Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus

Phase 2

Completed

• Conditions: Erosive Lichen Planus
• Interventions: Drug: Lycopene Softgel, 10 Mg; Drug: Prednisolone

• Registration Number: NCT04652739
• Lead Sponsor: Nourhan M.Aly

Brief Summary

The aim of this study was to evaluate the effect of oral lycopene and systemic steroids in the treatment of erosive oral lichen planus and compare between the two therapeutic modalities.

Detailed Description

Twenty erosive lichen planus patients were recruited and randomly assigned in one of two groups, the test (lycopene) and control (corticosteroids) group.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-03-03
• Study Completion: 2019-03-10
• Status Verified: 2020-11
• Study First Submitted: 2020-11-26
• Study First Submitted QC: 2020-11-26
• Last Update Submitted: 2020-11-26
• Study First Posted: 2020-12-03
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Erosive oral lichen planus patients with severe and extensive painful erythematous, erosive and/ or ulcerative lesions who are in need for systemic corticosteroid therapy

Exclusion Criteria

• Pregnant females and smokers.
• Patients suggestive of having lichenoid contact/drug reactions.
• Patients suffering from any systemic disease as diabetes, liver disease, renal disease, any other autoimmune or collagen disease.
• Lesions showing histological features of dysplasia.
• Patients with skin lichen planus lesions.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lycopene	Lycopene Softgel, 10 Mg	-
Corticosteroids	Prednisolone	-

Primary Outcome Measures

Name	Time	Method
Pain assessment was conducted using Visual Analogue Scale (VAS)	up to 5 months	Patients were instructed to mark a 10 cm line at a point equivalent to their present pain. The score was determined by measuring the distance in mm on the line from the "no pain" anchor to the patient's mark, providing a range of scores from 0-100. A Pain-free experience was scored zero, while the worst pain was scored 100.
Lesion size assessment	up to 5 months	Assessment of OLP lesions was performed using the Thongprasom et al. scoring index where: * Score 0: No lesion/Normal mucosa.; * Score 1: Mild white striae only.; * Score 2: White striae with erythematous area \<1cm².; * Score 3: White striae with erythematous area \>1cm².; * Score 4: White striae with erosive area \<1cm².; * Score 5: White striae with erosive area \>1cm².; * Scores from different oral sites were added to give a final score for every patient from 0-50.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt