Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

Phase 3

Completed

• Conditions: Perioral Dermatitis
• Interventions: Drug: Pimecrolimus; Drug: Placebo

• Registration Number: NCT00232115
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-10-03
• Study First Submitted QC: 2005-10-03
• Study First Posted: 2005-10-04
• Study Completion: 2006-07
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-15
• Last Update Posted: 2008-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pimecrolimus	Pimecrolimus
2	Placebo	Vehicle

Primary Outcome Measures

Name	Time	Method
Reduction of the Perioral Dermatitis Severity Index

Secondary Outcome Measures

Name	Time	Method
Time to disease recurrence
Response rates
Patient's quality of life assessment
Patient's disease severity assessment

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇩🇪 Nürnberg, Germany