Oral Lichen PlanusPhase 3RALIBNCT01061853
Efficacy of Topical Rapamycin to Treat Chronic Erosive Oral Lichen
A Phase 3 study testing TOPICAL SIROLIMUS (RAPAMUNE*) and TOPICAL BETAMETHASONE 0.05% in people with Oral Lichen Planus, run by University Hospital, Tours at 9 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- TOPICAL SIROLIMUS (RAPAMUNE*) and TOPICAL BETAMETHASONE 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 9 sitesFrance
- Study dates
- Feb 2008to Nov 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Oral Lichen Planus
- Oral Erosive Area More Than 1cm²
- Lichen Planus Pathologically Proven
Who cannot join
- 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
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- Leucopenia (<3000/Mm3)
- Thrombopenia (<100 000/Mm3)
- Hypertransaminasemia (>3n)
- Hypersensitivity To Macrolides
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Hospital Avicenne-APHP
Bobigny, 93009
University Hospital of Bordeaux-St.André
Bordeaux, 33075
University Hospital of Lille
Lille, 59037
University Hospital of Nice
Nice, 06202
Hospital Saint Louis-APHP
Paris, 75475
Hospital La Pitié-Salpêtrière APHP
Paris, 75651
Hospital Tenon-APHP
Paris, 75970
University Hospital of REIMS
Reims, Marne, F-51092
University hospital of Tours
Tours, 37044
About this study
Official title: Efficacy of Topical Rapamycin in Treatment of Chronic Erosive Oral Lichen Planus. Double Blind Randomised Controlled Trial Rapamycin vs Topical Steroids
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.
- Conditions
- Oral Lichen Planus
- Being tested
- TOPICAL SIROLIMUS (RAPAMUNE*), TOPICAL BETAMETHASONE 0.05%
- Keywords
- Oral lichen planus, chronic inflammatory, mucous membranes, erosive lesions
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOPICAL SIROLIMUS (RAPAMUNE*)Drug
APPLICATION ON THE LESIONS OF TOPICAL SIROLIMUS (RAPAMUNE*)1mg/ml bid during 3 months
TOPICAL BETAMETHASONE 0.05%Drug
APPLICATION ON THE LESIONS OF TOPICAL BETAMETHASONE (DIPROLENE*)0.05% bid during 3 months
| Study group | Role | What they receive |
|---|---|---|
| T | Experimental | TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE Receives: Drug: TOPICAL SIROLIMUS (RAPAMUNE*) |
| C | Active comparator | TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL Receives: Drug: TOPICAL BETAMETHASONE 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMPLETE CLEARING OF ORAL EROSIVE LESIONS
Measured: THREE MONTHS
Secondary outcomes (1)
REGRESSION OF EROSIVE SURFACE AREA
Measured: THREE MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startFeb 2008
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Per protocol intermediate analyses of 76 patients and enrollment difficulties.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Lichen PlanusStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Loïc VAILLANT, MD, Study director, Centre 1-TOURSCamille FRANCES, MD, Principal investigator, Centre-2 TenonScarlette AGBO-GODEAU, MD, Principal investigator, Centre-3 La Pitié-SalpêtrièreLiliane LAROCHE, MD, Principal investigator, Centre-4 AvicenneFrancis PASCAL, MD, Principal investigator, Centre-5 St-LouisEmmanuel DELAPORTE, MD, Principal investigator, Centre-6 LilleAlain TAÏEB, MD, Principal investigator, Centre-7 BordeauxJean-Philippe DELACOUR, MD, Principal investigator, Centre -8 Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061853
- Sponsor's protocol ID
- PHRN06-LV/RALIB
- Other IDs
- 2007-000152-14
- Acronym
- RALIB
- Status last verified
- Oct 2013
- First submitted
- 2 Feb 2010
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Rapamycin in Treatment of Chronic Erosive Oral Lichen Planus. Double Blind Randomised Controlled Trial Rapamycin vs Topical Steroids
- ClinicalTrials.gov ID
- NCT01061853
- Acronym / sponsor ID
- RALIB / PHRN06-LV/RALIB
- Conditions
- Oral Lichen Planus
- Keywords
- Oral lichen planus, chronic inflammatory, mucous membranes, erosive lesions
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per protocol intermediate analyses of 76 patients and enrollment difficulties.
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Feb 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 3 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T | Experimental | Drug: TOPICAL SIROLIMUS (RAPAMUNE*)TOPICAL SIROLIMUS AND PETROLATUM IN ORABASE |
| C | Active comparator | Drug: TOPICAL BETAMETHASONE 0.05%TOPICAL BETAMETHASONE 0.05% in ORABASE AND PHOSAL |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Oral Lichen Planus
- Oral Erosive Area More Than 1cm²
- Lichen Planus Pathologically Proven
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TOPICAL SIROLIMUS (RAPAMUNE*)APPLICATION ON THE LESIONS OF TOPICAL SIROLIMUS (RAPAMUNE*)1mg/ml bid during 3 months | Drug | T |
| TOPICAL BETAMETHASONE 0.05%APPLICATION ON THE LESIONS OF TOPICAL BETAMETHASONE (DIPROLENE*)0.05% bid during 3 months | Drug | C |
Primary outcome
COMPLETE CLEARING OF ORAL EROSIVE LESIONS
Time frame: THREE MONTHS
1 secondary outcome
REGRESSION OF EROSIVE SURFACE AREA
Time frame: THREE MONTHS
Results and safety
The study was stopped early (reason given: Per protocol intermediate analyses of 76 patients and enrollment difficulties.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loïc VAILLANT, MD study director
Centre 1-TOURS
Camille FRANCES, MD principal investigator
Centre-2 Tenon
Scarlette AGBO-GODEAU, MD principal investigator
Centre-3 La Pitié-Salpêtrière
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TOPICAL SIROLIMUS (RAPAMUNE*) and TOPICAL BETAMETHASONE 0.05% in people with Oral Lichen Planus, run by University Hospital, Tours at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Per protocol intermediate analyses of 76 patients and enrollment difficulties.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMPLETE CLEARING OF ORAL EROSIVE LESIONS (time frame: THREE MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2013.