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Completed

NCT Number: NCT00130572

Efficacy of Elidel Cream on Erosive Oral Lichen Planus

The purpose of this study is to investigate whether topical applied pimecrolimus will lead to improvement of erosive oral lichen planus. This effect will be monitored by reduction of erosive mucosal area and reduction of patient's pain symptoms.

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Key information

Conditions

Lichen Planus, Oral Lichen Planus Lichenoid Eruptions Mouth Diseases Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital, Department of Dermatology

Tübingen, 72076, Germany

About this study

Oral lichen planus is a mucosal inflammatory disease of unknown origin. It can be very painful especially if erosions appear on the oral mucosa.

In this study the efficacy of pimecrolimus compared to placebo in treatment of erosive oral lichen planus will be investigated. To this end the subjective pain and the amount of affected mucosa will be monitored before and after treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinically and histologically confirmed diagnosis of erosive oral lichen planus
  • Spontaneous or meal related oral pain
  • No topical therapy 2 weeks prior to study start
  • No systemic therapy 4 weeks prior to study start
  • Signed informed consent

Exclusion criteria

  • Pregnant or breast-feeding women
  • Known allergy to macrolide antibiotics
  • Known current active malignant disease or in patient's history
  • Known immunodeficiency or HIV infection
  • Participation at another clinical trial within the last 6 months

Treatment and study plan

pimecrolimus

Drug

Primary outcomes

  1. Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment

Secondary outcomes

  1. Patient's and investigator's global assessment after 4 and 8 weeks

  2. Pimecrolimus blood level after 4 weeks

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Official study title

Randomized Placebo-Controlled Clinical Pilot Trial Regarding the Efficacy of Elidel Cream on Erosive Oral Lichen Planus

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Aug 15, 2005
Registry last updated
May 23, 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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