Back to resultsTreatment Protocols for Patients With Symptomatic Oral Lichen Planus
Primary Purpose
Lichen Planus, Oral, Preneoplastic Condition
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
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 Messina
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Clobetasol treatment
Anti-inflammatory mouthwash
Arm Description
The clobetasol group was treated with clobetasol propionate 0.05%, while the anti-inflammatory group was treated with mouthwash. The drug used consisted of Clobetasol propionate 0.05%, Ethyl alcohol 96° (50%), Hydroxyethylcellulose (4%); Preserved water (just enough to 100%) that was topically applied [11]. This drug was produced as a galenic formulation. Clobetasol propionate twice a day (every 12 hours) to the lesions with a soft bristle brush and were advised not to drink or eat during the hour following application of the medication.
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
NCT04673916
First Posted
December 10, 2020
Last Updated
December 11, 2020
Sponsor
University of Messina
1. Study Identification
Unique Protocol Identification Number
NCT04673916
Brief Title
Treatment Protocols for Patients With Symptomatic Oral Lichen Planus
Official Title
Analysis of the Efficacy of Two Treatment Protocols for Patients With Symptomatic Oral Lichen Planus
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
June 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Messina
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 clobetasol propionate 0.05% oral 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
Forty patients were assigned (20 patients per group), through a randomized design, to receive clobetasol (clobetasol gel 0.05%), 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, Preneoplastic Condition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups of patients
Masking
Participant
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clobetasol treatment
Arm Type
Active Comparator
Arm Description
The clobetasol group was treated with clobetasol propionate 0.05%, while the anti-inflammatory group was treated with mouthwash. The drug used consisted of Clobetasol propionate 0.05%, Ethyl alcohol 96° (50%), Hydroxyethylcellulose (4%); Preserved water (just enough to 100%) that was topically applied [11]. This drug was produced as a galenic formulation. Clobetasol propionate twice a day (every 12 hours) to the lesions with a soft bristle brush and were advised not to drink or eat during the hour following application of the medication.
Arm Title
Anti-inflammatory mouthwash
Arm Type
Active Comparator
Arm Description
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)
Healing evaluation
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.
Facility Information:
Facility Name
University of Messina
City
Messina
ZIP/Postal Code
98100
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Sharing clinical results
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
University website and pubmed
Citations:
PubMed Identifier
33374791
Citation
Santonocito S, Polizzi A, De Pasquale R, Ronsivalle V, Lo Giudice A, Isola G. Analysis of the Efficacy of Two Treatment Protocols for Patients with Symptomatic Oral Lichen Planus: A Randomized Clinical Trial. Int J Environ Res Public Health. 2020 Dec 23;18(1):56. doi: 10.3390/ijerph18010056.
Results Reference
derived
Learn more about this trial
Treatment Protocols for Patients With Symptomatic Oral Lichen Planus
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