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Impact of Curcumin Application on Lichen Planus Oral lesions

Impact of Topical Application of nanoparticulate Curcumin in the treatment of Oral Lichen Planus lesions

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
REBEC
Registry ID
RBR-2bpfjs
Enrollment
Unknown
Registered
2020-05-28
Start date
2018-06-02
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lichen planus

Interventions

Experimental group: 7 patients with oral lichen planus lesions diagnosed clinically and histopathologically applied topically 3x / day nanoparticulate curcumin over the lesions for a period of 30 days
Drug
J01.637.512.600
V03.175.250

Sponsors

Faculdade de Odontologia de Araraquara - UNESP
Lead Sponsor
Coordenação de Aperfeiçoamento Pesoal de Nível Superior
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Clinical and histopathological diagnosis of OLP, based on World Health Organization criteria modified by van Der Meij et al.. These criteria take into account the association between clinical criteria (presence of bilateral lesions, more or less symmetrical; appearance of grayish and white line-shaped plaques with reticular characteristic; erosive, atrophic, bullous and plaque lesions associated with reticular lesions in any location of the oral mucosa); and histopathological criteria (presence of a well-defined zone of cellular infiltrate in the form of a band, with increased number of intra-epithelial lymphocytes as well as signs of degeneration in the basal cell layer and absence of epithelial dysplasia; keratinocyte apoptosis in the intra-epithelial region. Associated with the clinical-histopathological diagnosis of OLP, patients should be over 18 years old and have painful symptoms.

Exclusion criteria

Exclusion criteria: Use of medications that can induce lichenoid reactions (antihypertensive drugs, anticonvulsants, non-steroidal anti-inflammatory drugs, antibiotics and diuretics); histological signs of dysplasia; pregnant or lactating patients; presence of orthodontic appliances; lesions close to amalgam restorations and medical contraindication to the use of fluconazole.

Design outcomes

Primary

MeasureTime frame
Reduction of symptoms and signs of oral lichen planus using the Visual Analogue Scale and Thongprasom Classification, respectively, assessed weekly during active treatment (30 days) and 30, 60 and 90 days after the end of treatment.

Secondary

MeasureTime frame
Modulation of the expression of the transcription factor NF-B and the amount of T cells present by immunohistochemical analysis comparing the biopsy performed at the end of treatment with the initial biopsy.

Countries

Brazil

Contacts

Public ContactMariely Godoi

Universidade Estadual Paulista Júlio de Mesquita Filho

marielygodoi@gmail.com+55-016-33016300

Outcome results

None listed

Source: REBEC (via WHO ICTRP)