Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-20

Study Completion Date

2025-09-30

Brief Summary

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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

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Detailed Description

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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

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Erosive Oral Lichen Planus Atrophic Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* 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

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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Group I with OLP at buccal mucosa

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

Group Type EXPERIMENTAL

Honey in orabase 1: 1 paste

Intervention Type 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

Group II with OLP at buccal mucosa

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

Group Type ACTIVE_COMPARATOR

Honey in orabase 1: 1 paste

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Triamcinolone acetonide 0.1% ointment

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No