Matrix Metalloproteinases Neutralizing Agents in Oral Lichen Planus

Overview

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

Full Title of Study: “Effectiveness of Matrix Metalloproteinase Neutralizing Agent in Treatment of Oral Lichen Planus: A Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 1, 2020

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.

Interventions

  • Drug: Matrix Metalloproteinase Inhibitors (Orochem)
    • topical application of MMP inhibitors for 3 weeks to evaluate its effectiveness in treating oral lichen planus
  • Drug: Kenacort A,
    • topical application of both drugs 3 times daily for 3 weeks as an active control

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 25 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jaylane kadry Ghonima
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Jaylane kadry Ghonima, assistant lecturer – Alexandria University
  • Overall Official(s)
    • Hossam H. AlSabbagh, As. lecturer, Principal Investigator, Alexandria University

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