Atrophic Oral Lichen PlanusPhase 1NCT01375101
Therapeutic Effect of Quercetin and the Current Treatment of Erosive and Atrophic Oral Lichen Planus
A Phase 1 study testing Quercetin in people with Atrophic Oral Lichen Planus and Erosive Oral Lichen Planus, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
Lichen planus (LP) is a common chronic inflammatory mucocutaneous disease with an immunologic etiology ,which has number of different clinical forms. Alternative natural or herbal origine drugs with antioxidant and anti-inflammatory properties have been used individually or in combination with systemic corticosteroids… Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Atrophic Oral Lichen Planus, Erosive Oral Lichen Planus
- What is being tested?
- Quercetin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Apr 2010to Sep 2011
- Phase
- Phase 1
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- confirmation of clinical diagnosis of Atrophic and erosive lichen planus by histological examination
- two weeks wash out periods after the last treatment
- having the experience of atrophic and erosive lesion greater than 1 cm having the experience of pain and burning greater than 3.5 in VAS Score
Who cannot join
- confirmation of dysplasia and malignancy in histologic examination
- confirmation of lichenoid reaction in histologic examination
- pregnancy and breast feeding
- using fluorokinolon and cyclosporin which interact with quercetin
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Mashhad university of Medical science, Research Center of oral and maxillofacial medicine
Mashhad, Razavi Khorasan Province, 91735
maryam amirchaghmaghi, assistant professor, 0098-0511882901, amirchakhmaghim@mums.ac.ir
About this study
Lichen planus (LP) is a common chronic inflammatory mucocutaneous disease with an immunologic etiology ,which has number of different clinical forms. Alternative natural or herbal origine drugs with antioxidant and anti-inflammatory properties have been used individually or in combination with systemic corticosteroids in order to decrease adverse drug reactions.
This study was conducted to evaluate the effect of quercetin on treatment of erosive -atrophic lesions of oral lichen planus (OLP).
- Being tested
- placebo, Quercetin
- Keywords
- lichen planus, quercetin
- Medical subject headings
- Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
The patient is directed to use placebo capsule two times a day, ,until the one mouth
QuercetinDrug
The patient is directed to digest quercetin hydrate capsule two times a day,until one mouth
| Study group | Role | What they receive |
|---|---|---|
| quercetin | Active comparator | quercetin is one of flavonoids , and having therapeutical anti-inflammatory and antioxidant action Receives: Drug: Quercetin |
| placebo | Placebo comparator | placebo capsul is produced with lactose for using in placebo/ control group. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the effects of this Drug on OLP measured with VAS scale for pain and evaluation of intensity of lesions.
In the present work the Analogical Visual Scale is used TO evaluate pain,and we also record the intensity of lesions weekly and any side effect of this Drug
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startApr 2010
- Primary completionSep 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01375101
- Sponsor's protocol ID
- 88705
- Status last verified
- Jul 2011
- First submitted
- 14 Jun 2011
- Last updated
- 26 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Quercetin and the Current Treatment of Erosive and Atrophic Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT01375101
- Acronym / sponsor ID
- 88705
- Keywords
- lichen planus, quercetin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 17 Jun 2011 (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.
Lichen planus (LP) is a common chronic inflammatory mucocutaneous disease with an immunologic etiology ,which has number of different clinical forms. Alternative natural or herbal origine drugs with antioxidant and anti-inflammatory properties have been used individually or in combination with systemic corticosteroids in order to decrease adverse drug reactions.
This study was conducted to evaluate the effect of quercetin on treatment of erosive -atrophic lesions 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
- 2
| Arm | Type | Receives |
|---|---|---|
| quercetin | Active comparator | Drug: Quercetinquercetin is one of flavonoids , and having therapeutical anti-inflammatory and antioxidant action |
| placebo | Placebo comparator | Drug: placeboplacebo capsul is produced with lactose for using in placebo/ control group. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- confirmation of clinical diagnosis of Atrophic and erosive lichen planus by histological examination
- two weeks wash out periods after the last treatment
- having the experience of atrophic and erosive lesion greater than 1 cm having the experience of pain and burning greater than 3.5 in VAS Score
Key exclusion criteria (4 listed)
- confirmation of dysplasia and malignancy in histologic examination
- confirmation of lichenoid reaction in histologic examination
- pregnancy and breast feeding
- using fluorokinolon and cyclosporin which interact with quercetin
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 |
|---|---|---|
| placeboThe patient is directed to use placebo capsule two times a day, ,until the one mouth | Drug | placebo |
| QuercetinThe patient is directed to digest quercetin hydrate capsule two times a day,until one mouth | Drug | quercetin |
Primary outcome
the effects of this Drug on OLP measured with VAS scale for pain and evaluation of intensity of lesions.
Time frame: 2 months
In the present work the Analogical Visual Scale is used TO evaluate pain,and we also record the intensity of lesions weekly and any side effect of this Drug
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Quercetin in people with Atrophic Oral Lichen Planus and Erosive 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 3 inclusion and 4 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 26 Jul 2011. 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. 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.
What does this 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.
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?
Contact maryam amirchaghmaghi, assistant professor (0098-0511889201, amirchakhmaghim@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the effects of this Drug on OLP measured with VAS scale for pain and evaluation of intensity of lesions. (time frame: 2 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 26 Jul 2011.