Oral Lichen PlanusPhase 2NCT01524744
A Randomized Clinical Trial of the Effect of Pimecrolimus Cream 1% Compared With Topical Corticosteroid in Treatment of Erosive Oral Lichen Planus
A Phase 2 study testing Pimecrolimus ointment and Adcortyl in people with Oral Lichen Planus, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study is to compare the effect of topical Pimecrolimus with adcortyl on erosive-atrophic 0ral lichen planus in a randomized clinical trial study. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Pimecrolimus ointment and Adcortyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- Mar 2009to Dec 2012
- Phase
- Phase 2
- 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 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biopsy confirmed oral lichen planus in combination with a compatible clinical appearance was used for diagnosis.
Who cannot join
- Unable to undergo oral biopsy for diagnosis
- Systemic diseases or malignancy
- Pregnancy
- Lesion/lesions with dysplasia/ history of allergic reaction to corticosteroids or immunomodulatory drugs.
- Lesions adjacent to amalgam filling were also excluded from this study.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Mashhad University of Medical Science
Mashhad, Razavi Khorasan Province, 91735
About this study
The purpose of this study is to compare the effect of topical Pimecrolimus with adcortyl on erosive-atrophic 0ral lichen planus in a randomized clinical trial study.
- Conditions
- Oral Lichen Planus
- Being tested
- Pimecrolimus ointment, Adcortyl
- Keywords
- oral lichen planus treatment 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.
Pimecrolimus ointmentDrug
Case group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use
AdcortylDrug
triamcinolone acetonide 0.1% in orabase
| Study group | Role | What they receive |
|---|---|---|
| Pimecrolimus ointment 0.1 % | Active comparator | This group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use Receives: Drug: Pimecrolimus ointment; Drug: Adcortyl |
| Adcortyle | Active comparator | Control group used adcortyle (triamcinolone acetonide 0.1% in orabase, Bristol-Myers Squibbb, Anagn, Italy) Receives: Drug: Adcortyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
signs of oral lichen planus
size and type of oral lichen planus has been recorded
Measured: every 2 weeks
Secondary outcomes (1)
symptoms of oral lichen planus
pain of oral lesions has been recorded
Measured: every 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2012 (estimated)
- Study startMar 2009
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ATESSA PAKFETRAT, Mashhad University of Medical Sciences
- Investigators
- atessa pakfetrat, associate professor, Principal investigator, Mashhad University of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01524744
- Sponsor's protocol ID
- 87909
- Other IDs
- 87909
- Status last verified
- Jan 2012
- First submitted
- 31 Jan 2012
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of the Effect of Pimecrolimus Cream 1% Compared With Topical Corticosteroid in Treatment of Erosive Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT01524744
- Acronym / sponsor ID
- 87909
- Conditions
- Oral Lichen Planus
- Keywords
- oral lichen planus treatment pimecrolimus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 2 Feb 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 effect of topical Pimecrolimus with adcortyl on erosive-atrophic 0ral lichen planus in a randomized clinical trial study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pimecrolimus ointment 0.1 % | Active comparator | Drug: Pimecrolimus ointment, Drug: AdcortylThis group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use |
| Adcortyle | Active comparator | Drug: AdcortylControl group used adcortyle (triamcinolone acetonide 0.1% in orabase, Bristol-Myers Squibbb, Anagn, Italy) |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Biopsy confirmed oral lichen planus in combination with a compatible clinical appearance was used for diagnosis.
Key exclusion criteria (5 listed)
- Unable to undergo oral biopsy for diagnosis
- Systemic diseases or malignancy
- Pregnancy
- Lesion/lesions with dysplasia/ history of allergic reaction to corticosteroids or immunomodulatory drugs.
- Lesions adjacent to amalgam filling were also excluded from this study.
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 ointmentCase group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use | Drug | Pimecrolimus ointment 0.1 % |
| Adcortyltriamcinolone acetonide 0.1% in orabase | Drug | Adcortyle, Pimecrolimus ointment 0.1 % |
Primary outcome
signs of oral lichen planus
Time frame: every 2 weeks
size and type of oral lichen planus has been recorded
1 secondary outcome
symptoms of oral lichen planus
Time frame: every 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
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Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
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Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
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Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
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Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
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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.
atessa pakfetrat, associate professor principal investigator
Mashhad University of Medical Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pimecrolimus ointment and Adcortyl in people with Oral Lichen Planus, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Feb 2012. 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 Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
signs of oral lichen planus (time frame: every 2 weeks). 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 2 Feb 2012.