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.

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Key information

Conditions

Lichen Planus, Oral Lichen Planus Lichenoid Eruptions Mouth Diseases Neoplasms Precancerous Conditions Preneoplastic Condition Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

25 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Messina

Messina, 98100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Healing evaluation

Drug

Treatments were topically applied for 5 days

Primary outcomes

Clinical Mucosal healing

Time frame: 180 days

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.

Sponsors and collaborators

Lead sponsor

University of Messina

Other

Registry information

Official study title

Analysis of the Efficacy of Two Treatment Protocols for Patients With Symptomatic Oral Lichen Planus

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Dec 17, 2020
Registry last updated: Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed