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

March 25, 2024 updated by: Pia Lopez Jornet
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30004
        • Pia Lopez Jornet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I experimental
Group I: Received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide.
Combination product: Acetonide triamcinolone 0.2% +hyaluronicacid 1%
topical application cream form twice a day for 4 weeks
Other Names:
  • GroupI
Active Comparator: Group II
Was treated exclusively with 0.2% triamcinolone acetonide.
Drug: Corticoid Acetonide triamcinolone 0.2%
topical application cream form twice a day for 4 weeks
Other Names:
  • GropupII
Active Comparator: Group III
Received only 0.1% hyaluronic acid.
Drug: Hyaluronic acid 1%
topical application cream form twice a day for 4 weeks
Other Names:
  • groupIII

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment scale
Time Frame: 4 weeks
visual analog scale (VAS) score 0-10 higher scores mean a worse outcome.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks
OHIP-14 questionnaire
Time Frame: 4 weeks
evaluate the oral health related quality of life score 0-56 higher scores mean a worse outcome
4 weeks
Salivary level of oxidative stress biomarker
Time Frame: 4 weeks
Salivary level of oxidative stress biomarker Amilase; Glutation, IgA, FRAP, ADA
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pia Lopez Jornet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2022

Primary Completion (Actual)

December 15, 2023

Study Completion (Actual)

February 19, 2024

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

March 27, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID: 3938/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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