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

Primary Purpose

Oral Lichen Planus

Status

Terminated

Phase

Phase 3

Locations

France

Study Type

Interventional

Intervention

TOPICAL SIROLIMUS (RAPAMUNE*)

TOPICAL BETAMETHASONE 0.05%

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring Oral lichen planus, chronic inflammatory, mucous membranes, erosive lesions

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE

TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL

Outcomes

Primary Outcome Measures

COMPLETE CLEARING OF ORAL EROSIVE LESIONS

Secondary Outcome Measures

REGRESSION OF EROSIVE SURFACE AREA

Full Information

NCT ID

NCT01061853

First Posted

February 2, 2010

Last Updated

October 15, 2013

Sponsor

University Hospital, Tours

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

1. Study Identification

Unique Protocol Identification Number

NCT01061853

Brief Title

Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen

Acronym

RALIB

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2013

Overall Recruitment Status

Terminated

Why Stopped

Per protocol intermediate analyses of 76 patients and enrollment difficulties.

Study Start Date

February 2008 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Tours

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Lichen Planus

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE

Arm Title

Arm Type

Active Comparator

Arm Description

TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL

Intervention Type

Drug

Intervention Name(s)

TOPICAL SIROLIMUS (RAPAMUNE*)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

TOPICAL BETAMETHASONE 0.05%

Intervention Description

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

Primary Outcome Measure Information:

Title

COMPLETE CLEARING OF ORAL EROSIVE LESIONS

Time Frame

THREE MONTHS

Secondary Outcome Measure Information:

Title

REGRESSION OF EROSIVE SURFACE AREA

Time Frame

THREE MONTHS

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials: