Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

Perioral Dermatitis Clinical Trial

Official title:

Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232115
• Other study ID #: CASM981CDE15
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2005
• Last updated: January 15, 2008
• Start date: September 2005
• Est. completion date: July 2006

Study information

• Verified date: January 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: July 2006
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Eczema
• Perioral Dermatitis

Intervention

Drug:
• Pimecrolimus
Pimecrolimus cream 1 %
• Placebo
Vehicle cream (placebo)

Locations

Country	Name	City	State
Germany	Novartis Pharmaceuticals	Nürnberg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of the Perioral Dermatitis Severity Index
Secondary	Time to disease recurrence
Secondary	Response rates
Secondary	Patient's quality of life assessment
Secondary	Patient's disease severity assessment