Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis
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...
Brief Summary
Official Title: “Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis”
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharma AG Study Chair Novartis Pharmaceuticals
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
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 content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.
The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00232115
