Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

Novartis

Status and phase: Completed; Phase 3

Conditions: Perioral Dermatitis

Treatments: Drug: Pimecrolimus; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00232115

CASM981CDE15

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

124 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Pimecrolimus

Treatment:

Drug: Pimecrolimus

2

Placebo Comparator group

Description:

Vehicle

Treatment:

Drug: Placebo