Matrix Metalloproteinases Neutralizing Agents in Oral Lichen Planus

NCT ID: NCT04336488

Last Updated: 2020-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-07-01

Brief Summary

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The current study will be conducted to evaluate the effectiveness of matrix metalloproteinases inhibitors on erosive oral lichen planus.

Detailed Description

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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

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

double equal arms
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
participant, investigator as well as outcome assessor are blinded

Study Groups

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Orochem (Test)

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.

Group Type EXPERIMENTAL

Matrix Metalloproteinase Inhibitors (Orochem)

Intervention Type DRUG

topical application of MMP inhibitors for 3 weeks to evaluate its effectiveness in treating oral lichen planus

Conventional (Control)

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.

Group Type ACTIVE_COMPARATOR

Kenacort A,

Intervention Type DRUG

topical application of both drugs 3 times daily for 3 weeks as an active control

Interventions

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Matrix Metalloproteinase Inhibitors (Orochem)

topical application of MMP inhibitors for 3 weeks to evaluate its effectiveness in treating oral lichen planus

Intervention Type DRUG

Kenacort A,

topical application of both drugs 3 times daily for 3 weeks as an active control

Intervention Type DRUG

Other Intervention Names

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miconaz gel

Eligibility Criteria

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Inclusion Criteria

* patients diagnosed with erosive OLP confirmed with a biopsy.
* patients should have symptomatic lesions

Exclusion Criteria

* Patients who were under anticoagulant medications, suffering from any systemic diseases or having any physical or mental abnormality, pregnant and lactating women, smokers.
Minimum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jaylane kadry Ghonima

OTHER

Sponsor Role lead

Responsible Party

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Jaylane kadry Ghonima

assistant lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hossam H. AlSabbagh, As. lecturer

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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periodontology department, Faculty of dentistry, Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MMPs in lichen

Identifier Type: -

Identifier Source: org_study_id

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