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Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen

Efficacy of Topical Rapamycin in Treatment of Chronic Erosive Oral Lichen Planus. Double Blind Randomised Controlled Trial Rapamycin vs Topical Steroids

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01061853
Acronym
RALIB
Enrollment
76
Registered
2010-02-03
Start date
2008-02-29
Completion date
2012-11-30
Last updated
2013-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Lichen Planus

Keywords

Oral lichen planus, chronic inflammatory, mucous membranes, erosive lesions

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.

Interventions

DRUGTOPICAL SIROLIMUS (RAPAMUNE*)

APPLICATION ON THE LESIONS OF TOPICAL SIROLIMUS (RAPAMUNE\*)1mg/ml bid during 3 months

DRUGTOPICAL BETAMETHASONE 0.05%

APPLICATION ON THE LESIONS OF TOPICAL BETAMETHASONE (DIPROLENE\*)0.05% bid during 3 months

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
COMPLETE CLEARING OF ORAL EROSIVE LESIONSTHREE MONTHS

Secondary

MeasureTime frame
REGRESSION OF EROSIVE SURFACE AREATHREE MONTHS

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026