Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Honey in orabase 1: 1 paste.
- Who it may be relevant to
- Registry conditions: Erosive Oral Lichen Planus, Atrophic Lichen Planus. Basic parameters: 35 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- Clinical Assessment of OLP lesions using OLP score [Time frame: baseline to 1 year]
- Pain assessment using Visual analogue scale (VAS) [Time frame: baseline- to 1 year]
Secondary outcome measures (1)
- Long-term satisfaction of patients with OLP treated with honey, recurrence rates, and quality of life after one year of treatment [Time frame: baseline to 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Saudi Arabia · 1 center
- Dar AlUloom University — Riyadh
Identifiers
NCT: NCT06988527 · 010-012-2022