Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00232115

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 III

Drug Information available for: Pimecrolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

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
1: Experimental Pimecrolimus	Drug: Pimecrolimus Pimecrolimus cream 1 %
2: Placebo Comparator 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

More Information

Publications indexed to this study:

Schwarz T, Kreiselmaier I, Bieber T, Thaci D, Simon JC, Meurer M, Werfel T, Zuberbier T, Luger TA, Wollenberg A, Bräutigam M. A randomized, double-blind, vehicle-controlled study of 1% pimecrolimus cream in adult patients with perioral dermatitis. J Am Acad Dermatol. 2008 Jul;59(1):34-40. Epub 2008 May 7.

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CASM981CDE15
Study First Received:	October 3, 2005
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00232115
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:

Perioral Dermatitis, pimecrolimus cream

Study placed in the following topic categories:

Facial Dermatoses
Facies
Skin Diseases
Pimecrolimus

Tacrolimus
Dermatitis, Perioral
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents

Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 16, 2009