NCT06988527

Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Dar Al Uloom University · Academic / Other
• Sex: All
• Age: 35 Years – 60 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study comprised 56 patients diagnosed with Oral Lichen Planus, who were randomly selected according to inclusion and exclusion criteria. The subjects were between 35 and 60 years old, capable of complying with the study procedure, and provided informed consent. Exclusion criteria encompassed those with alternative oral mucosal illnesses, systemic problems influencing OLP or wound healing, allergies or sensitivities to honey or triamcinolone, or those receiving systemic corticosteroids or immunosuppressive drugs. Individuals who were pregnant or lactating, as well as those unable to provide informed written consent, were excluded.

Conditions

• Erosive Oral Lichen Planus
• Atrophic Lichen Planus

Interventions

Type	Name	Description
DRUG	Honey 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

Timeline

• Start date: 2025-05-20
• Primary completion: 2026-06-15
• Completion: 2026-06-30
• First posted: 2025-05-25
• Last updated: 2026-02-17

Locations

1 site across 1 country: Saudi Arabia