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

Oral Lichen Planus Clinical Trial

— salivaLichen  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06332365
• Other study ID #: ID: 3938/2022
• Status: Completed
• Phase: N/A
• Start date: January 3, 2022
• Est. completion date: February 19, 2024

Study information

• Verified date: February 2024
• Source: Universidad de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 19, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus
• Oral Lichen Planus Related Stress

Intervention

Combination Product:
• Acetonide triamcinolone 0.2% +hyaluronicacid 1%
topical application cream form twice a day for 4 weeks

Drug:
• Corticoid Acetonide triamcinolone 0.2%
topical application cream form twice a day for 4 weeks
• Hyaluronic acid 1%
topical application cream form twice a day for 4 weeks

Locations

Country	Name	City	State
Spain	Pia Lopez Jornet	Murcia

Sponsors (1)

Lead Sponsor	Collaborator
Pia Lopez Jornet

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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/jcm12 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment scale	visual analog scale (VAS) score 0-10 higher scores mean a worse outcome.	4 weeks
Secondary	OHIP-14 questionnaire	evaluate the oral health related quality of life score 0-56 higher scores mean a worse outcome	4 weeks
Secondary	reduction of clinical signs measure	Thongprasom Score 5 = white striae with erosive area = 1 cm2 Score 4 = white striae with erosive area < 1 cm2 Score 3 = white striae with erosive area > 1 cm2 Score 2 = white striae with atrophic area < 1 cm2 Score 1 = mild white striae only Score 0 = no lesion normal	4 weeks
Secondary	Salivary level of oxidative stress biomarker	Salivary level of oxidative stress biomarker Amilase; Glutation, IgA, FRAP, ADA	4 weeks