TerminatedPhase 3

Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen

Stopped: Per protocol intermediate analyses of 76 patients and enrollment difficulties.

France76 participantsStarted 2008-02

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

COMPLETE CLEARING OF ORAL EROSIVE LESIONS

Timeframe: THREE MONTHS

Trial details

NCT IDNCT01061853

SponsorUniversity Hospital, Tours

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-11

View on ClinicalTrials.gov More Oral Lichen Planus trials