RecruitingPhase 2Phase 3NCT06988527

Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment


Sponsor

Dar Al Uloom University

Enrollment

56 participants

Start Date

May 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to assess Honey in orabase (1:1) for treating patients with OLP and improving their quality of life: The research question aims to answer: Does honey in orabase (1:1) improve or reduce OLP symptoms compared to the standardized treatment by triamcinolone acetonide 0.1% drug and improve the patient's quality of life? Participants will: Take drug ABC or a placebo every day for 4 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms and the number of times they use a rescue inhaler


Eligibility

Min Age: 35 YearsMax Age: 60 Years

Inclusion Criteria3

  • Patients with a clinical diagnosis of oral lichen planus
  • Symptomatic OLP lesions (erosive/atrophic)
  • Participants are between 35 and 60 years old, who are able to adhere to the study protocol, and sign informed consent.

Exclusion Criteria5

  • Patients with other oral mucosal disorders, or systemic conditions influencing OLP or wound healing, allergies or hypersensitivity to honey or triamcinolone
  • Patients who administer systemic corticosteroids or immunosuppressive agents.
  • Pregnancy or lactation
  • Inability to comprehend or adhere to study directives
  • Patients who are not able to sign an informed written consent

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Interventions

DRUGHoney in orabase 1: 1 paste

The experimental drug was manufactured and packed at the Faculty of Pharmacy, Price Sattam University, SA. Production of a mucoadhesive paste involves a step-by-step process. in the final step, honey, comprising 50% of the total composition was thoroughly blended with the prepared base to ensure homogeneity


Locations(1)

Dar AlUloom University

Riyadh, Saudi Arabia

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NCT06988527