Treatment of Oral Erosive Lichen Planus With Pimecrolimus Cream

This study has been terminated.
Sponsor:
Information provided by:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT00321750
First received: May 2, 2006
Last updated: October 17, 2006
Last verified: May 2006
  Purpose

Background and hypothesis. Oral erosive lichen planus (OELP) is a severe form of mucosal lichen planus. Lesions often induce intense pain and limit feeding. Its course is chronic with flares and spontaneous remissions are rare. Treatment is difficult: topical steroids are usually used first but antimalarials, oral retinoids, systemic steroids, immunosuppressive drugs and even extracorporeal photochemotherapy can be necessary for treating severe forms. The need for novel therapies with less morbidity is obvious. Calcineurin inhibitors have a theoretical interest in treating OELP: this has been emphasized by several open studies performed with topical tacrolimus. The effectiveness of 1% pimecrolimus cream has been suggested by a few case reports and by one recent comparative study which confirmed the potential interest of topical pimecrolimus in treating OELP. The absorption of pimecrolimus through human mucosa is still unknown. Its application on ulcerative lesions such as OELP ones, could lead to significant systemic levels of the molecule.

Objective: To evaluate the efficacy of 1% pimecrolimus cream in treating oral erosive lichen planus (OELP) and to assess its tolerance.


Condition Intervention Phase
Oral Erosive Lichen Planus
Drug: 1% pimecrolimus cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Treatment of Oral Erosive Lichen Planus With 1% Pimecrolimus Cream: a Double Blind Randomized Prospective Trial With Measurement of Pimecrolimus Levels in the Blood

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • The efficacy of the treatment was quantified using a 12 points clinical score.
  • Blood level of pimecrolimus was analyzed at D0, D14 and D28.

Secondary Outcome Measures:
  • Side effects
  • Complete blood count

Estimated Enrollment: 14
Study Start Date: December 2004
Estimated Study Completion Date: April 2005
Detailed Description:

Background and hypothesis. Oral erosive lichen planus (OELP) is a severe form of mucosal lichen planus. Lesions often induce intense pain and limit feeding. Its course is chronic with flares and spontaneous remissions are rare. Treatment is difficult: topical steroids are usually used first but antimalarials, oral retinoids, systemic steroids, immunosuppressive drugs and even extracorporeal photochemotherapy can be necessary for treating severe forms. The need for novel therapies with less morbidity is obvious. Calcineurin inhibitors have a theoretical interest in treating OELP: this has been emphasized by several open studies performed with topical tacrolimus. The effectiveness of 1% pimecrolimus cream has been suggested by a few case reports and by one recent comparative study which confirmed the potential interest of topical pimecrolimus in treating OELP. The absorption of pimecrolimus through human mucosa is still unknown. Its application on ulcerative lesions such as OELP ones, could lead to significant systemic levels of the molecule.

Objective: To evaluate the efficacy of 1% pimecrolimus cream in treating oral erosive lichen planus (OELP) and to assess its tolerance.

Design: Double blind randomized trial with placebo control.

Settings: Outpatients of the Department of Dermatology of the University hospital of Nice, France.

Patients: Fourteen consecutive patients with OELP confirmed by histological examination and with a clinical score superior to 3. 1% pimecrolimus cream or its vehicle were applied on ulcerated lesions twice a day for 4 weeks.

Main outcome measures; the efficacy of the treatment was quantified using a 12 points clinical score. Blood level of pimecrolimus was analyzed at D0, D14 and D28.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmation of the diagnosis of OELP by histological examination and a clinical score superior to 3

Exclusion Criteria:

  • Patients under 18 years
  • Pregnancy or breast feeding
  • Malignancy
  • Severe or recurrent infections
  • Uncontrolled chronic disorders
  • Congenital or acquired immunosuppression and concomitant treatments potentially effective on OELP such as antimalarials, oral retinoids, steroids or immunosuppressive drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321750

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Thierry D Passeron, MD CHU de Nice
Study Director: Jean-Philippe Lacour, MD CHU de Nice
Study Chair: Jean-Paul Ortonne, MD CHU de Nice
Study Chair: Eric Fontas, MD CHU de Nice
  More Information

No publications provided by Centre Hospitalier Universitaire de Nice

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00321750     History of Changes
Other Study ID Numbers: CASM981CFR01
Study First Received: May 2, 2006
Last Updated: October 17, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nice:
Oral erosive lichen planus
pimecrolimus cream

Additional relevant MeSH terms:
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014