Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3

Details

• Lead Sponsor: Novartis
• Treatments: Pimecrolimus; Tacrolimus

Criteria

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