Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen (RALIB)

This study has been terminated.
(Per protocol intermediate analyses of 76 patients and enrollment difficulties.)
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01061853
First received: February 2, 2010
Last updated: October 15, 2013
Last verified: October 2013

February 2, 2010
October 15, 2013
February 2008
November 2012   (final data collection date for primary outcome measure)
COMPLETE CLEARING OF ORAL EROSIVE LESIONS [ Time Frame: THREE MONTHS ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01061853 on ClinicalTrials.gov Archive Site
REGRESSION OF EROSIVE SURFACE AREA [ Time Frame: THREE MONTHS ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen
Efficacy of Topical Rapamycin in Treatment of Chronic Erosive Oral Lichen Planus. Double Blind Randomised Controlled Trial Rapamycin vs Topical Steroids

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Oral Lichen Planus
  • Drug: TOPICAL SIROLIMUS (RAPAMUNE*)
    APPLICATION ON THE LESIONS OF TOPICAL SIROLIMUS (RAPAMUNE*)1mg/ml bid during 3 months
  • Drug: TOPICAL BETAMETHASONE 0.05%
    APPLICATION ON THE LESIONS OF TOPICAL BETAMETHASONE (DIPROLENE*)0.05% bid during 3 months
  • Experimental: T
    TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE
    Intervention: Drug: TOPICAL SIROLIMUS (RAPAMUNE*)
  • Active Comparator: C
    TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL
    Intervention: Drug: TOPICAL BETAMETHASONE 0.05%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
76
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01061853
PHRN06-LV/RALIB, 2007-000152-14
Yes
University Hospital, Tours
University Hospital, Tours
Institut National de la Santé Et de la Recherche Médicale, France
Study Director: Loïc VAILLANT, MD Centre 1-TOURS
Principal Investigator: Camille FRANCES, MD Centre-2 Tenon
Principal Investigator: Scarlette AGBO-GODEAU, MD Centre-3 La Pitié-Salpêtrière
Principal Investigator: Liliane LAROCHE, MD Centre-4 Avicenne
Principal Investigator: Francis PASCAL, MD Centre-5 St-Louis
Principal Investigator: Emmanuel DELAPORTE, MD Centre-6 Lille
Principal Investigator: Alain TAÏEB, MD Centre-7 Bordeaux
Principal Investigator: Jean-Philippe DELACOUR, MD Centre -8 Nice
Principal Investigator: Philippe BERNARD, MD-PHD Centre-9 REIMS
University Hospital, Tours
October 2013

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