Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Tours
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Everolimus; Sirolimus

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