Status:
COMPLETED
Study on Treatment for Patients With Symptomatic Oral Lichen Planus
Lead Sponsor:
University of Catania
Conditions:
Lichen Planus, Oral
Eligibility:
All Genders
25-70 years
Phase:
NA
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 sy...
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 oligomeri...
Eligibility Criteria
Inclusion
- age ≥ 18 years;
- clinical diagnosis and histological diagnosis of OLP on the basis of WHO criteria;
- presence of symptoms related to OLP.
Exclusion
- 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.
Key Trial Info
Start Date :
January 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04718311
Start Date
January 2 2019
End Date
March 20 2020
Last Update
January 22 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Catania
Catania, CT, Italy, 95124