NCT00232115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

January 17, 2008

Status Verified

January 1, 2008

First QC Date

October 3, 2005

Last Update Submit

January 15, 2008

Conditions

Perioral Dermatitis

Keywords

Perioral Dermatitis, pimecrolimus cream

Outcome Measures

Primary Outcomes (1)

  • Reduction of the Perioral Dermatitis Severity Index

Secondary Outcomes (4)

  • Time to disease recurrence

  • Response rates

  • Patient's quality of life assessment

  • Patient's disease severity assessment

Study Arms (2)

1

EXPERIMENTAL

Pimecrolimus

Drug: Pimecrolimus

2

PLACEBO COMPARATOR

Vehicle

Drug: Placebo

Interventions

PimecrolimusDRUG

Pimecrolimus cream 1 %

Also known as: Elidel
1
PlaceboDRUG

Vehicle cream (placebo)

2

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Pharmaceuticals

Nuremberg, Germany

Location

Related Publications (1)

  • 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.

    PMID: 18462835DERIVED

MeSH Terms

Conditions

Dermatitis, Perioral

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesFacial Dermatoses

Study Officials

  • Novartis Pharma AG

    Novartis Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 4, 2005

Study Start

September 1, 2005

Study Completion

July 1, 2006

Last Updated

January 17, 2008

Record last verified: 2008-01

Locations

DE(1)