NCT01061853

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_3

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

October 16, 2013

Status Verified

October 1, 2013

Enrollment Period

4.8 years

First QC Date

February 2, 2010

Last Update Submit

October 15, 2013

Conditions

Oral Lichen Planus

Keywords

Oral lichen planuschronic inflammatorymucous membraneserosive lesions

Outcome Measures

Primary Outcomes (1)

  • COMPLETE CLEARING OF ORAL EROSIVE LESIONS

    THREE MONTHS

Secondary Outcomes (1)

  • REGRESSION OF EROSIVE SURFACE AREA

    THREE MONTHS

Study Arms (2)

T

EXPERIMENTAL

TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE

Drug: TOPICAL SIROLIMUS (RAPAMUNE*)

C

ACTIVE COMPARATOR

TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL

Drug: TOPICAL BETAMETHASONE 0.05%

Interventions

TOPICAL SIROLIMUS (RAPAMUNE*)DRUG

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

T
TOPICAL BETAMETHASONE 0.05%DRUG

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

C

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Oral Lichen Planus
  • Oral Erosive Area More Than 1cm²
  • Lichen Planus Pathologically Proven

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University Hospital of REIMS

Reims, Marne, F-51092, France

Location

Hospital Avicenne-APHP

Bobigny, 93009, France

Location

University Hospital of Bordeaux-St.André

Bordeaux, 33075, France

Location

University Hospital of Lille

Lille, 59037, France

Location

University Hospital of Nice

Nice, 06202, France

Location

Hospital Saint Louis-APHP

Paris, 75475, France

Location

Hospital La Pitié-Salpêtrière APHP

Paris, 75651, France

Location

Hospital Tenon-APHP

Paris, 75970, France

Location

University hospital of Tours

Tours, 37044, France

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Loïc VAILLANT, MD

    Centre 1-TOURS

    STUDY DIRECTOR

  • Camille FRANCES, MD

    Centre-2 Tenon

    PRINCIPAL INVESTIGATOR

  • Scarlette AGBO-GODEAU, MD

    Centre-3 La Pitié-Salpêtrière

    PRINCIPAL INVESTIGATOR

  • Liliane LAROCHE, MD

    Centre-4 Avicenne

    PRINCIPAL INVESTIGATOR

  • Francis PASCAL, MD

    Centre-5 St-Louis

    PRINCIPAL INVESTIGATOR

  • Emmanuel DELAPORTE, MD

    Centre-6 Lille

    PRINCIPAL INVESTIGATOR

  • Alain TAÏEB, MD

    Centre-7 Bordeaux

    PRINCIPAL INVESTIGATOR

  • Jean-Philippe DELACOUR, MD

    Centre -8 Nice

    PRINCIPAL INVESTIGATOR

  • Philippe BERNARD, MD-PHD

    Centre-9 REIMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2010

First Posted

February 3, 2010

Study Start

February 1, 2008

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

October 16, 2013

Record last verified: 2013-10

Locations

FR(9)