Matrix Metalloproteinases Neutralizing Agents in Oral Lichen Planus

June 18, 2020 updated by: Jaylane kadry Ghonima

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21500
        • Periodontology department, Faculty of Dentistry, Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Matrix Metalloproteinase Inhibitors (Orochem)
topical application of MMP inhibitors for 3 weeks to evaluate its effectiveness in treating oral lichen planus
ACTIVE_COMPARATOR: 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.
Drug: Kenacort A,
topical application of both drugs 3 times daily for 3 weeks as an active control
Other Names:
  • miconaz gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in disease severity score
Time Frame: change in disease severity score from baseline to 3 weeks
Thongprasom disease severity score (5-0)
change in disease severity score from baseline to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaylane kadry Ghonima

Investigators

  • Principal Investigator: Hossam H. AlSabbagh, As. lecturer, Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ACTUAL)

June 1, 2020

Study Completion (ANTICIPATED)

July 1, 2020

Study Registration Dates

First Submitted

April 3, 2020

First Submitted That Met QC Criteria

April 6, 2020

First Posted (ACTUAL)

April 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 19, 2020

Last Update Submitted That Met QC Criteria

June 18, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMPs in lichen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

participants data are not to be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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