Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen (RALIB)
This study is currently recruiting participants.
Verified May 2011 by University Hospital, Tours
Sponsor:
University Hospital, Tours
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01061853
First received: February 2, 2010
Last updated: May 2, 2011
Last verified: May 2011
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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 BETHAMETHASONE 0.05% |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Efficacy of Topical Rapamycin in Tne Treatment of Chronic Erosive Oral Lichen Planus. Double Blind Randomised Controlled Trial Rapamycin vs Ntopical 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 ]
| Estimated Enrollment: | 198 |
| Study Start Date: | February 2008 |
| Estimated Primary Completion Date: | February 2013 (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 BETHAMETHASONE 0.05%
APPLICATION ON THE LESIONS OF TOPICAL BETHAMETHASONE (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 Treated By Rapamycin
- Non Child Bearing Or Breast Feeding Woman
- Patient Who Cannot Be Treated By Rapamycin Or Bethamethasone
- Chronic Renal Insufficiency (Creatinin Clearance < 40ml/Mn)
- Ongoing Treatment By Topical Calcineurins 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061853
Contacts
| Contact: Loïc VAILLANT, MD | +33(0)2 47 47 90 80 | vaillant@med.univ-tours.fr |
| Contact: Brigitte HÜTTENBERGER, MD | +33(0)2 47 47 83 47 | b.huttenberger@chu-tours.fr |
Locations
| France | |
| University Hospital of REIMS | Recruiting |
| Reims, Marne, France, F-51092 | |
| Contact: Philippe BERNARD, MD-PHD 33(0)326784368 pbernard@chu-reims.fr | |
| Principal Investigator: Philippe BERNARD, MD-PHD | |
| Hospital Avicenne-APHP | Recruiting |
| Bobigny, France, 93009 | |
| Contact: Catherine PROST, MD +33(0)1 48 95 77 07 prostsquarcioni.cath@free.fr | |
| Contact: Christelle LE ROUX-VILLET, MD +33(0)1 48 95 77 07 christelle.le-roux@avc.aphp.fr | |
| Principal Investigator: Liliane LAROCHE, MD | |
| Sub-Investigator: Catherine PROST, MD | |
| Sub-Investigator: Francis PASCAL, MD | |
| Sub-Investigator: Christelle LE ROUX-VILLET, MD | |
| University Hospital of Bordeaux-St.André | Recruiting |
| Bordeaux, France, 33075 | |
| Contact: Alain TAÏEB, MD +33(0)5 56 79 47 05 alain.taieb@chu-bordeaux.fr | |
| Contact: Franck BORALEVI, MD +33(0)5 56 79 49 63 franck.boralevi@chu-bordeaux.fr | |
| Principal Investigator: Alain TAÏEB, MD | |
| Sub-Investigator: Jean-Christophe FRICAIN, MD | |
| Sub-Investigator: Franck BORALEVI, MD | |
| University Hospital of Lille | Recruiting |
| Lille, France, 59037 | |
| Contact: Alexandre BRYGO, MD +33(0)3 20 44 63 76 alxbrygo@yahoo.fr | |
| Principal Investigator: Emmanuel DELAPORTE, MD | |
| Sub-Investigator: Alexandre BRYGO, MD | |
| University Hospital of Nice | Recruiting |
| Nice, France, 06202 | |
| Contact: Jean-Philippe DELACOUR, MD 33 (0)4 92 03 60 02 jean-philippe.lacour@unice.fr | |
| Contact: Thierry PASSERON, MD 33 (0)4 92 03 60 02 passeron@unice.fr | |
| Sub-Investigator: Thierry PASSERON, MD | |
| Principal Investigator: Jean-Philippe DELACOUR, MD | |
| Hospital Tenon-APHP | Not yet recruiting |
| Paris, France, 75970 | |
| Contact: Camille FRANCES, MD +33(0)1 56 01 76 63 camille.frances@tnn.aphp.fr | |
| Contact: Belen EGUIA, MD +33(0)1 56 01 67 06 belen52@hotmail.com | |
| Principal Investigator: Camille FRANCES, MD | |
| Sub-Investigator: Belen EGUIA, MD | |
| Hospital La Pitié-Salpêtrière APHP | Recruiting |
| Paris, France, 75651 | |
| Contact: Scarlette AGBO-GODEAU, MD +33(0)1 42 16 13 11 scarlette.agbo-godeau@psl.aphp.fr | |
| Principal Investigator: Scarlette AGBO-GODEAU, MD | |
| Sub-Investigator: Lotfi BEN SLAMA, MD | |
| Hospital Saint Louis-APHP | Recruiting |
| Paris, France, 75475 | |
| Contact: Francis PASCAL, MD +33(0)142 49 91 91 docfpascal@club-internet.fr | |
| Contact: Agnes FLAVIAN, MD +33(0)1 46 28 98 10 fla.thierry@wanadoo.fr | |
| Principal Investigator: Francis PASCAL, MD | |
| Sub-Investigator: Catherine PROST, MD | |
| Sub-Investigator: Agnes FLAVIAN, MD | |
| University hospital of Tours | Recruiting |
| Tours, France, 37044 | |
| Contact: Brigitte HÜTTENBERGER, MD +33 (0) 2 47 47 90 73 b.huttenberger@chu-tours.fr | |
| Sub-Investigator: Brigitte HÜTTENBERGER, MD | |
| Principal Investigator: Loïc VAILLANT, MD | |
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, CHRU-TOURS,Direction de la Recherche |
| ClinicalTrials.gov Identifier: | NCT01061853 History of Changes |
| Other Study ID Numbers: | PHRN06-LV/RALIB, 2007-000152-14;A70211-25 |
| Study First Received: | February 2, 2010 |
| Last Updated: | May 2, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Tours:
|
ORAL LICHEN PLANUS TREATMENT |
Additional relevant MeSH terms:
|
Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Skin Diseases, Papulosquamous Skin Diseases Mouth Diseases Stomatognathic Diseases Sirolimus Everolimus Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antifungal Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on October 17, 2012
