Oral Lichen PlanusNCT03871114
Evaluation of Salivary Level of miR-155 and IL-10 in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid
An observational study of Oral Lichen Planus, run by Cairo University at 1 site in Egypt.
Trial summary
Thirty patients will be recruited from the outpatient clinic of the faculty of dentistry.fifteen systemically healthy individuals with normal mucosa and fifteen atrophic/erosive oral lichen planus patients. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Triamcinolone Acetonide in orabase
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2019to 25 Apr 2019
- Phase
- Observational
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with atrophic/erosive oral lichen planus
Who may be able to join
- Patients clinically and histopathologically diagnosed as having atrophic/erosive OLP.
- Patients free from any other oral lesions
- cooperative patients who agrees to take the supplied medications.
- Patients who are systemically healthy
Who cannot join
- Patients suffering from any systemic disease.
- Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
- Treatment with any oral topical medications for at least four weeks prior to the study.
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Salivary Levels of miR-155 and IL-10 in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid
Thirty patients will be recruited from the outpatient clinic of the faculty of dentistry.fifteen systemically healthy individuals with normal mucosa and fifteen atrophic/erosive oral lichen planus patients. Oral lichen planus patients will be treated with a topical steroid and miR-155 and IL-10 will be assessed in saliva before and after 4 weeks of topical steroids use
- Conditions
- Oral Lichen Planus
- Being tested
- Triamcinolone Acetonide in orabase
- 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.
Triamcinolone Acetonide in orabaseDrug
Also called topical corticosteroid
treatment of OLP with topical steroid
| Study group | Role | What they receive |
|---|---|---|
| OLP patients | fifteen patients with atrophic /erosive OLP will receive treatment with topical triamcinolone acetonide in orabase 1mg/g 3 times /day and assessed every week for 4 weeks Receives: Drug: Triamcinolone Acetonide in orabase | |
| Control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of salivary levels of miR-155 in OLP before treatment
assessment of miR-155 in saliva of patients with OLP before treatment
Measured: baseline
Measurement of salivary levels of IL-10 in OLP before treatment
assessment of IL-10 in saliva of patients with OLP before treatment
Measured: baseline
Secondary outcomes (2)
Measurement of salivary levels of miR-155 in OLP after treatment
assessment of miR-155 in saliva of patients with OLP after treatment
Measured: 4 weeks
Measurement of salivary levels of IL-10 in OLP after treatment
assessment of IL-10 in saliva of patients with OLP after treatment
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 posted12 Mar 2019
- Study start10 Mar 2019
- Primary completion10 Apr 2019
- Study completion25 Apr 2019
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.
- More trials run by Cairo UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Mohamed Amr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871114
- Sponsor's protocol ID
- miR-155 OLP
- Status last verified
- Jul 2019
- First submitted
- 9 Mar 2019
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Salivary Levels of miR-155 and IL-10 in Oral Lichen Planus Patients Before and After Treatment With Topical Corticosteroid
- ClinicalTrials.gov ID
- NCT03871114
- Acronym / sponsor ID
- miR-155 OLP
- Conditions
- Oral Lichen Planus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Mar 2019 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 25 Apr 2019 (actual)
- First posted
- 12 Mar 2019 (actual)
- 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.
Thirty patients will be recruited from the outpatient clinic of the faculty of dentistry.fifteen systemically healthy individuals with normal mucosa and fifteen atrophic/erosive oral lichen planus patients. Oral lichen planus patients will be treated with a topical steroid and miR-155 and IL-10 will be assessed in saliva before and after 4 weeks of topical steroids use
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OLP patients | – | Drug: Triamcinolone Acetonide in orabasefifteen patients with atrophic /erosive OLP will receive treatment with topical triamcinolone acetonide in orabase 1mg/g 3 times /day and assessed every week for 4 weeks |
| Control group | – | – |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with atrophic/erosive oral lichen planus
Key inclusion criteria (4 listed)
- Patients clinically and histopathologically diagnosed as having atrophic/erosive OLP.
- Patients free from any other oral lesions
- cooperative patients who agrees to take the supplied medications.
- Patients who are systemically healthy
Key exclusion criteria (4 listed)
- Patients suffering from any systemic disease.
- Treatment with any systemic treatment such as systemic steroids, other immunosuppressive drugs or non-steroidal anti-inflammatory drugs at least eight weeks.
- Treatment with any oral topical medications for at least four weeks prior to the study.
- Pregnant and lactating women.
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 |
|---|---|---|
| Triamcinolone Acetonide in orabaseAlso: topical corticosteroidtreatment of OLP with topical steroid | Drug | OLP patients |
Primary outcome
Measurement of salivary levels of miR-155 in OLP before treatment
Time frame: baseline
assessment of miR-155 in saliva of patients with OLP before treatment
Measurement of salivary levels of IL-10 in OLP before treatment
Time frame: baseline
assessment of IL-10 in saliva of patients with OLP before treatment
2 secondary outcomes
Measurement of salivary levels of miR-155 in OLP after treatment
Time frame: 4 weeks
Measurement of salivary levels of IL-10 in OLP after treatment
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 26 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Lichen Planus, run by Cairo University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 26 Jul 2019. 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 Egypt. 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.
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?
Measurement of salivary levels of miR-155 in OLP before treatment (time frame: baseline). The study lists 2 primary outcomes in all. 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 2019.