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

NCT ID: NCT06332365

Last Updated: 2024-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-03

Study Completion Date

2024-02-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Oral Lichen Planus Oral Lichen Planus Related Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Randomization: The enrolled subjects were randomly assigned to one of two treatment protocols using a computer-generated table. This method ensures impartial allocation and avoids biases in treatment selection for each patient.

Masking: Medications were prepared and packaged in identical, sealed, and numbered envelopes by the hospital pharmacy and a clinician not involved in the subsequent phases of the study. Each sealed envelope contained the protocol assignment for individual patients and written instructions for the application of the medications. Moreover, clinicians involved in treatment evaluation at each follow-up session were blinded to the treatment assigned to each patient.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group I experimental

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

Group Type EXPERIMENTAL

Acetonide triamcinolone 0.2% +hyaluronicacid 1%

Intervention Type COMBINATION_PRODUCT

topical application cream form twice a day for 4 weeks

Group II

Was treated exclusively with 0.2% triamcinolone acetonide.

Group Type ACTIVE_COMPARATOR

Corticoid Acetonide triamcinolone 0.2%

Intervention Type DRUG

topical application cream form twice a day for 4 weeks

Group III

Received only 0.1% hyaluronic acid.

Group Type ACTIVE_COMPARATOR

Hyaluronic acid 1%

Intervention Type DRUG

topical application cream form twice a day for 4 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acetonide triamcinolone 0.2% +hyaluronicacid 1%

topical application cream form twice a day for 4 weeks

Intervention Type COMBINATION_PRODUCT

Corticoid Acetonide triamcinolone 0.2%

topical application cream form twice a day for 4 weeks

Intervention Type DRUG

Hyaluronic acid 1%

topical application cream form twice a day for 4 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

GroupI GropupII groupIII

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pia Lopez Jornet

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Pia Lopez Jornet

Head Oral Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pia Lopez Jornet

Murcia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 37713153 (View on PubMed)

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.

Reference Type RESULT
PMID: 37109100 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ID: 3938/2022

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Management of Pain in Oral Lichen Planus
NCT03572959 COMPLETED PHASE4
Evaluating LP-10 in Subjects With OLP
NCT06233591 ACTIVE_NOT_RECRUITING PHASE2