Clinical trial NCT06332365: Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers
Official title: Evaluating Treatment Efficacy in Oral Lichen Planus: The Role of Salivary Biomarkers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Lichen Planus
Oral Lichen Planus Related Stress
Keywords: treatment
saliva stress
oral lichen planus
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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,

Primary outcomes:
measure: Pain assessment scale
timeFrame: 4 weeks
Secondary outcomes:
measure: OHIP-14 questionnaire
timeFrame: 4 weeks
measure: reduction of clinical signs measure
timeFrame: 4 weeks
measure: Salivary level of oxidative stress biomarker
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Pia Lopez Jornet
Study officials:
References:
citation: Louisy A, Humbert E, Samimi M. Oral Lichen Planus: An Update on Diagnosis and Management. Am J Clin Dermatol. 2024 Jan;25(1):35-53. doi: 10.1007/s40257-023-00814-3. Epub 2023 Sep 15.
citation: Leong XY, Gopinath D, Syeed SM, Veettil SK, Shetty NY, Menon RK. Comparative Efficacy and Safety of Interventions for the Treatment of Oral Lichen Planus: A Systematic Review and Network Meta-Analysis. J Clin Med. 2023 Apr 7;12(8):2763. doi: 10.3390/jcm12082763.