Oral Lichen PlanusNCT01544842
Tacrolimus Ointment in Oral Lichen Planus
A study testing 0.1 % tacrolimus ointment, 0.1 % triamcinolone paste and Orabase paste in people with Oral Lichen Planus, run by University of Oulu at 2 sites in Finland.
Trial summary
The purpose of this study is to compare the effectiveness of topical tacrolimus, triamcinolone and placebo in alleviating signs and symptoms of oral lichen planus (OLP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- 0.1 % tacrolimus ointment, 0.1 % triamcinolone paste and Orabase paste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesFinland
- Study dates
- Aug 2004to Jul 2015
- Phase
- Interventional
- 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
- Diagnosis of OLP made by a specialist in oral pathology based on clinical and histopathological features
- Clinical score for OLP ≥ 20 at baseline
- Symptomatic OLP at baseline
- Washout period of 2 weeks
- Age over 18
Who cannot join
- Pregnant or lactating women
- Allergy to tacrolimus or other macrolides
- Allergy to other drugs or substances used in the study
- Abnormal liver function
- Netherton's syndrome
- Cyclosporin medication
- Other regular medication that could have significant interactions with tacrolimus
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Oral and Maxillofacial Diseases Clinic, Kuopio University Hospital
Kuopio, 70029
Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu
Oulu, 90014
About this study
Official title: Comparison of Topical Tacrolimus, Triamcinolone and Placebo in the Treatment of Symptomatic Oral Lichen Planus
The purpose of this study is to compare the effectiveness of topical tacrolimus, triamcinolone and placebo in alleviating signs and symptoms of oral lichen planus (OLP).
- Conditions
- Oral Lichen Planus
- Being tested
- 0.1 % tacrolimus ointment, 0.1 % triamcinolone paste, Orabase paste
- Keywords
- Oral lichen planus, Tacrolimus ointment, Triamcinolone paste
- 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.
0.1 % tacrolimus ointmentDrug
Also called Protopic
applied topically to oral mucosa
0.1 % triamcinolone pasteDrug
Also called Kenacort-T paste, Kenacort-A paste
applied topically to oral mucosa
Orabase pasteDrug
applied topically to oral mucosa
| Study group | Role | What they receive |
|---|---|---|
| Tacrolimus | Active comparator | Tacrolimus ointment 0.1%, three times a day for 6-9 weeks. Receives: Drug: 0.1 % tacrolimus ointment |
| Triamcinolone | Active comparator | Triamcinolone paste 0.1%, three times a day for 3-6 weeks. Receives: Drug: 0.1 % triamcinolone paste |
| Placebo | Placebo comparator | Orabase paste, three times a day for 3-6 weeks. Receives: Drug: Orabase paste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical score for OLP
The clinical score for OLP is a measure designed by the investigators for assessing the clinical extent and type of OLP, and the symptoms experienced by the patient. The value of the score is between 0-120.
Measured: 1,2,3,4,5,6,7,8 and 9 weeks, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startAug 2004
- Primary completionFeb 2015
- Study completionJul 2015
Why it stopped: Lack of resources
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio University Hospital
- Responsible party
- Sponsor
- Investigators
- Tuula Salo, DDS, PhD, Principal investigator, Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu, Oulu, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544842
- Sponsor's protocol ID
- Takrolimuusi123
- Status last verified
- Dec 2014
- First submitted
- 4 Jan 2012
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical Tacrolimus, Triamcinolone and Placebo in the Treatment of Symptomatic Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT01544842
- Acronym / sponsor ID
- Takrolimuusi123
- Conditions
- Oral Lichen Planus
- Keywords
- Oral lichen planus, Tacrolimus ointment, Triamcinolone paste
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of resources
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Kuopio University Hospital
- Study start
- Aug 2004
- Primary completion
- Feb 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 6 Mar 2012 (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 compare the effectiveness of topical tacrolimus, triamcinolone and placebo in alleviating signs and symptoms of oral lichen planus (OLP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus | Active comparator | Drug: 0.1 % tacrolimus ointmentTacrolimus ointment 0.1%, three times a day for 6-9 weeks. |
| Triamcinolone | Active comparator | Drug: 0.1 % triamcinolone pasteTriamcinolone paste 0.1%, three times a day for 3-6 weeks. |
| Placebo | Placebo comparator | Drug: Orabase pasteOrabase paste, three times a day for 3-6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of OLP made by a specialist in oral pathology based on clinical and histopathological features
- Clinical score for OLP ≥ 20 at baseline
- Symptomatic OLP at baseline
- Washout period of 2 weeks
- Age over 18
Key exclusion criteria (7 listed)
- Pregnant or lactating women
- Allergy to tacrolimus or other macrolides
- Allergy to other drugs or substances used in the study
- Abnormal liver function
- Netherton's syndrome
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 |
|---|---|---|
| 0.1 % tacrolimus ointmentAlso: Protopicapplied topically to oral mucosa | Drug | Tacrolimus |
| 0.1 % triamcinolone pasteAlso: Kenacort-T paste, Kenacort-A pasteapplied topically to oral mucosa | Drug | Triamcinolone |
| Orabase pasteapplied topically to oral mucosa | Drug | Placebo |
Primary outcome
Change in clinical score for OLP
Time frame: 1,2,3,4,5,6,7,8 and 9 weeks, 6 months
The clinical score for OLP is a measure designed by the investigators for assessing the clinical extent and type of OLP, and the symptoms experienced by the patient. The value of the score is between 0-120.
Results and safety
The study was stopped early (reason given: Lack of resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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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.
Tuula Salo, DDS, PhD principal investigator
Department of Diagnostics and Oral Medicine, Institute of Dentistry, University of Oulu, Oulu, Finland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.1 % tacrolimus ointment, 0.1 % triamcinolone paste and Orabase paste in people with Oral Lichen Planus, run by University of Oulu at 2 sites in Finland.
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 7 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 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of resources). 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?
Change in clinical score for OLP (time frame: 1,2,3,4,5,6,7,8 and 9 weeks, 6 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 17 Jul 2015.