Matrix Metalloproteinases Neutralizing Agents in Oral Lichen Planus

Early Phase 1

• Conditions: Oral Lichen Planus
• Interventions: Drug: Kenacort A,; Drug: Matrix Metalloproteinase Inhibitors (Orochem)

• Registration Number: NCT04336488
• Lead Sponsor: Jaylane kadry Ghonima

Brief Summary

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 Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-06
• Study First Posted: 2020-04-07
• Status Verified: 2020-06
• Primary Completion: 2020-06-01
• Last Update Submitted: 2020-06-18
• Last Update Posted: 2020-06-19
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional (Control)	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.
Orochem (Test)	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.

Primary Outcome Measures

Name	Time	Method
change in disease severity score	change in disease severity score from baseline to 3 weeks	Thongprasom disease severity score (5-0)

Trial Locations

Locations (1)

periodontology department, Faculty of dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt