Clinical Trial: Treatmant of Oral Lichen Planus With Lycopene
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Efficacy of Oral Lycopene in the Management of Oral Lichen Planus
Brief Summary:
the purpose of this study was to evaluate that if lycopene, a potent antioxidant can be used in the treatment of oral lichen planus. this could be useful as lycopene has no reported side effects and hence it can used in place of steroids which are commonly used for this condition and have many reported adverse effects.
lycopene can be used in the treatment of this condition as free radicals have been found to play a role in the cause of this disease and also lower levels of lycopene were seen in these patints.
Detailed Summary:
Lichen planus, a chronic inflammatory mucocutaneous disease, occurs in about 2% of the adult population, affecting the skin and or oral mucosa. Clinically, lichen planus appears in keratotic, atrophic or erosive form. The atrophic and erosive forms are usually symptomatic.
Various treatment modalities viz. corticosteroids, antimicrobials, immunomodulators, phenytoin, retinoids, UV-radiation and surgical treatment etc. have been tried. Though none of these have shown to achieve satisfactory results with recurrence of lesion occurring in most of the cases after few weeks of discontinuation of therapy.
Recently a population based case control study has revealed lower levels of lycopene in atrophic and erosive oral lichen planus cases, while no significant difference was noted in any other carotenoid levels.
Lycopene is an antioxidant and free radical scavenger being used in the management of infertility, pre-eclampsia, cataract prevention, osteoarthritis, as adjuvant therapy in various malignancies, cardiovascular disorders, diabetes mellitus, aging, Alzheimer's disease, parkinsonism, etc.
Systemic lycopene has been found to be effective in treatment of oral leukoplakia, owing to its antioxidant properties.
The utility of lycopene in oral lichen planus has not been reported in the literature; therefore, this study has been designed to assess the efficacy of systemic lycopene in management of oral lichen planus patients.
The data collected from this study can move us closer to deriving a specific treatment plan for oral lichen planus - a dividend, not only for patients but dental fraternity as well.
Sponsor: College of Dental Sciences, India
Current Primary Outcome: Relief from signs & symptoms of disease [ Time Frame: 08 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Relief from signs & symptoms of disease [ Time Frame: 08 weeks ]
Original Secondary Outcome: Same as current
Information By: College of Dental Sciences, India
Dates:
Date Received: April 4, 2008
Date Started: December 2004
Date Completion:
Last Updated: April 9, 2008
Last Verified: November 2004
