Lichen Planus, OralPhase 2NCT00656214
Treatmant of Oral Lichen Planus With Lycopene
A Phase 2 study testing Lycopene in people with Lichen Planus, Oral, run by College of Dental Sciences, India at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lichen Planus, Oral
- What is being tested?
- Lycopene
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2004to Jul 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Department of oral medicine & radiology, College of dental sciences
Davangere, Karnataka, 577004
About this study
Official title: Efficacy of Oral Lycopene in the Management of Oral Lichen Planus
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.
Read the 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.
- Conditions
- Lichen Planus, Oral
- Being tested
- Lycopene, Placebo
- Keywords
- Lichen Planus
- Medical subject headings
- Lichen Planus, Oral, Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LycopeneDrug
Also called Lycored (Jagsonpal Pharmaceuticles, India)
08 mg/day in two divided dosage
PlaceboDrug
Two divided dosage
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Patients with symptomatic oral lichen planus Receives: Drug: Lycopene |
| B | Placebo comparator | Patients with symptomatic oral lichen planus Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relief from signs & symptoms of disease
Measured: 08 weeks
Secondary outcomes (1)
Relief from signs & symptoms of disease
Measured: 08 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startDec 2004
- Primary completionMay 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lichen Planus, OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- College of Dental Sciences, India
- Sponsor type
- University, hospital or other
- Investigators
- Dr MC Shashikanth, MDS, Study director, Professor & Head of Department, Department of Oral Medicine & Radiology, College of Dental Sciences, Davangere, Karnataka, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656214
- Sponsor's protocol ID
- olplycopene
- Status last verified
- Nov 2004
- First submitted
- 4 Apr 2008
- Last updated
- 10 Apr 2008
- Results posted
- No
Publications
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.
PubMed 11334461Lycopene. Monograph. Altern Med Rev. 2003 Aug;8(3):336-42. No abstract available.
PubMed 12946243Singh 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.
PubMed 15063387
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral Lycopene in the Management of Oral Lichen Planus
- ClinicalTrials.gov ID
- NCT00656214
- Acronym / sponsor ID
- olplycopene
- Conditions
- Lichen Planus, Oral
- Keywords
- Lichen Planus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- College of Dental Sciences, IndiaUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- May 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 10 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: LycopenePatients with symptomatic oral lichen planus |
| B | Placebo comparator | Drug: PlaceboPatients with symptomatic oral lichen planus |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LycopeneAlso: Lycored (Jagsonpal Pharmaceuticles, India)08 mg/day in two divided dosage | Drug | A |
| PlaceboTwo divided dosage | Drug | B |
Primary outcome
Relief from signs & symptoms of disease
Time frame: 08 weeks
1 secondary outcome
Relief from signs & symptoms of disease
Time frame: 08 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2008.
- Background: PubMed 11334461Nagao 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.
- Background: PubMed 12946243Lycopene. Monograph. Altern Med Rev. 2003 Aug;8(3):336-42. No abstract available.
- Background: PubMed 15063387Singh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr MC Shashikanth, MDS study director
Professor & Head of Department, Department of Oral Medicine & Radiology, College of Dental Sciences, Davangere, Karnataka, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lycopene in people with Lichen Planus, Oral, run by College of Dental Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relief from signs & symptoms of disease (time frame: 08 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00656214, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2008.