Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen (RALIB)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by University Hospital, Tours.
Recruitment status was Recruiting
Recruitment status was Recruiting
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 June 17, 2013