Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00232115
• Collaborator: (none)
• Enrollment: 124
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 12.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perioral Dermatitis	Drug: Pimecrolimus; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 124 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis
• Study Start Date: Sep 1, 2005
• Actual Study Completion Date: Jul 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Pimecrolimus	Drug: Pimecrolimus; Pimecrolimus cream 1 %; Other Names: Elidel
Placebo Comparator: 2 Vehicle	Drug: Placebo; Vehicle cream (placebo)

Outcome Measures

Primary Outcome Measures

1. Reduction of the Perioral Dermatitis Severity Index []

Secondary Outcome Measures

1. Time to disease recurrence []

2. Response rates []

3. Patient's quality of life assessment []

4. Patient's disease severity assessment []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Pharmaceuticals	Nürnberg		Germany

Sponsors and Collaborators

• Novartis

Investigators

• Study Chair: Novartis Pharma AG, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00232115
• Other Study ID Numbers: CASM981CDE15
• First Posted: Oct 4, 2005
• Last Update Posted: Jan 17, 2008
• Last Verified: Jan 1, 2008

• Keywords provided by , ,: Perioral Dermatitis, pimecrolimus cream
• Additional relevant MeSH terms: Dermatitis; Dermatitis, Perioral; Pimecrolimus

Study Results

No Results Posted as of Jan 17, 2008