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CompletedNCT00232115Updated Jan 17, 2008

Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

A Phase 3 interventional study of Pimecrolimus and Placebo in Perioral Dermatitis, sponsored by Novartis. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-01-17.

Sponsored by Novartis · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Perioral Dermatitis

Keywords

  • Perioral Dermatitis, pimecrolimus cream
03

In context

Lead sponsor

Novartis is the lead sponsor of 714 studies on the registry; none are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
124 participants (actual)

Study arms

  • Experimental
    1

    Pimecrolimus

    Drug: Pimecrolimus

  • Placebo comparator
    2

    Vehicle

    Drug: Placebo

Interventions

  • DrugPimecrolimus

    Pimecrolimus cream 1 %

    Also known as: Elidel

  • DrugPlacebo

    Vehicle cream (placebo)

06

What researchers measure

Primary outcomes

  1. Reduction of the Perioral Dermatitis Severity Index

Secondary outcomes

  1. Time to disease recurrence

  2. Response rates

  3. Patient's quality of life assessment

  4. Patient's disease severity assessment

07

Study locations

1 site
  • Novartis Pharmaceuticals
    Nuremberg, Germany
08

References and documents

Publications

  • 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. PubMed 18462835 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2005 and a completion of Jul 2006. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 3, 2005
First posted
Oct 4, 2005
Start
Sep 2005
CompletionActual
Jul 2006
Last update
Jan 17, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00232115
Lead sponsor
Novartis
First posted
Oct 4, 2005
Start date
Sep 2005
Completion
Jul 2006
Last update
Jan 17, 2008

Study contacts

Novartis Pharma AG
study chair · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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