Clinical trial NCT06988527: Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment
Official title: Treatment Outcomes and Patient Satisfaction of Oral Lichen Planus Treatment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Erosive Oral Lichen Planus
Atrophic Lichen Planus
Lead sponsor: Dar Al Uloom University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 56
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * 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 purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Assessment of OLP lesions using OLP score
timeFrame: baseline to 1 year
measure: Pain assessment using Visual analogue scale (VAS)
timeFrame: baseline- to 1 year
Secondary outcomes:
measure: Long-term satisfaction of patients with OLP treated with honey, recurrence rates, and quality of life after one year of treatment
timeFrame: baseline to 1 year
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Dar AlUloom University
Study officials:
affiliation: Dar AlUloom University, SA
name: Sally A ElHaddad, Assist. Prof
role: PRINCIPAL_INVESTIGATOR
References: