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Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00232115
First received: October 3, 2005
Last updated: January 15, 2008
Last verified: January 2008
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

Resource links provided by NLM:

U.S. FDA Resources

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
Pimecrolimus
 Drug: Pimecrolimus
Pimecrolimus cream 1 %
Other Name: Elidel
Placebo Comparator: 2
Vehicle
 Drug: Placebo
Vehicle cream (placebo)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00232115

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

No publications provided by Novartis

Additional 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
Study First Received: October 3, 2005
Last Updated: January 15, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on June 17, 2013