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Treatment Protocols for Patients With Symptomatic Oral Lichen Planus

NCT ID: NCT04673916

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-06-25

Brief Summary

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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

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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.

Conditions

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Lichen Planus, Oral Preneoplastic Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 groups of patients
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Healing evaluation

Intervention Type DRUG

Treatments were topically applied for 5 days

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.

Group Type ACTIVE_COMPARATOR

Healing evaluation

Intervention Type DRUG

Treatments were topically applied for 5 days

Interventions

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Healing evaluation

Treatments were topically applied for 5 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Messina

OTHER

Sponsor Role lead

Responsible Party

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Gaetano Isola, DDS, PhD

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Messina

Messina, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 33374791 (View on PubMed)

Other Identifiers

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121/120/PO

Identifier Type: -

Identifier Source: org_study_id