Oral Lichen PlanusEarly Phase 1NCT04336488
Matrix Metalloproteinases Neutralizing Agents in Oral Lichen Planus
A Early Phase 1 study testing Matrix Metalloproteinase Inhibitors (Orochem) and Kenacort A, in people with Oral Lichen Planus, run by Jaylane kadry Ghonima at 1 site in Egypt.
Trial summary
The current study will be conducted to evaluate the effectiveness of matrix metalloproteinases inhibitors on erosive oral lichen planus. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- Matrix Metalloproteinase Inhibitors (Orochem) and Kenacort A,
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 1 Jul 2020
- Phase
- Early 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with erosive OLP confirmed with a biopsy.
- patients should have symptomatic lesions
Who cannot join
- Patients who were under anticoagulant medications, suffering from any systemic diseases or having any physical or mental abnormality, pregnant and lactating women, smokers.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
periodontology department, Faculty of dentistry, Alexandria University
Alexandria, 21500
About this study
Official title: Effectiveness of Matrix Metalloproteinase Neutralizing Agent in Treatment of Oral Lichen Planus: A Pilot Study
The current study will be conducted to evaluate the effectiveness of matrix metalloproteinases inhibitors on erosive oral lichen planus.
Read the detailed description
Matrix metalloproteinases inhibitor (Orochem) will be given to patients with Oral erosive lichen planus three times daily for 3 weeks. Then the subjective discomfort and pain severity as well as the objective disease severity scores will be collected.
- Conditions
- Oral Lichen Planus
- Being tested
- Matrix Metalloproteinase Inhibitors (Orochem), Kenacort A,
- Keywords
- matrix metalloproteinase inhibitors, orochem, OLP
- 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.
Matrix Metalloproteinase Inhibitors (Orochem)Drug
topical application of MMP inhibitors for 3 weeks to evaluate its effectiveness in treating oral lichen planus
Kenacort A,Drug
Also called miconaz gel
topical application of both drugs 3 times daily for 3 weeks as an active control
| Study group | Role | What they receive |
|---|---|---|
| Orochem (Test) | Experimental | fifteen patients with lichen planus will be treated with MMPs neutralizing agent 3 times daily for 3 weeks. then pain, discomfort and disease severity will be assessed at 1 and 3 weeks periods. Receives: Drug: Matrix Metalloproteinase Inhibitors (Orochem) |
| Conventional (Control) | Active comparator | fifteen patients with oral lichen planus confirmed with a biopsy will be treated with topical corticosteroids, topical antifungal 3 timed daily for 3 weeks. then pain, discomfort and disease severity will be assessed at 1 and 3 weeks periods. Receives: Drug: Kenacort A, |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in disease severity score
Thongprasom disease severity score (5-0)
Measured: change in disease severity score from baseline to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Jan 2020
- Primary completion1 Jun 2020
- Study completion1 Jul 2020 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double equal arms
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaylane kadry Ghonima
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jaylane kadry Ghonima, Alexandria University
- Investigators
- Hossam H. AlSabbagh, As. lecturer, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336488
- Sponsor's protocol ID
- MMPs in lichen
- Status last verified
- Jun 2020
- First submitted
- 3 Apr 2020
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: participants data are not to be shared
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Matrix Metalloproteinase Neutralizing Agent in Treatment of Oral Lichen Planus: A Pilot Study
- ClinicalTrials.gov ID
- NCT04336488
- Acronym / sponsor ID
- MMPs in lichen
- Conditions
- Oral Lichen Planus
- Keywords
- matrix metalloproteinase inhibitors, orochem, OLP
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jaylane kadry GhonimaUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 7 Apr 2020 (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.
The current study will be conducted to evaluate the effectiveness of matrix metalloproteinases inhibitors on erosive oral lichen planus.
Detailed description
Matrix metalloproteinases inhibitor (Orochem) will be given to patients with Oral erosive lichen planus three times daily for 3 weeks. Then the subjective discomfort and pain severity as well as the objective disease severity scores will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double equal arms
| Arm | Type | Receives |
|---|---|---|
| Orochem (Test) | Experimental | Drug: Matrix Metalloproteinase Inhibitors (Orochem)fifteen patients with lichen planus will be treated with MMPs neutralizing agent 3 times daily for 3 weeks. then pain, discomfort and disease severity will be assessed at 1 and 3 weeks periods. |
| Conventional (Control) | Active comparator | Drug: Kenacort A,fifteen patients with oral lichen planus confirmed with a biopsy will be treated with topical corticosteroids, topical antifungal 3 timed daily for 3 weeks. then pain, discomfort and disease severity will be assessed at 1 and 3 weeks periods. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients diagnosed with erosive OLP confirmed with a biopsy.
- patients should have symptomatic lesions
Key exclusion criteria (1 listed)
- Patients who were under anticoagulant medications, suffering from any systemic diseases or having any physical or mental abnormality, pregnant and lactating women, smokers.
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 |
|---|---|---|
| Matrix Metalloproteinase Inhibitors (Orochem)topical application of MMP inhibitors for 3 weeks to evaluate its effectiveness in treating oral lichen planus | Drug | Orochem (Test) |
| Kenacort A,Also: miconaz geltopical application of both drugs 3 times daily for 3 weeks as an active control | Drug | Conventional (Control) |
Primary outcome
change in disease severity score
Time frame: change in disease severity score from baseline to 3 weeks
Thongprasom disease severity score (5-0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Individual participant dataSharing planned: No. participants data are not to be shared
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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.
Hossam H. AlSabbagh, As. lecturer principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Matrix Metalloproteinase Inhibitors (Orochem) and Kenacort A, in people with Oral Lichen Planus, run by Jaylane kadry Ghonima 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 2 inclusion and 1 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 19 Jun 2020. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
change in disease severity score (time frame: change in disease severity score from baseline to 3 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 19 Jun 2020.