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

Regional University Hospital Center (CHRU)

Status and phase: Terminated; Phase 3

Conditions: Oral Lichen Planus

Treatments: Drug: TOPICAL SIROLIMUS (RAPAMUNE*); Drug: TOPICAL BETAMETHASONE 0.05%

Study type: Interventional

Funder types: Other

Identifiers

NCT01061853

2007-000152-14 (EudraCT Number)

PHRN06-LV/RALIB

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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76 participants in 2 patient groups

T

Experimental group

Description:

TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE

Treatment:

Drug: TOPICAL SIROLIMUS (RAPAMUNE*)

C

Active Comparator group

Description:

TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL

Treatment:

Drug: TOPICAL BETAMETHASONE 0.05%