Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus

Erosive Lichen Planus Clinical Trial

Official title:

Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus (A Randomized Clinical Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04652739
• Other study ID #: Lycopene and lichen planus
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 1, 2018
• Est. completion date: March 10, 2019

Study information

• Verified date: November 2020
• Source: University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 10, 2019
• Est. primary completion date: March 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erosive Lichen Planus
• Lichen Planus
• Lichen Planus, Oral

Intervention

Drug:
• Lycopene Softgel, 10 Mg
Patients were given 10 mg of lycopene softgel capsules once daily for two months. The active ingredient in each capsule consists of 10 mg lycopene from natural tomato extract.
• Prednisolone
Patients were given 40 mg of prednisolone tablets once daily in the morning for one month, afterwards, the dose was tapered along the following month. Incremental reduction of 10 mg each week for the first three weeks, followed by 5 mg reduction in the last week, was the tapering protocol in this study. The active ingredient in each tablet consists of Prednisolone metasulfobenzoate sodium 31.44 mg (equivalent to 20 mg of Prednisolone).

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (2)

Lead Sponsor	Collaborator
Nourhan M.Aly	Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Gobbo M, Rupel K, Zoi V, Perinetti G, Ottaviani G, Di Lenarda R, Bevilacqua L, Woo SB, Biasotto M. Scoring systems for Oral Lichen Planus used by differently experienced raters. Med Oral Patol Oral Cir Bucal. 2017 Sep 1;22(5):e562-e571. doi: 10.4317/medoral.21833. — View Citation

Thongprasom K, Luangjarmekorn L, Sererat T, Taweesap W. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med. 1992 Nov;21(10):456-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment was conducted using Visual Analogue Scale (VAS)	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.	up to 5 months
Primary	Lesion size assessment	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.	up to 5 months