NCT00656214

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2008

Completed
Last Updated

April 10, 2008

Status Verified

November 1, 2004

Enrollment Period

1.4 years

First QC Date

April 4, 2008

Last Update Submit

April 9, 2008

Conditions

Lichen Planus, Oral

Keywords

Lichen Planus

Outcome Measures

Primary Outcomes (1)

  • Relief from signs & symptoms of disease

    08 weeks

Secondary Outcomes (1)

  • Relief from signs & symptoms of disease

    08 weeks

Study Arms (2)

A

ACTIVE COMPARATOR

Patients with symptomatic oral lichen planus

Drug: Lycopene

B

PLACEBO COMPARATOR

Patients with symptomatic oral lichen planus

Drug: Placebo

Interventions

LycopeneDRUG

08 mg/day in two divided dosage

Also known as: Lycored (Jagsonpal Pharmaceuticles, India)
A
PlaceboDRUG

Two divided dosage

B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of oral medicine & radiology, College of dental sciences

Davangere, Karnataka, 577004, India

Location

Related Publications (3)

  • 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.

    PMID: 11334461BACKGROUND

  • Lycopene. Monograph. Altern Med Rev. 2003 Aug;8(3):336-42. No abstract available.

    PMID: 12946243BACKGROUND

  • 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.

    PMID: 15063387BACKGROUND

MeSH Terms

Conditions

Lichen Planus, OralLichen Planus

Interventions

Lycopene

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesPigments, BiologicalBiological Factors

Study Officials

  • Dr MC Shashikanth, MDS

    Professor & Head of Department, Department of Oral Medicine & Radiology, College of Dental Sciences, Davangere, Karnataka, India

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 10, 2008

Study Start

December 1, 2004

Primary Completion

May 1, 2006

Study Completion

July 1, 2006

Last Updated

April 10, 2008

Record last verified: 2004-11

Locations

IN(1)