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Clinical Trials/NCT00232115
NCT00232115
Completed
Phase 3

Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

Novartis1 site in 1 country124 target enrollmentSeptember 2005
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ConditionsPerioral Dermatitis
InterventionsPimecrolimusPlacebo
DrugsPimecrolimusPlacebo

Overview

Phase
Phase 3
Intervention
Pimecrolimus
Conditions
Perioral Dermatitis
Sponsor
Novartis
Enrollment
124
Locations
1
Primary Endpoint
Reduction of the Perioral Dermatitis Severity Index
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2005
End Date
July 2006
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Novartis

Eligibility 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

Arms & Interventions

1

Pimecrolimus

Intervention: Pimecrolimus

2

Vehicle

Intervention: Placebo

Outcomes

Primary Outcomes

Reduction of the Perioral Dermatitis Severity Index

Secondary Outcomes

  • Time to disease recurrence
  • Response rates
  • Patient's quality of life assessment
  • Patient's disease severity assessment

Study Sites (1)

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