Evaluation of Lycopene in the Treatment of Erosive Oral Lichen Planus
NCT ID: NCT04652739
Last Updated: 2020-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
20 participants
INTERVENTIONAL
2018-10-01
2019-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Lycopene
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.
Corticosteroids
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).
Interventions
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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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
30 Years
60 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Nourhan M.Aly
OTHER
Responsible Party
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Nourhan M.Aly
Assistant Lecturer of Dental Public Health
Principal Investigators
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Aliaa A Bedeir, BDS
Role: PRINCIPAL_INVESTIGATOR
Faculty of Dentistry, Alexandria University, Egypt
Azza M Zaki, PhD
Role: STUDY_DIRECTOR
Faculty of Dentistry, Alexandria University, Egypt
Sabah A Mahmoud, PhD
Role: STUDY_DIRECTOR
Faculty of Medicine, Alexandria University, Egypt
Locations
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Faculty of Dentistry, Alexandria University
Alexandria, , Egypt
Countries
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References
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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. doi: 10.1111/j.1600-0714.1992.tb00974.x.
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.
Other Identifiers
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Lycopene and lichen planus
Identifier Type: -
Identifier Source: org_study_id