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
30 participants
INTERVENTIONAL
2004-12-31
2006-07-31
Brief Summary
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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 Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
Patients with symptomatic oral lichen planus
Lycopene
08 mg/day in two divided dosage
B
Patients with symptomatic oral lichen planus
Placebo
Two divided dosage
Interventions
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Lycopene
08 mg/day in two divided dosage
Placebo
Two divided dosage
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients clinically \& histopathologically diagnosed to be suffering from oral lichen planus.
3. Patients who had symptoms i.e. pain and/or burning sensation secondary to oral lichen planus.
4. Patients not on any treatment for the same. In case they were, then such treatment was stopped and a washout period of two weeks was given.
5. Patients who agreed to take medication supplied.
6. Patients who were willing for evaluation once in every two weeks for 8 weeks and also agreed to follow up every 30 days for 60 days.
7. Patients who agreed for the biopsy and hematological examination.
Exclusion Criteria
2. Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions.
3. Patients on any drug therapy which may cause lichen planus like lesions.
4. Patients with findings of any physical or mental abnormality, which would interfere with or be affected by the study procedure.
5. Patients with a known allergy or contraindication to study medications.
ALL
No
Sponsors
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College of Dental Sciences, India
OTHER
Principal Investigators
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Dr MC Shashikanth, MDS
Role: STUDY_DIRECTOR
Professor & Head of Department, Department of Oral Medicine & Radiology, College of Dental Sciences, Davangere, Karnataka, India
Locations
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Department of oral medicine & radiology, College of dental sciences
Davangere, Karnataka, India
Countries
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References
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Nagao T, Warnakulasuriya S, Ikeda N, Fukano H, Yamamoto S, Yano M, Miyazaki H, Ito Y. Serum antioxidant micronutrient levels in oral lichen planus. J Oral Pathol Med. 2001 May;30(5):264-7. doi: 10.1034/j.1600-0714.2001.300502.x.
Lycopene. Monograph. Altern Med Rev. 2003 Aug;8(3):336-42. No abstract available.
Singh M, Krishanappa R, Bagewadi A, Keluskar V. Efficacy of oral lycopene in the treatment of oral leukoplakia. Oral Oncol. 2004 Jul;40(6):591-6. doi: 10.1016/j.oraloncology.2003.12.011.
Other Identifiers
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olplycopene
Identifier Type: -
Identifier Source: org_study_id