Treatment of Oral Erosive Lichen Planus With Pimecrolimus Cream
Primary Purpose
Oral Erosive Lichen Planus
Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
1% pimecrolimus cream
Sponsored by
About this trial
This is an interventional treatment trial for Oral Erosive Lichen Planus focused on measuring Oral erosive lichen planus, pimecrolimus cream
Eligibility 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
Sites / Locations
Outcomes
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
Full Information
NCT ID
NCT00321750
First Posted
May 2, 2006
Last Updated
October 17, 2006
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT00321750
Brief Title
Treatment of Oral Erosive Lichen Planus With Pimecrolimus Cream
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2006
Overall Recruitment Status
Terminated
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Erosive Lichen Planus
Keywords
Oral erosive lichen planus, pimecrolimus cream
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
14 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
1% pimecrolimus cream
Primary Outcome Measure Information:
Title
The efficacy of the treatment was quantified using a 12 points clinical score.
Title
Blood level of pimecrolimus was analyzed at D0, D14 and D28.
Secondary Outcome Measure Information:
Title
Side effects
Title
Complete blood count
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry D Passeron, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Philippe Lacour, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jean-Paul Ortonne, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Eric Fontas, MD
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
17438179
Citation
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. doi: 10.1001/archderm.143.4.472.
Results Reference
derived
Learn more about this trial
Treatment of Oral Erosive Lichen Planus With Pimecrolimus Cream
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