calcineurin inhibitor, pimecrolimus cream 1%, in adult patients with perioral dermatitis. This study is not enrolling patients in the United States...
Date First Received: October 3, 2005
Last Updated: January 15, 2008
Verified by: Novartis, January 2008
Clinical Trial Phase: Phase 3 | Start Date: September 2005
Overall Status: Completed
Estimated Enrollment: 124
Brief Summary
Official Title: “Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis”
Condition Keyword(s):
Intervention(s):
An evaluation of the safety and efficacy of the calcineurin inhibitor, pimecrolimus cream 1%, in adult patients with perioral dermatitis.
This study is not enrolling patients in the United States.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Pimecrolimus
- Pimecrolimus cream 1 %
- Drug: Placebo
- Vehicle cream (placebo)
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Pimecrolimus
- Placebo Comparator: 2
- Vehicle
Outcome Measures for this Clinical Trial
Primary Measures
- Reduction of the Perioral Dermatitis Severity Index
Secondary Measures
- Time to disease recurrence
- Response rates
- Patient's quality of life assessment
- Patient's disease severity assessment
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- clinically diagnosed perioral dermatitis associated or not associated with topical steroid use (the periorbital area may also be involved in addition to the perioral region)
- minimum severity score (PODSI) ≥ 4
- age 18 and older
Exclusion Criteria:
- Ongoing use of the following treatments is NOT allowed after the start of study drug:
- Oral tetracyclines, oral erythromycin, oral steroids and oral calcineurin inhibitors. All topical treatments of the face, including steroids, calcineurin inhibitors, metronidazole, tetracyclines, erythromycin and emollients (exception: DAC Basiscreme).
- Systemic immunosuppression
- History of malignancy of any organ system, treated or untreated, within the past 5 years
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Sponsor Information
Lead Sponsor: Novartis
Overall Clinical Trial Officials and Contacts
Novartis Pharma AG Study Chair Novartis
Additional Information
Information obtained from ClinicalTrials.gov on October 10, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00232115
Study ID Number: CASM981CDE15
ClinicalTrials.gov Identifier: NCT00232115
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Clinical Trials Authorship and Review
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