NCT06332365

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 3, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 19, 2024

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2024

Completed
Last Updated

March 27, 2024

Status Verified

February 1, 2024

Enrollment Period

1.9 years

First QC Date

March 19, 2024

Last Update Submit

March 25, 2024

Conditions

Oral Lichen PlanusOral Lichen Planus Related Stress

Keywords

treatmentsaliva stressoral lichen planus

Outcome Measures

Primary Outcomes (1)

  • Pain assessment scale

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

    4 weeks

Secondary Outcomes (3)

  • OHIP-14 questionnaire

    4 weeks

  • reduction of clinical signs measure

    4 weeks

  • Salivary level of oxidative stress biomarker

    4 weeks

Study Arms (3)

Group I experimental

EXPERIMENTAL

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

Combination Product: Acetonide triamcinolone 0.2% +hyaluronicacid 1%

Group II

ACTIVE COMPARATOR

Was treated exclusively with 0.2% triamcinolone acetonide.

Drug: Corticoid Acetonide triamcinolone 0.2%

Group III

ACTIVE COMPARATOR

Received only 0.1% hyaluronic acid.

Drug: Hyaluronic acid 1%

Interventions

Acetonide triamcinolone 0.2% +hyaluronicacid 1%COMBINATION_PRODUCT

topical application cream form twice a day for 4 weeks

Also known as: GroupI
Group I experimental
Corticoid Acetonide triamcinolone 0.2%DRUG

topical application cream form twice a day for 4 weeks

Also known as: GropupII
Group II
Hyaluronic acid 1%DRUG

topical application cream form twice a day for 4 weeks

Also known as: groupIII
Group III

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with diagnosis oral lichen planus. Patients with no history of taking corticosteroids for the last 6 months Patients who agrees to take medication.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pia Lopez Jornet

Murcia, 30004, Spain

Location

Related Publications (2)

  • 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.

    PMID: 37713153RESULT

  • 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.

    PMID: 37109100RESULT

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Triamcinolonelyve1b protein, zebrafish

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichen PlanusLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head Oral Medicine

Study Record Dates

First Submitted

March 19, 2024

First Posted

March 27, 2024

Study Start

January 3, 2022

Primary Completion

December 15, 2023

Study Completion

February 19, 2024

Last Updated

March 27, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)