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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014