Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen

Phase 3

Terminated

• Conditions: Oral Lichen Planus
• Interventions: Drug: TOPICAL BETAMETHASONE 0.05%; Drug: TOPICAL SIROLIMUS (RAPAMUNE*)

• Registration Number: NCT01061853
• Lead Sponsor: University Hospital, Tours

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2010-02-02
• Study First Submitted QC: 2010-02-02
• Study First Posted: 2010-02-03
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-15
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	TOPICAL BETAMETHASONE 0.05%	TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL
T	TOPICAL SIROLIMUS (RAPAMUNE*)	TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE

Primary Outcome Measures

Name	Time	Method
COMPLETE CLEARING OF ORAL EROSIVE LESIONS	THREE MONTHS

Secondary Outcome Measures

Name	Time	Method
REGRESSION OF EROSIVE SURFACE AREA	THREE MONTHS

Trial Locations

Locations (9)

Hospital Tenon-APHP; 🇫🇷 Paris, France

University Hospital of Nice; 🇫🇷 Nice, France

University Hospital of REIMS; 🇫🇷 Reims, Marne, France

University Hospital of Bordeaux-St.André; 🇫🇷 Bordeaux, France

University Hospital of Lille; 🇫🇷 Lille, France

Hospital Avicenne-APHP; 🇫🇷 Bobigny, France

University hospital of Tours; 🇫🇷 Tours, France

Hospital La Pitié-Salpêtrière APHP; 🇫🇷 Paris, France

Hospital Saint Louis-APHP; 🇫🇷 Paris, France