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Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00232115
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : January 17, 2008
Sponsor:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment Phase
Perioral Dermatitis Drug: Pimecrolimus Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis
Study Start Date : September 2005
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Pimecrolimus
Drug: Pimecrolimus
Pimecrolimus cream 1 %
Other Name: Elidel
Placebo Comparator: 2
Vehicle
Drug: Placebo
Vehicle cream (placebo)


Outcome Measures

Primary Outcome Measures :
  1. Reduction of the Perioral Dermatitis Severity Index

Secondary Outcome Measures :
  1. Time to disease recurrence
  2. Response rates
  3. Patient's quality of life assessment
  4. Patient's disease severity assessment

Eligibility Criteria

Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232115


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00232115     History of Changes
Other Study ID Numbers: CASM981CDE15
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: January 17, 2008
Last Verified: January 2008

Keywords provided by Novartis:
Perioral Dermatitis, pimecrolimus cream

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Perioral
Skin Diseases
Facial Dermatoses
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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