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

May 2, 2006
October 17, 2006
December 2004
Not Provided
  • The efficacy of the treatment was quantified using a 12 points clinical score.
  • Blood level of pimecrolimus was analyzed at D0, D14 and D28.
Same as current
Complete list of historical versions of study NCT00321750 on ClinicalTrials.gov Archive Site
  • Side effects
  • Complete blood count
Same as current
Not Provided
Not Provided
 
Treatment of Oral Erosive Lichen Planus With Pimecrolimus Cream
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Oral Erosive Lichen Planus
Drug: 1% pimecrolimus cream
Not Provided
Passeron T, Lacour JP, Fontas E, Ortonne JP. Treatment of oral erosive lichen planus with 1% pimecrolimus cream: a double-blind, randomized, prospective trial with measurement of pimecrolimus levels in the blood. Arch Dermatol. 2007 Apr;143(4):472-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
14
April 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00321750
CASM981CFR01
Not Provided
Not Provided
Centre Hospitalier Universitaire de Nice
Not Provided
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
Centre Hospitalier Universitaire de Nice
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP