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OpenTrials
Completed

NCT Number: NCT06332365

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

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

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Key information

Conditions

Oral Lichen Planus Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Oral Lichen Planus Related Stress Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pia Lopez Jornet

Murcia, 30004, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Acetonide triamcinolone 0.2% +hyaluronicacid 1%

Combination Product

topical application cream form twice a day for 4 weeks

Other names: GroupI

Corticoid Acetonide triamcinolone 0.2%

Drug

topical application cream form twice a day for 4 weeks

Other names: GropupII

Hyaluronic acid 1%

Drug

topical application cream form twice a day for 4 weeks

Other names: groupIII

Primary outcomes

  1. Pain assessment scale

    Time frame: 4 weeks

    visual analog scale (VAS) score 0-10 higher scores mean a worse outcome.

Secondary outcomes

  1. OHIP-14 questionnaire

    Time frame: 4 weeks

    evaluate the oral health related quality of life score 0-56 higher scores mean a worse outcome

  2. reduction of clinical signs measure

    Time frame: 4 weeks

    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

  3. Salivary level of oxidative stress biomarker

    Time frame: 4 weeks

    Salivary level of oxidative stress biomarker Amilase; Glutation, IgA, FRAP, ADA

Sponsors and collaborators

Lead sponsor

Pia Lopez Jornet

Other

Registry information

Acronym: salivaLichen

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Mar 27, 2024
Registry last updated
Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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