Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers (salivaLichen)

Pia Lopez Jornet

Status: Completed

Conditions: Oral Lichen Planus; Oral Lichen Planus Related Stress

Treatments: Drug: Hyaluronic acid 1%; Drug: Corticoid Acetonide triamcinolone 0.2%; Combination Product: Acetonide triamcinolone 0.2% +hyaluronicacid 1%

Study type: Interventional

Funder types: Other

Identifiers

NCT06332365

ID: 3938/2022

Details and patient eligibility

About

Lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. The treatment for oral lichen planus (OLP) includes a range of options, both topical and systemic therapies. Recent research has highlighted the potential of hyaluronic acid as a drug alternative, potentially offering effective management for OLP and alleviating the discomfort of this chronic condition. The objective was to assess the impact of topical hyaluronic acid on salivary oxidative stress markers in individuals suffering from oral lichen planus

Full description

Interventional (Clinical Trial) Actual Enrollment : 60 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Care Provider, Outcomes Assessor) Masking Description: The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used Primary Purpose: Treatment Pain , quality of life the study on oral lichen planus, three treatment groups were established:

Group I: Received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide.

Group II: Was treated solely with 0.2% triamcinolone acetonide. Group III: Received only 0.1% hyaluronic acid. These groups were designed to evaluate and compare the efficacy of different treatments in patients with oral lichen planus.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with diagnosis oral lichen planus. Patients with no history of taking corticosteroids for the last 6 months Patients who agrees to take medication.

Exclusion criteria

Pregnant and lactating ladies. Patients with recent dental filling associated with the lesion or associated with recent drug administration.

Patient with uncontrolled diabetes, uncontrolled hypertension,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Group I experimental

Experimental group

Description:

Group I: Received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide.

Treatment:

Combination Product: Acetonide triamcinolone 0.2% +hyaluronicacid 1%

Group II

Active Comparator group

Description:

Was treated exclusively with 0.2% triamcinolone acetonide.

Treatment:

Drug: Corticoid Acetonide triamcinolone 0.2%

Group III

Active Comparator group

Description:

Received only 0.1% hyaluronic acid.

Treatment:

Drug: Hyaluronic acid 1%