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Treatmant of Oral Lichen Planus With Lycopene

Primary Purpose

Lichen Planus, Oral

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Lycopene
Placebo
Sponsored by
College of Dental Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Planus, Oral focused on measuring Lichen Planus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients who were physically healthy and well oriented in time space and as a person.
  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:

  1. Patients suffering from any systemic disease/s like Diabetes, Hypertension, Cardiovascular system disease, Renal dysfunction, Liver disorders etc.
  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.

Sites / Locations

  • Department of oral medicine & radiology, College of dental sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A

B

Arm Description

Patients with symptomatic oral lichen planus

Patients with symptomatic oral lichen planus

Outcomes

Primary Outcome Measures

Relief from signs & symptoms of disease

Secondary Outcome Measures

Relief from signs & symptoms of disease

Full Information

First Posted
April 4, 2008
Last Updated
April 9, 2008
Sponsor
College of Dental Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT00656214
Brief Title
Treatmant of Oral Lichen Planus With Lycopene
Official Title
Efficacy of Oral Lycopene in the Management of Oral Lichen Planus
Study Type
Interventional

2. Study Status

Record Verification Date
November 2004
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
College of Dental Sciences, India

4. Oversight

5. Study Description

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 Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lichen Planus, Oral
Keywords
Lichen Planus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Patients with symptomatic oral lichen planus
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Patients with symptomatic oral lichen planus
Intervention Type
Drug
Intervention Name(s)
Lycopene
Other Intervention Name(s)
Lycored (Jagsonpal Pharmaceuticles, India)
Intervention Description
08 mg/day in two divided dosage
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two divided dosage
Primary Outcome Measure Information:
Title
Relief from signs & symptoms of disease
Time Frame
08 weeks
Secondary Outcome Measure Information:
Title
Relief from signs & symptoms of disease
Time Frame
08 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who were physically healthy and well oriented in time space and as a person. Patients clinically & histopathologically diagnosed to be suffering from oral lichen planus. Patients who had symptoms i.e. pain and/or burning sensation secondary to oral lichen planus. 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. Patients who agreed to take medication supplied. 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. Patients who agreed for the biopsy and hematological examination. Exclusion Criteria: Patients suffering from any systemic disease/s like Diabetes, Hypertension, Cardiovascular system disease, Renal dysfunction, Liver disorders etc. Patients with any other mucosal disease or any other skin disease which may be associated with oral lesions. Patients on any drug therapy which may cause lichen planus like lesions. Patients with findings of any physical or mental abnormality, which would interfere with or be affected by the study procedure. Patients with a known allergy or contraindication to study medications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr MC Shashikanth, MDS
Organizational Affiliation
Professor & Head of Department, Department of Oral Medicine & Radiology, College of Dental Sciences, Davangere, Karnataka, India
Official's Role
Study Director
Facility Information:
Facility Name
Department of oral medicine & radiology, College of dental sciences
City
Davangere
State/Province
Karnataka
ZIP/Postal Code
577004
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
11334461
Citation
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.
Results Reference
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PubMed Identifier
12946243
Citation
Lycopene. Monograph. Altern Med Rev. 2003 Aug;8(3):336-42. No abstract available.
Results Reference
background
PubMed Identifier
15063387
Citation
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.
Results Reference
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Treatmant of Oral Lichen Planus With Lycopene

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