Status:
COMPLETED
Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis
Lead Sponsor:
Novartis
Conditions:
Perioral Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT00232115
Start Date
September 1 2005
End Date
July 1 2006
Last Update
January 17 2008
Active Locations (1)
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1
Novartis Pharmaceuticals
Nuremberg, Germany