Rebamipide (Regular & Nanoparticulated) vs. Clobetasol in Management of Methotrexate-Induced Oral Ulceration in Rheumatoid Arthritis Patients

• Status: Not yet recruiting
• Trial end date: 2021-11-30
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this intervention study is to compare the effect of topical Rebamipide (regular and nanoparticulated) to topical Clobetasol propionate in management of Methotrexate induced oral mucositis in patients with rheumatoid arthritis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cairo University
• Treatments: Clobetasol; Rebamipide

Criteria

Inclusion Criteria:

• Patient who agreed to sign the informed consent.

• Age: 20-70 years old.

• Gender: males and females

• RA patients treated with MTX and suffering from MTX-induced oral ulceration.

Exclusion Criteria:

• Patients refused to sign the informed consent.

• Pregnant or lactating females in their child bearing age group.

• patients with known or suspected history of hypersensitivity to any of the ingredients of the preparation of the drugs used.

• Systemic disease: such as uncontrolled diabetes mellitus, auto-immune diseases known to cause oral ulceration, renal or liver dysfunction or any other condition considered risky by the clinician.

• Patients treated with any medication for the condition at the time of setting.

• Salivary gland diseases.

• Malignancy.