CClinicalTrials.gg
Status unknownNCT04336488Updated Jun 19, 2020

Matrix Metalloproteinases Neutralizing Agents in Oral Lichen Planus

An Early Phase 1 interventional study of Matrix Metalloproteinase Inhibitors (Orochem) and Kenacort A, in Oral Lichen Planus, sponsored by Jaylane kadry Ghonima. Status unknown at 1 site in Egypt. Open to participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2020-06-19.

Sponsored by Jaylane kadry Ghonima · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2020), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2020, registered Apr 2020).
Phase
Early Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
25 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Oral Lichen Planus

Keywords

  • matrix metalloproteinase inhibitors, orochem, OLP
03

In context

Lichen Planus, Oral

139 studies on the registry are indexed under Lichen Planus, Oral; 24 are open to participants now.

This study's planned enrollment of 40 is above the median of 36 across 101 interventional studies indexed under Lichen Planus, Oral.

Browse Lichen Planus, Oral studies →

Lead sponsor

This is the only study on the registry with Jaylane kadry Ghonima as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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)

  • 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,

Interventions

  • DrugMatrix Metalloproteinase Inhibitors (Orochem)

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

  • DrugKenacort A,

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

    Also known as: miconaz gel

06

What researchers measure

Primary outcomes

  1. change in disease severity score

    Thongprasom disease severity score (5-0)

    Time frame: change in disease severity score from baseline to 3 weeks

07

Study locations

1 site
  • periodontology department, Faculty of dentistry, Alexandria University
    Alexandria, 21500, Egypt
08

References and documents

Individual participant data

Plan to share: No — participants data are not to be shared

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04336488
Lead sponsor
Jaylane kadry Ghonima
Responsible party
Jaylane kadry Ghonima (assistant lecturer, Alexandria University) — Sponsor-investigator
First posted
Apr 7, 2020
Start date
Jan 1, 2020
Primary completion
Jun 1, 2020
Completion
Jul 1, 2020 (estimated)
Last update
Jun 19, 2020

Study contacts

Hossam H. AlSabbagh, As. lecturer
principal investigator · Alexandria University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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