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OpenTrials
Completed

NCT Number: NCT00232115

Pimecrolimus Cream 1% in Adult Patients With Perioral Dermatitis

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.

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Key information

Conditions

Perioral Dermatitis Dermatitis Dermatitis, Perioral Facial Dermatoses Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

Nuremberg, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pimecrolimus

Drug

Pimecrolimus cream 1 %

Other names: Elidel

Placebo

Drug

Vehicle cream (placebo)

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2005
Study completion
2006
First posted
Oct 4, 2005
Registry last updated
Jan 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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