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Treatment Of Oral Lichen Planus

NCT06327620 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-03-25

No results posted yet for this study

Summary

This novel project aims to explore an alternative treatment for oral lichen planus (OLP), a challenging condition with limited therapeutic options. The proposed treatment involves the topical application of Daivobet ointment, a combination of calcipotriol (vitamin D analog) and betamethasone (corticosteroid), which has shown promising results in the treatment of psoriasis Vulgaris.

The study will involve 15 patients aged 30-60 years with clinically confirmed intra-oral erosive lichen planus, some of whom have not responded to current therapies. Participants will apply Daivobet ointment three times daily for four weeks, with clinical assessments conducted at the beginning, and at the end of the second and fourth weeks.

Inclusion criteria require the presence of bilateral oral erosive lichen planus lesions, with clinical and histopathological confirmation based on the World Health Organization's modified definition. Exclusion criteria include histological signs of dysplasia, use of drugs possibly causing lichenoid reactions, recent treatment for OLP, and hypersensitivity to the study drug.

Clinical evaluations will employ a scoring system based on lesion characteristics, including ulceration, erythema, and reticulation, measured with a calibrated grid. Subjective responses will be assessed through discomfort scores on a visual analog scale, and a questionnaire will capture any adverse effects. Digital photographs will document visual changes, and incisional biopsies will be performed to confirm the diagnosis.

The project aims to provide valuable insights into the efficacy and safety of the Daivobet ointment as a potential alternative treatment for oral lichen planus, offering hope for improved outcomes for patients suffering from this challenging condition.

Conditions

  • Lichen Planus

Interventions

COMBINATION_PRODUCT

Daivobet ointment, topical steroids

Daivobet Ointment: This intervention involves the topical application of Daivobet ointment, which is a combination of calcipotriol and betamethasone. The application is to be done three times daily for four weeks. Topical Steroid: This intervention entails the topical application of a steroid ointment three times daily for four weeks. The specific steroid and its details are not disclosed in the provided information.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-15
Primary Completion
2024-05-20
Completion
2024-05-20

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06327620 on ClinicalTrials.gov