- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04673916
Treatment Protocols for Patients With Symptomatic Oral Lichen Planus
December 11, 2020 updated by: Gaetano Isola, DDS, PhD, University of Messina
Analysis of the Efficacy of Two Treatment Protocols for Patients With Symptomatic Oral Lichen Planus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Messina, Italy, 98100
- University of Messina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Clobetasol treatment
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.
|
Treatments were topically applied for 5 days
|
Active 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.
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Treatments were topically applied for 5 days
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Mucosal healing
Time Frame: 180 days
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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.
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180 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2019
Primary Completion (Actual)
February 15, 2020
Study Completion (Actual)
June 25, 2020
Study Registration Dates
First Submitted
December 10, 2020
First Submitted That Met QC Criteria
December 11, 2020
First Posted (Actual)
December 17, 2020
Study Record Updates
Last Update Posted (Actual)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 11, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 121/120/PO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Sharing clinical results
IPD Sharing Time Frame
1 year
IPD Sharing Access Criteria
University website and pubmed
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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