Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment

NCT06988527 | Recruiting Phase 2

• 1 other identifier: 010-012-2022
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Erosive Oral Lichen Planus; Atrophic Lichen Planus

Outcome Measures

Primary Outcomes (2)

• Clinical Assessment of OLP lesions using OLP score

  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.

  baseline to 1 year

• Pain assessment using Visual analogue scale (VAS)

  (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)

  baseline- to 1 year

Secondary Outcomes (1)

• 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

Study Arms (2)

Group I with OLP at buccal mucosa

EXPERIMENTAL

The trial Group (I) (honey in orabase 1: 1 paste), four times daily after meals or rinsing

Drug: Honey in orabase 1: 1 paste

Group II with OLP at buccal mucosa

ACTIVE COMPARATOR

Group (II): triamcinolone acetonide 0.1% ointment, four times daily after meals or rinsing

Drug: Honey in orabase 1: 1 paste

Interventions

Honey in orabase 1: 1 paste DRUG

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

Also known as: Triamcinolone acetonide 0.1% ointment

Group I with OLP at buccal mucosa; Group II with OLP at buccal mucosa

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dar Al Uloom University: lead

Study Sites (1)

Dar AlUloom University

Riyadh, 11512, Saudi Arabia

RECRUITING

MeSH Terms

Interventions

Honey; Triamcinolone Acetonide; Ointments

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Sally A ElHaddad, Assist. Prof

  Dar AlUloom University, SA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sally A ElHaddad, Assist Prof

CONTACT

00966011494; s.elhaddad@dau.edu.sa

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This was a double-blind, parallel-group clinical trial. Both participants and outcome assessors were blinded to the intervention. The honey in orabase and triamcinolone formulations were prepared to appear similar in color, texture, and packaging to ensure concealment. Identical containers were used for both treatments, and labeling was done using coded identifiers maintained by a third party not involved in the assessment or data analysis. Participants were instructed to apply the provided formulation as directed without being informed of the specific treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Oral Medicine and Periodontology

Model Details: * Zα/2=1.96=1.96 (for 95% confidence) * Zβ=1.28 (to 90% power) * SD=196 * Δ=1.33 N≈55.65 N=56 56 patients diagnosed with Oral Lichen Planus, randomly assigned to one of the 2 groups

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 17, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: IPD will be available beginning 6 months following publication and for up to 5 years. Data will be shared through secure data repositories or direct communication with the corresponding author, after review and approval of a formal data request, including a data use agreement.
• Access Criteria: Access to IPD will be granted to qualified researchers affiliated with academic institutions, healthcare organizations, or non-profit research entities. Requests must include: A research proposal with clear scientific objectives and methods Evidence of ethical approval (if applicable) A signed data use agreement ensuring confidentiality, data protection, and responsible data handling Agreement not to attempt to re-identify individual participants Requests will be evaluated by the study team based on scientific merit, ethical considerations, and alignment with the purpose of the original study.

Locations

SA (1)