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Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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