Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment

Phase 2

Recruiting

• Conditions: Erosive Oral Lichen Planus; Atrophic Lichen Planus

• Registration Number: NCT06988527
• Lead Sponsor: Dar Al Uloom University

Brief 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.

Study Timeline

• Study Start: 2024-08-20
• Status Verified: 2024-09
• Study First Submitted: 2025-05-16
• Study First Submitted QC: 2025-05-16
• Study First Posted: 2025-05-25
• Primary Completion: 2025-08-15
• Study Completion: 2025-09-01
• Last Update Submitted: 2025-09-26
• Last Update Posted: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical Assessment of OLP lesions using OLP score	baseline to 1 year	will be assessed by OLP score: Thongprasom et al.: score 0 (no lesions), score 1 (mild white striae only with no erythematous areas), score 2 (white striae exhibiting an atrophic area \< 1 cm2), score 3 (white striae alongside an atrophic area ≥ 1 cm2), score 4 (white striae in an erosive area \< 1 cm2), and score 5 (white striae alongside an erosive area ≥1 cm2). Atrophic OLP was defined as thinning of the oral mucosa, with a smooth red appearance, while erosive OLP involved ulceration and erosion of the mucosal surface.
Pain assessment using Visual analogue scale (VAS)	baseline- to 1 year	(VAS) is a self-reported score typically consisting of a 10 cm horizontal line from right (best) to left (worst) with verbal descriptions (word anchors: 0 cm: No pain; 1 cm: Hardly notice pain; 2 cm: Notice pain does not interfere with activities; 3 cm: Sometimes distracts me; 4 cm: Distracts me, can do usual activities; 5 cm: Interrupts some activities; 6 cm: Hard to ignore, avoid usual activities; 7 cm: focus of attention, prevent doing daily activities; 8 cm: Awful, hard to do anything; 9 cm: Can not bear the pain, unable to do anything; 10 cm: As bad as it could be, nothing else matters)

Secondary Outcome Measures

Name	Time	Method
Long-term satisfaction of patients with OLP treated with honey, recurrence rates, and quality of life after one year of treatment	baseline to 1 year	Patient Satisfaction: Measured using a Likert scale questionnaire (e.g., 1-5, where 1 = very dissatisfied and 5 = very satisfied).; Recurrence % or Complications; Quality of Life: Reassess by using OHIP-14 at each follow-up.

Trial Locations

Locations (1)

Dar AlUloom University; 🇸🇦 Riyadh, Saudi Arabia