A Novel Alternative Treatment Of Oral Lichen Planus

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Mansoura University, Faculty of Dentistry
RECRUITING
Al Mansurah
Contact Information
Primary
Wafaa saleh, Ph.D
wafaasaid@mans.edu.eg
01030539617
Time Frame
Start Date: 2022-01-15
Estimated Completion Date: 2024-05-20
Participants
Target number of participants: 15
Treatments
Experimental: Daivobet Ointment
Daivobet Ointment Arm: Patients in this arm will be asked to topically apply Daivobet ointment three times daily for four weeks
Active_comparator: Topical steroids
Patients in this arm will be asked to topically apply a steroid ointment three times daily for four weeks.
Related Therapeutic Areas
Sponsors
Leads: Mansoura University

This content was sourced from clinicaltrials.gov