Treatmant of Oral Lichen Planus With Lycopene

This study has been completed.
Sponsor:
Information provided by:
College of Dental Sciences, India
ClinicalTrials.gov Identifier:
NCT00656214
First received: April 4, 2008
Last updated: April 9, 2008
Last verified: November 2004
  Purpose

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.


Condition Intervention Phase
Lichen Planus, Oral
Drug: Lycopene
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Oral Lycopene in the Management of Oral Lichen Planus

Resource links provided by NLM:


Further study details as provided by College of Dental Sciences, India:

Primary Outcome Measures:
  • Relief from signs & symptoms of disease [ Time Frame: 08 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relief from signs & symptoms of disease [ Time Frame: 08 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: December 2004
Study Completion Date: July 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Patients with symptomatic oral lichen planus
Drug: Lycopene
08 mg/day in two divided dosage
Other Name: Lycored (Jagsonpal Pharmaceuticles, India)
Placebo Comparator: B
Patients with symptomatic oral lichen planus
Drug: Placebo
Two divided dosage

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656214

Locations
India
Department of oral medicine & radiology, College of dental sciences
Davangere, Karnataka, India, 577004
Sponsors and Collaborators
College of Dental Sciences, India
Investigators
Study Director: Dr MC Shashikanth, MDS Professor & Head of Department, Department of Oral Medicine & Radiology, College of Dental Sciences, Davangere, Karnataka, India
  More Information

Publications:
Responsible Party: College of Dental Sciences, India
ClinicalTrials.gov Identifier: NCT00656214     History of Changes
Other Study ID Numbers: olplycopene
Study First Received: April 4, 2008
Last Updated: April 9, 2008
Health Authority: India: Institutional Review Board

Keywords provided by College of Dental Sciences, India:
Lichen Planus

Additional relevant MeSH terms:
Lichen Planus
Lichen Planus, Oral
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Lycopene
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Radiation-Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014