Perioral Dermatitis
Conditions
Keywords
Perioral Dermatitis, pimecrolimus cream
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.
Interventions
DRUGPimecrolimus
Pimecrolimus cream 1 %
DRUGPlacebo
Vehicle cream (placebo)
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of the Perioral Dermatitis Severity Index | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient's disease severity assessment | — |
| Time to disease recurrence | — |
| Response rates | — |
| Patient's quality of life assessment | — |
Countries
Germany
Outcome results
None listed