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

R

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

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%

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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