NCT04718311

Brief Summary

The primary objective of this study was to compare the therapeutic efficacy of Tacrolimus gel versus an anti-inflammatory mouthwash in an oral solution for the management of patients suffering from symptomatic OLP. The secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects.

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 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.2 years

First QC Date

January 16, 2021

Last Update Submit

January 20, 2021

Conditions

Lichen Planus, Oral

Outcome Measures

Primary Outcomes (1)

  • Clinical Mucosal healing

    Patients clinically were evaluated using the scale used by Thongprasom et al. as reference. This gives a score that varies from 0 to 5, using a millimetre reference: 0, in the absence of lesions; 1, in the presence of hyperkeratosis streaks; 2, in the presence of an atrophic area less than 1 mm2; 3, in the presence of an atrophic area greater than 1 mm2; 4, in the presence of an erosive area less than 1 mm2; 5, in the presence of an erosive area greater than 1 mm2. In the presence of multiple injuries, the value has been calculated by summing the values of each injury.

    180 days

Study Arms (2)

Tacrolimus treatment

ACTIVE COMPARATOR

Apply a small amount (about 1 teaspoon) of medication to the lesions, twice a day after brushing the teeth, with a soft bristle toothbrush or with a finger (covered with a well-fitting glove).

Drug: Oral lichen clinical Healing evaluation

Anti-inflammatory mouthwash

PLACEBO COMPARATOR

Anti-inflammatory mouthwash In patients of the anti-inflammatory group, the mouthwash was used pure and without dilution at a dosage of 20 ml 3 times a day, immediately after normal daily oral hygiene was prescribed. It contains calcium hydroxide, hyaluronic acid, Umbelliferone and Oligomeric Proanthocyanidins. Patients were instructed to rinse for at least 5 minutes over the entire oral mucosa, with particular emphasis on the regions where the lesions are located.

Drug: Oral lichen clinical Healing evaluation

Interventions

Oral lichen clinical Healing evaluationDRUG

Treatments were topically applied for 5 days

Also known as: Topical drug tacrolimus or mouthwash application
Anti-inflammatory mouthwashTacrolimus treatment

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥ 18 years;
  • clinical diagnosis and histological diagnosis of OLP on the basis of WHO criteria;
  • presence of symptoms related to OLP.

You may not qualify if:

  • presence of systemic conditions that may have affected the study results;
  • state of pregnancy or breastfeeding;
  • histological signs of dysplasia;
  • drugs inducing a lichen response (ACE-inhibitors, β-blockers, etc.);
  • treatment of OLP in the six months prior to the start of the programme;
  • presence of extraoral lesions (genital, skin and other)
  • history of previous immunodeficiency or HIV seropositivity;
  • previous allogeneic bone marrow transplantation;
  • presence of systemic lupus erythematosus or other autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Catania

Catania, CT, 95124, Italy

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Condition Hierarchy (Ancestors)

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

Study Officials

  • Gaetano Isola

    Università degli Studi di Catania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

January 16, 2021

First Posted

January 22, 2021

Study Start

January 2, 2019

Primary Completion

March 5, 2020

Study Completion

March 20, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

Sharing results

Shared Documents
STUDY PROTOCOL
Time Frame
1 year
Access Criteria
pubmed

Locations

IT(1)