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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
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 2, 2006
    Last Updated
    October 17, 2006
    Sponsor
    Centre Hospitalier Universitaire de Nice
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    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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