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

October 15, 2013 updated by: University Hospital, Tours

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France, 93009
        • Hospital Avicenne-APHP
      • Bordeaux, France, 33075
        • University Hospital of Bordeaux-St.André
      • Lille, France, 59037
        • University Hospital of Lille
      • Nice, France, 06202
        • University Hospital of Nice
      • Paris, France, 75475
        • Hospital Saint Louis-APHP
      • Paris, France, 75651
        • Hospital La Pitié-Salpêtrière APHP
      • Paris, France, 75970
        • Hospital Tenon-APHP
      • Tours, France, 37044
        • University hospital of Tours
    • Marne
      • Reims, Marne, France, F-51092
        • University Hospital of Reims

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: T
TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE
Drug: TOPICAL SIROLIMUS (RAPAMUNE*)
APPLICATION ON THE LESIONS OF TOPICAL SIROLIMUS (RAPAMUNE*)1mg/ml bid during 3 months
Active Comparator: C
TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL
Drug: TOPICAL BETAMETHASONE 0.05%
APPLICATION ON THE LESIONS OF TOPICAL BETAMETHASONE (DIPROLENE*)0.05% bid during 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
COMPLETE CLEARING OF ORAL EROSIVE LESIONS
Time Frame: THREE MONTHS
THREE MONTHS

Secondary Outcome Measures

Outcome Measure
Time Frame
REGRESSION OF EROSIVE SURFACE AREA
Time Frame: THREE MONTHS
THREE MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

February 2, 2010

First Posted (Estimate)

February 3, 2010

Study Record Updates

Last Update Posted (Estimate)

October 16, 2013

Last Update Submitted That Met QC Criteria

October 15, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRN06-LV/RALIB
  • 2007-000152-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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