Treatment Of Oral Lichen Planus

NCT06327620 | Recruiting

• 1 other identifier: A002021015
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

lichen planus; Treatment

Outcome Measures

Primary Outcomes (1)

• Clinical Improvement of Oral Lichen Planus Lesions

  Assessment of the degree of clinical improvement based on the reduction in the severity of oral lichen planus lesions.

  End of the second and fourth weeks of treatment.

Secondary Outcomes (2)

• Objective Response Score

  End of the second and fourth weeks of treatment

• Subjective Response Score

  Start of the study and at the end of the second and fourth weeks of treatment.

Study Arms (2)

Daivobet Ointment

EXPERIMENTAL

Daivobet Ointment Arm: Patients in this arm will be asked to topically apply Daivobet ointment three times daily for four weeks

Combination Product: Daivobet ointment, topical steroids

Topical steroids

ACTIVE COMPARATOR

Patients in this arm will be asked to topically apply a steroid ointment three times daily for four weeks.

Combination Product: Daivobet ointment, topical steroids

Interventions

Daivobet ointment, topical steroids COMBINATION_PRODUCT

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.

Daivobet Ointment; Topical steroids

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 30-60 years. Clinical signs and symptoms of bilateral intra-oral erosive lichen planus. History of unresponsiveness to currently available therapy. Histopathological confirmation by incisional biopsy. Willingness to topically apply Daivobet ointment in one side and topical steroid in the other side three times daily for 4 weeks.

You may not qualify if:

• Histological signs of dysplasia. Use of drugs possibly causing a lichenoid reaction. Lesions in contact with dental amalgam restorations. Any topical or systemic medications used in the treatment of oral lichen planus within four weeks before the study.
• History of hypersensitivity to the drug used in the current study.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University, Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Lichen Planus

Interventions

Steroids

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Wafaa saleh, Ph.D

CONTACT

01030539617; wafaasaid@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: January 15, 2022
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)