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
  Purpose

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.


Condition Intervention Phase
Oral Lichen Planus
Drug: TOPICAL SIROLIMUS (RAPAMUNE*)
Drug: TOPICAL BETAMETHASONE 0.05%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Topical Rapamycin in Treatment of Chronic Erosive Oral Lichen Planus. Double Blind Randomised Controlled Trial Rapamycin vs Topical Steroids

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • COMPLETE CLEARING OF ORAL EROSIVE LESIONS [ Time Frame: THREE MONTHS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • REGRESSION OF EROSIVE SURFACE AREA [ Time Frame: THREE MONTHS ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: February 2008
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01061853

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

No publications provided

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01061853     History of Changes
Other Study ID Numbers: PHRN06-LV/RALIB, 2007-000152-14
Study First Received: February 2, 2010
Last Updated: October 15, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Tours:
Oral lichen planus
chronic inflammatory
mucous membranes
erosive lesions

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Sirolimus
Everolimus
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 31, 2014