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Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

This study has been completed.
Information provided by:
Novartis Identifier:
First received: October 3, 2005
Last updated: January 15, 2008
Last verified: January 2008

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.

Condition Intervention Phase
Perioral Dermatitis Drug: Pimecrolimus Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Reduction of the Perioral Dermatitis Severity Index

Secondary Outcome Measures:
  • Time to disease recurrence
  • Response rates
  • Patient's quality of life assessment
  • Patient's disease severity assessment

Enrollment: 124
Study Start Date: September 2005
Study Completion Date: July 2006
Arms Assigned Interventions
Experimental: 1
Drug: Pimecrolimus
Pimecrolimus cream 1 %
Other Name: Elidel
Placebo Comparator: 2
Drug: Placebo
Vehicle cream (placebo)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

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
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Please refer to this study by its identifier: NCT00232115

Novartis Pharmaceuticals
Nürnberg, Germany
Sponsors and Collaborators
Study Chair: Novartis Pharma AG Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Identifier: NCT00232115     History of Changes
Other Study ID Numbers: CASM981CDE15
Study First Received: October 3, 2005
Last Updated: January 15, 2008

Keywords provided by Novartis:
Perioral Dermatitis, pimecrolimus cream

Additional relevant MeSH terms:
Dermatitis, Perioral
Skin Diseases
Facial Dermatoses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017