Erosive and Atrophic Oral Lichen PlanusPhase 1/2NCT01974414
Cedar Honey in Oral Lichen Planus
A Phase 1/2 study testing orally administered cedar honey in people with Erosive and Atrophic Oral Lichen Planus, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
The study aimed to evaluate the effect of cedar honey in treatment of erosive and atrophic oral lichen planus ( a common oral problem). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Erosive and Atrophic Oral Lichen Planus
- What is being tested?
- orally administered cedar honey
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteIran
- Study dates
- Sep 2011to Dec 2012
- Phase
- Phase 1/2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinically and histopathologically confirmed oral lichen planus without dysplasia in histopathologic evaluation
- Severity of pain≥2 (VAS score)
- Severity of lesions≥2 (tong prasom criteria)
- absence of any treatment in the last month
- absence of kidney or liver diseases( due to systemic administration of fluconazole to both groups)
Who cannot join
- evidence of lichenoid reaction in clinical or histopathologic assessment
- loss of follow up
- pregnant patients
- diabetic patients
- any other mucosal disease
- any severe systemic disease
- patients who refuse doctor's advice
- any unexpected adverse effect of honey
Trial locations and contacts
1 site in 1 country.
Iran1 site
Oral Medicine Department of Mashhad dental School,Oral and Maxillofacial diseases research center
Mashhad, Razavi Khorasan Province
About this study
Official title: Cedar Honey in Treatment of Oral Lichen Planus: a Randomized Clinical Trial
The study aimed to evaluate the effect of cedar honey in treatment of erosive and atrophic oral lichen planus ( a common oral problem).
- Conditions
- Erosive and Atrophic Oral Lichen Planus
- Being tested
- orally administered cedar honey
- Keywords
- oral lichen planus, cedar honey, atrophic, erosive, pain, treatment, clinical trial
- Medical subject headings
- Lichen Planus, Oral, Atrophy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orally administered cedar honeyDrug
| Study group | Role | What they receive |
|---|---|---|
| cedar honey | Active comparator | The two study groups were provided with standard treatment(dexamethasone and Fluconazole).The Case group(A) received cedar honey, 20 ml 3 times daily by swish and swallow technique, in addition to the standard treatment . Receives: Drug: orally administered cedar honey |
| control group | No intervention | the control group (B) only received standard treatment(Dexametazone and Fluconazole). |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity of lesions
severity of lesions due to thong prasom criteria
Measured: 4 weeks
Secondary outcomes (1)
size of lesions
A sterile caulis was used to measure the maximum diameter of erosive and atrophic lesions and the maximum width perpendicular to the maximum diameter was recorded.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive and Atrophic 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pegah Mosannen Mozafari, Mashhad University of Medical Sciences
- Investigators
- Majid Sanatkhani, Assistant Professor, Study director, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974414
- Sponsor's protocol ID
- 900166
- Status last verified
- Oct 2013
- First submitted
- 26 Oct 2013
- Last updated
- 1 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cedar Honey in Treatment of Oral Lichen Planus: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01974414
- Acronym / sponsor ID
- 900166
- Conditions
- Erosive and Atrophic Oral Lichen Planus
- Keywords
- oral lichen planus, cedar honey, atrophic, erosive, pain, treatment, clinical trial
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Nov 2013 (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 study aimed to evaluate the effect of cedar honey in treatment of erosive and atrophic oral lichen planus ( a common oral problem).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cedar honey | Active comparator | Drug: orally administered cedar honeyThe two study groups were provided with standard treatment(dexamethasone and Fluconazole).The Case group(A) received cedar honey, 20 ml 3 times daily by swish and swallow technique, in addition to the standard treatment . |
| control group | No intervention | –the control group (B) only received standard treatment(Dexametazone and Fluconazole). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- clinically and histopathologically confirmed oral lichen planus without dysplasia in histopathologic evaluation
- Severity of pain≥2 (VAS score)
- Severity of lesions≥2 (tong prasom criteria)
- absence of any treatment in the last month
- absence of kidney or liver diseases( due to systemic administration of fluconazole to both groups)
Key exclusion criteria (8 listed)
- evidence of lichenoid reaction in clinical or histopathologic assessment
- loss of follow up
- pregnant patients
- diabetic patients
- any other mucosal disease
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 |
|---|---|---|
| orally administered cedar honey | Drug | cedar honey |
Primary outcome
severity of lesions
Time frame: 4 weeks
severity of lesions due to thong prasom criteria
1 secondary outcome
size of lesions
Time frame: 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 1 Nov 2013.
Related trials for Erosive and Atrophic 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.
Majid Sanatkhani, Assistant Professor study director
Mashhad University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing orally administered cedar honey in people with Erosive and Atrophic 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 5 inclusion and 8 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 1 Nov 2013. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
severity of lesions (time frame: 4 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 1 Nov 2013.