Matrix Metalloproteinases Neutralizing Agents in Oral Lichen Planus

NCT04336488 | Unknown Early Phase 1 DMC

• 1 other identifier: MMPs in lichen
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Oral Lichen Planus

Keywords

matrix metalloproteinase inhibitors, orochem, OLP

Outcome Measures

Primary Outcomes (1)

• change in disease severity score

  Thongprasom disease severity score (5-0)

  change in disease severity score from baseline to 3 weeks

Study Arms (2)

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.

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.

Drug: Kenacort A,

Interventions

Matrix Metalloproteinase Inhibitors (Orochem) DRUG

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

Orochem (Test)

Kenacort A, DRUG

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

Also known as: miconaz gel

Conventional (Control)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jaylane kadry Ghonima: lead

Study Sites (1)

periodontology department, Faculty of dentistry, Alexandria University

Alexandria, 21500, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Matrix Metalloproteinase Inhibitors; Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Hossam H. AlSabbagh, As. lecturer

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: participant, investigator as well as outcome assessor are blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer

Model Details: double equal arms

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: January 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: June 19, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)