Back to resultsPimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis
Primary Purpose
Perioral Dermatitis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Pimecrolimus
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Perioral Dermatitis focused on measuring Perioral Dermatitis, pimecrolimus cream
Eligibility 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
Sites / Locations
- Novartis Pharmaceuticals
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Pimecrolimus
Vehicle
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00232115
Brief Title
Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis
Official Title
Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioral Dermatitis
Keywords
Perioral Dermatitis, pimecrolimus cream
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
124 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Pimecrolimus
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Vehicle
Intervention Type
Drug
Intervention Name(s)
Pimecrolimus
Other Intervention Name(s)
Elidel
Intervention Description
Pimecrolimus cream 1 %
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle cream (placebo)
Primary Outcome Measure Information:
Title
Reduction of the Perioral Dermatitis Severity Index
Secondary Outcome Measure Information:
Title
Time to disease recurrence
Title
Response rates
Title
Patient's quality of life assessment
Title
Patient's disease severity assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharma AG
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
Nürnberg
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
18462835
Citation
Schwarz T, Kreiselmaier I, Bieber T, Thaci D, Simon JC, Meurer M, Werfel T, Zuberbier T, Luger TA, Wollenberg A, Brautigam 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. doi: 10.1016/j.jaad.2008.03.043. Epub 2008 May 7.
Results Reference
derived
Learn more about this trial
Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis
We'll reach out to this number within 24 hrs