MedDataX Logo

Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen

NCT ID: NCT01061853

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Lichen Planus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Oral lichen planus chronic inflammatory mucous membranes erosive lesions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

T

TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE

Group Type EXPERIMENTAL

TOPICAL SIROLIMUS (RAPAMUNE*)

Intervention Type DRUG

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

C

TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL

Group Type ACTIVE_COMPARATOR

TOPICAL BETAMETHASONE 0.05%

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TOPICAL SIROLIMUS (RAPAMUNE*)

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

Intervention Type DRUG

TOPICAL BETAMETHASONE 0.05%

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER_GOV

Sponsor Role collaborator

University Hospital, Tours

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Loïc VAILLANT, MD

Role: STUDY_DIRECTOR

Centre 1-TOURS

Camille FRANCES, MD

Role: PRINCIPAL_INVESTIGATOR

Centre-2 Tenon

Scarlette AGBO-GODEAU, MD

Role: PRINCIPAL_INVESTIGATOR

Centre-3 La Pitié-Salpêtrière

Liliane LAROCHE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre-4 Avicenne

Francis PASCAL, MD

Role: PRINCIPAL_INVESTIGATOR

Centre-5 St-Louis

Emmanuel DELAPORTE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre-6 Lille

Alain TAÏEB, MD

Role: PRINCIPAL_INVESTIGATOR

Centre-7 Bordeaux

Jean-Philippe DELACOUR, MD

Role: PRINCIPAL_INVESTIGATOR

Centre -8 Nice

Philippe BERNARD, MD-PHD

Role: PRINCIPAL_INVESTIGATOR

Centre-9 REIMS

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital of REIMS

Reims, Marne, France

Site Status

Hospital Avicenne-APHP

Bobigny, , France

Site Status

University Hospital of Bordeaux-St.André

Bordeaux, , France

Site Status

University Hospital of Lille

Lille, , France

Site Status

University Hospital of Nice

Nice, , France

Site Status

Hospital Saint Louis-APHP

Paris, , France

Site Status

Hospital La Pitié-Salpêtrière APHP

Paris, , France

Site Status

Hospital Tenon-APHP

Paris, , France

Site Status

University hospital of Tours

Tours, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007-000152-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PHRN06-LV/RALIB

Identifier Type: -

Identifier Source: org_study_id