Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment

Dar Al Uloom University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Atrophic Lichen Planus; Erosive Oral Lichen Planus

Treatments: Drug: Honey in orabase 1: 1 paste

Study type: Interventional

Funder types: Other

Identifiers

NCT06988527

010-012-2022

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 estimated patients

Sex: All

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

Group I with OLP at buccal mucosa

Experimental group

Description:

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

Treatment:

Drug: Honey in orabase 1: 1 paste

Group II with OLP at buccal mucosa

Active Comparator group

Description:

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

Treatment:

Drug: Honey in orabase 1: 1 paste