Status:
COMPLETED
Effect of Bifidobacterium Animalis Subsp. Lactis HN019 on Oral Lichen Planus
Lead Sponsor:
University of Sao Paulo
Conditions:
Oral Lichen Planus
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Lichen planus is a chronic inflammatory mucocutaneous disease, which often results in oral manifestations, receiving the name of oral lichen planus (OLP). Its frequency varies from 0,1 to 4% of the ge...
Detailed Description
This is a randomized double-blind clinical trial with symptomatic patients presenting OLP, which will be randomly assigned to either topical Bifidobacterium animalis subsp lactis HN019 or clobetasol p...
Eligibility Criteria
Inclusion
- Clinical inclusion
- Adults ≥ 18 years old, both genres, who consent to participate of the study;
- Presence of symptomatic reticular lesion and/or white-gray papules. In afro-descendent individuals, reticular lesions may be associated with hyperpigmented lesions;
- Additional clinical features such as ulcerative, erythematous, plaque and bullous lesions will be accepted in the presence of bilateral and symmetrical reticular lesions.
- Histopathological inclusion criteria
- Presence of subepithelial infiltrate predominantly lymphocytic, in band and confined to the subepithelial area.
- Liquefaction degeneration of the basal cells layer.
Exclusion
- Clinical exclusion criteria
- Exclusion of contact lichenoid lesions: the pattern of reticular lesion and / or papules should not be present only in areas of physical contact with restorative materials;
- Exclusion of lichenoid reaction to the drug: difficult to differentiate from OLP, however it is necessary to report all drugs in use by the patient; the comparison between patients on medication, and those who do not use medication is important to establish subgroups of OLP;
- Exclusion of chronic graft versus host disease (GVHD): differentiation between OLP and GVHD is established in most cases by medical history;
- Exclusion of immunocompromised patients or patients with systemic diseases of high complexity.
- Exclusion of patients who have previously used probiotic bacteria in the last 4 weeks prior to the study.
- Histopathological criteria for exclusion • Presence of epithelial dysplasia, absence of the lymphocytic inflammatory infiltrate band and liquefaction degeneration.
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2019
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03386643
Start Date
November 6 2017
End Date
December 6 2019
Last Update
March 27 2020
Active Locations (1)
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1
School of Dentistry of Ribeirão Preto, University of São Paulo
Ribeirão Preto, São Paulo, Brazil, 14040-904