Clinical trial NCT01061853: Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen
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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Oral Lichen Planus
Keywords: Oral lichen planus
chronic inflammatory
mucous membranes
erosive lesions
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2010-02-03
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: COMPLETE CLEARING OF ORAL EROSIVE LESIONS
timeFrame: THREE MONTHS
Secondary outcomes:
measure: REGRESSION OF EROSIVE SURFACE AREA
timeFrame: THREE MONTHS
Other outcomes:
Locations:
city: Reims
country: France
facility: University Hospital of REIMS
state: Marne
city: Bobigny
country: France
facility: Hospital Avicenne-APHP
city: Bordeaux
country: France
facility: University Hospital of Bordeaux-St.André
city: Lille
country: France
facility: University Hospital of Lille
city: Nice
country: France
facility: University Hospital of Nice
city: Paris
country: France
facility: Hospital Saint Louis-APHP
city: Paris
country: France
facility: Hospital La Pitié-Salpêtrière APHP
city: Paris
country: France
facility: Hospital Tenon-APHP
city: Tours
country: France
facility: University hospital of Tours
Study officials:
affiliation: Centre 1-TOURS
name: Loïc VAILLANT, MD
role: STUDY_DIRECTOR
affiliation: Centre-2 Tenon
name: Camille FRANCES, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre-3 La Pitié-Salpêtrière
name: Scarlette AGBO-GODEAU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre-4 Avicenne
name: Liliane LAROCHE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre-5 St-Louis
name: Francis PASCAL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre-6 Lille
name: Emmanuel DELAPORTE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre-7 Bordeaux
name: Alain TAÏEB, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre -8 Nice
name: Jean-Philippe DELACOUR, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre-9 REIMS
name: Philippe BERNARD, MD-PHD
role: PRINCIPAL_INVESTIGATOR
References: