Back to resultsStudy on Treatment for Patients With Symptomatic Oral Lichen Planus
Primary Purpose
Lichen Planus, Oral
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Oral lichen clinical Healing evaluation
Sponsored by
About this trial
This is an interventional treatment trial for Lichen Planus, Oral
Eligibility Criteria
Inclusion Criteria:
- age ≥ 18 years;
- clinical diagnosis and histological diagnosis of OLP on the basis of WHO criteria;
- presence of symptoms related to OLP.
Exclusion Criteria:
- 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.
Sites / Locations
- University of Catania
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Tacrolimus treatment
Anti-inflammatory mouthwash
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04718311
First Posted
January 16, 2021
Last Updated
January 20, 2021
Sponsor
University of Catania
1. Study Identification
Unique Protocol Identification Number
NCT04718311
Brief Title
Study on Treatment for Patients With Symptomatic Oral Lichen Planus
Official Title
Analysis of Two Treatment Protocols for Patients With Oral Lichen Planus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
March 5, 2020 (Actual)
Study Completion Date
March 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Catania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Thirty nine patients were assigned, through a randomized design, to receive tacrolimus ointment 0.1% or a mouthwash composed of calcium hydroxide 10%, hyaluronic acid 0,3%, umbelliferone and oligomeric proanthocyanidins, or an anti-inflammatory mouthwash (mouthwash which contains calcium hydroxide, hyaluronic acid, Umbelliferone and Oligomeric Proanthocyanidins) for 3-months. At baseline (T0) and after 3 months (T1), patients were subjected to clinical and oral assessments and were evaluated for the symptoms (Numerical Pain Scale, NRS score) and signs (Thongprasom's score) of OLP. Data were calculated using T-test for the dependent variable, Wilcoxon test and Mann-Witney u test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Planus, Oral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tacrolimus treatment
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Anti-inflammatory mouthwash
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral lichen clinical Healing evaluation
Other Intervention Name(s)
Topical drug tacrolimus or mouthwash application
Intervention Description
Treatments were topically applied for 5 days
Primary Outcome Measure Information:
Title
Clinical Mucosal healing
Description
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.
Time Frame
180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age ≥ 18 years;
clinical diagnosis and histological diagnosis of OLP on the basis of WHO criteria;
presence of symptoms related to OLP.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano Isola
Organizational Affiliation
Università degli Studi di Catania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Catania
City
Catania
State/Province
CT
ZIP/Postal Code
95124
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Sharing results
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
pubmed
Learn more about this trial
Study on Treatment for Patients With Symptomatic Oral Lichen Planus
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