Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen (RALIB)
Primary Purpose
Oral Lichen Planus
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
TOPICAL SIROLIMUS (RAPAMUNE*)
TOPICAL BETAMETHASONE 0.05%
Sponsored by
About this trial
This is an interventional treatment trial for Oral Lichen Planus focused on measuring Oral lichen planus, chronic inflammatory, mucous membranes, erosive lesions
Eligibility Criteria
Inclusion Criteria:
- Oral Lichen Planus
- Oral Erosive Area More Than 1cm²
- Lichen Planus Pathologically Proven
Exclusion Criteria:
- No Previous Treatment by Rapamycin
- Non Child Bearing Or Breast Feeding Woman
- Patient Who Cannot Be Treated By Rapamycin Or Betamethasone
- Chronic Renal Insufficiency (Creatinin Clearance < 40ml/Mn)
- Ongoing Treatment By Topical Calcineurin Inhibitors Or Systemic Steroids Or Retinoids Or Systemic Immunosuppressors Or Thalidomide Or Griseofulvin Or Antimalarials
- Cholesterolemia >7.8 Mmol/L Or Hypertriglyceridemia >3.95mmol/L Non Responsive To Medical Treatments
- Leucopenia (<3000/Mm3)
- Thrombopenia (<100 000/Mm3)
- Hypertransaminasemia (>3n)
- Hypersensitivity To Macrolides
Sites / Locations
- University Hospital of REIMS
- Hospital Avicenne-APHP
- University Hospital of Bordeaux-St.André
- University Hospital of Lille
- University Hospital of Nice
- Hospital Saint Louis-APHP
- Hospital La Pitié-Salpêtrière APHP
- Hospital Tenon-APHP
- University hospital of Tours
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
T
C
Arm Description
TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE
TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL
Outcomes
Primary Outcome Measures
COMPLETE CLEARING OF ORAL EROSIVE LESIONS
Secondary Outcome Measures
REGRESSION OF EROSIVE SURFACE AREA
Full Information
NCT ID
NCT01061853
First Posted
February 2, 2010
Last Updated
October 15, 2013
Sponsor
University Hospital, Tours
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT01061853
Brief Title
Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen
Acronym
RALIB
Official Title
Efficacy of Topical Rapamycin in Treatment of Chronic Erosive Oral Lichen Planus. Double Blind Randomised Controlled Trial Rapamycin vs Topical Steroids
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
Per protocol intermediate analyses of 76 patients and enrollment difficulties.
Study Start Date
February 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine wether topical rapamycin is more efficient than topical steroids in the treatment of chronic erosive lichen planus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
Oral lichen planus, chronic inflammatory, mucous membranes, erosive lesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
T
Arm Type
Experimental
Arm Description
TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE
Arm Title
C
Arm Type
Active Comparator
Arm Description
TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL
Intervention Type
Drug
Intervention Name(s)
TOPICAL SIROLIMUS (RAPAMUNE*)
Intervention Description
APPLICATION ON THE LESIONS OF TOPICAL SIROLIMUS (RAPAMUNE*)1mg/ml bid during 3 months
Intervention Type
Drug
Intervention Name(s)
TOPICAL BETAMETHASONE 0.05%
Intervention Description
APPLICATION ON THE LESIONS OF TOPICAL BETAMETHASONE (DIPROLENE*)0.05% bid during 3 months
Primary Outcome Measure Information:
Title
COMPLETE CLEARING OF ORAL EROSIVE LESIONS
Time Frame
THREE MONTHS
Secondary Outcome Measure Information:
Title
REGRESSION OF EROSIVE SURFACE AREA
Time Frame
THREE MONTHS
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Oral Lichen Planus
Oral Erosive Area More Than 1cm²
Lichen Planus Pathologically Proven
Exclusion Criteria:
No Previous Treatment by Rapamycin
Non Child Bearing Or Breast Feeding Woman
Patient Who Cannot Be Treated By Rapamycin Or Betamethasone
Chronic Renal Insufficiency (Creatinin Clearance < 40ml/Mn)
Ongoing Treatment By Topical Calcineurin Inhibitors Or Systemic Steroids Or Retinoids Or Systemic Immunosuppressors Or Thalidomide Or Griseofulvin Or Antimalarials
Cholesterolemia >7.8 Mmol/L Or Hypertriglyceridemia >3.95mmol/L Non Responsive To Medical Treatments
Leucopenia (<3000/Mm3)
Thrombopenia (<100 000/Mm3)
Hypertransaminasemia (>3n)
Hypersensitivity To Macrolides
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loïc VAILLANT, MD
Organizational Affiliation
Centre 1-TOURS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Camille FRANCES, MD
Organizational Affiliation
Centre-2 Tenon
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scarlette AGBO-GODEAU, MD
Organizational Affiliation
Centre-3 La Pitié-Salpêtrière
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Liliane LAROCHE, MD
Organizational Affiliation
Centre-4 Avicenne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Francis PASCAL, MD
Organizational Affiliation
Centre-5 St-Louis
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Emmanuel DELAPORTE, MD
Organizational Affiliation
Centre-6 Lille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alain TAÏEB, MD
Organizational Affiliation
Centre-7 Bordeaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Philippe DELACOUR, MD
Organizational Affiliation
Centre -8 Nice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe BERNARD, MD-PHD
Organizational Affiliation
Centre-9 REIMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of REIMS
City
Reims
State/Province
Marne
ZIP/Postal Code
F-51092
Country
France
Facility Name
Hospital Avicenne-APHP
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
University Hospital of Bordeaux-St.André
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
University Hospital of Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
University Hospital of Nice
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Hospital Saint Louis-APHP
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hospital La Pitié-Salpêtrière APHP
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hospital Tenon-APHP
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
University hospital of Tours
City
Tours
ZIP/Postal Code
37044
Country
France
12. IPD Sharing Statement
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Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen
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