Lichen Planus, OralPhase 3NCT00130572
Efficacy of Elidel Cream on Erosive Oral Lichen Planus
A Phase 3 study testing Pimecrolimus in people with Lichen Planus, Oral, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The purpose of this study is to investigate whether topical applied pimecrolimus will lead to improvement of erosive oral lichen planus. This effect will be monitored by reduction of erosive mucosal area and reduction of patient's pain symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lichen Planus, Oral
- What is being tested?
- Pimecrolimus
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2004to Dec 2007
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically and histologically confirmed diagnosis of erosive oral lichen planus
- Spontaneous or meal related oral pain
- No topical therapy 2 weeks prior to study start
- No systemic therapy 4 weeks prior to study start
- Signed informed consent
Who cannot join
- Pregnant or breast-feeding women
- Known allergy to macrolide antibiotics
- Known current active malignant disease or in patient's history
- Known immunodeficiency or HIV infection
- Participation at another clinical trial within the last 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Placebo-Controlled Clinical Pilot Trial Regarding the Efficacy of Elidel Cream on Erosive Oral Lichen Planus
The purpose of this study is to investigate whether topical applied pimecrolimus will lead to improvement of erosive oral lichen planus. This effect will be monitored by reduction of erosive mucosal area and reduction of patient's pain symptoms.
Read the detailed description
Oral lichen planus is a mucosal inflammatory disease of unknown origin. It can be very painful especially if erosions appear on the oral mucosa.
In this study the efficacy of pimecrolimus compared to placebo in treatment of erosive oral lichen planus will be investigated. To this end the subjective pain and the amount of affected mucosa will be monitored before and after treatment.
- Conditions
- Lichen Planus, Oral
- Being tested
- Pimecrolimus
- 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.
PimecrolimusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment
Secondary outcomes (2)
Patient's and investigator's global assessment after 4 and 8 weeks
Pimecrolimus blood level after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2005 (estimated)
- Study startJun 2004
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen Planus, OralStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Investigators
- Tilo Biedermann, Prof. Dr. med., Principal investigator, University of Tuebingen, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130572
- Sponsor's protocol ID
- CASM981CDE12
- Status last verified
- May 2008
- First submitted
- 12 Aug 2005
- Last updated
- 23 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-Controlled Clinical Pilot Trial Regarding the Efficacy of Elidel Cream on Erosive Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT00130572
- Acronym / sponsor ID
- CASM981CDE12
- Conditions
- Lichen Planus, Oral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Aug 2005 (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 investigate whether topical applied pimecrolimus will lead to improvement of erosive oral lichen planus. This effect will be monitored by reduction of erosive mucosal area and reduction of patient's pain symptoms.
Detailed description
Oral lichen planus is a mucosal inflammatory disease of unknown origin. It can be very painful especially if erosions appear on the oral mucosa.
In this study the efficacy of pimecrolimus compared to placebo in treatment of erosive oral lichen planus will be investigated. To this end the subjective pain and the amount of affected mucosa will be monitored before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinically and histologically confirmed diagnosis of erosive oral lichen planus
- Spontaneous or meal related oral pain
- No topical therapy 2 weeks prior to study start
- No systemic therapy 4 weeks prior to study start
- Signed informed consent
Key exclusion criteria (5 listed)
- Pregnant or breast-feeding women
- Known allergy to macrolide antibiotics
- Known current active malignant disease or in patient's history
- Known immunodeficiency or HIV infection
- Participation at another clinical trial within the last 6 months
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 |
|---|---|---|
| Pimecrolimus | Drug | – |
Primary outcome
Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment
2 secondary outcomes
Patient's and investigator's global assessment after 4 and 8 weeks
Pimecrolimus blood level after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2008.
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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.
Tilo Biedermann, Prof. Dr. med. principal investigator
University of Tuebingen, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pimecrolimus in people with Lichen Planus, Oral, run by University Hospital Tuebingen at 1 site in Germany.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 23 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment. 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 23 May 2008.