Oral Lichen PlanusPhase 4OLPNCT02587117
A Clinical Trial to Study the Effects of Two Drugs, Lycopene and Prednisolone in Patients With Oral Lichen Planus
A Phase 4 study testing lycopene and Prednisolone in people with Oral Lichen Planus, run by B.P. Koirala Institute of Health Sciences.
Trial summary
Oral lichen planus (OLP) is a common sub-acute, chronic inflammatory mucocutaneous disease.This study was evaluated the comparative efficacy of lycopene and prednisolone for the treatment of oral lichen planus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Oral Lichen Planus
- What is being tested?
- lycopene and Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Mar 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject had symptomatic i.e. burning sensation and/or pain secondary to oral lichen planus.
- Subject had clinically \& histo-pathologically diagnosed as oral lichen planus.
- Subject had not on any treatment for the same or treatment likely to modify their oral lichen planus (e.g. systemic steroids, antifungals, immunosuppressant's, anti-oxidant).
Who cannot join
- Suffering from any systemic disease/s such as diabetes, hypertension, cardiovascular, respiratory system disease, renal dysfunction, liver disorders, malignancy, active peptic ulcer diseases, acute gastrointestinal diseases, anemia and glaucoma, etc.
- Suffering from serious or recurrent infection, immunodeficiency or HIV.
- Pregnant or breast feeding (including women who wish to be pregnant during the study period).
- Any other mucosal diseases or any other skin diseases which might be associated with oral lesions.
- On any drug therapy which might be causes lichen planus like lesions.
- Known allergy or contraindication to study medications.
About this study
Official title: Comparative Study of the Efficacy of Lycopene Versus Prednisolone in the Management of Oral Lichen Planus: A Randomized, Double Blind Clinical Trial
Oral lichen planus (OLP) is a common sub-acute, chronic inflammatory mucocutaneous disease.This study was evaluated the comparative efficacy of lycopene and prednisolone for the treatment of oral lichen planus. Half of participants (total number of participants was twenty eight) were received lycopene and the other half were received prednisolone.
Read the detailed description
Prednisolone and lycopene were produced remission of lesions in oral lichen planus patients, but they do so by different mechanisms.
The main cause of oral lichen planus is still unknown. Some authors advocate the disease appears to be a result of T-cell-mediated autoimmune responses in oral epithelial tissues. But, recent study suggests that increased reactive oxygen species (ROS) and lipid peroxidation together with an imbalance in the antioxidant defense system may play a part in the generation of disease.
Lycopene exerts its antioxidant activity by physical and chemical quenching of free radicals and decreases free radicals-initiated oxidative reactions, particularly lipid peroxidation and DNA oxidative damage, thereby preventing tissue damage.
Prednisone have both anti-inflammatory and immunosuppressant effects.It suppresses the inflammatory response by limiting the recruitment of inflammatory cells and inhibiting synthesis of pro-inflammatory products such as prostaglandins (PGs), leukotrienes (LTs) and platelet activating factors (PAF) by indirectly inhibiting phospholipase A2 and negative regulating cyclooxygenase (COX-2).
- Conditions
- Oral Lichen Planus
- Being tested
- lycopene, Prednisolone
- Keywords
- Antioxidant, Lycopene, Prednisolone
- Medical subject headings
- Lichen Planus, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lycopeneDrug
Also called lycored
Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.
PrednisoloneDrug
Also called wysolone
Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.
| Study group | Role | What they receive |
|---|---|---|
| lycopene group | Experimental | Lycopene- 4 mg capsule by mouth single dose per day for 2 months Receives: Drug: lycopene |
| Prednisolone group | Active comparator | Prednisolone- 40 mg capsule by mouth single dose per day for 2 months Receives: Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score
Reticular: score 0= no white striations; score 1= white striations. Erythematous: score 0= no lesion; score 1= lesion <1 cm2; score 2: lesion 1-3 cm2; score 3= lesion >3 cm2. Ulceration: score 0= no lesion; score 1= lesion <1 cm2; score 2= lesion 1-3 cm2; score 3= lesion >3 cm2. Total weighted score was derived by sum total scores of each lesion and multiplication with weighted score 1.5 \& 2.0 in total erythematous and total ulceration scores as ΣR + ΣE × 1.5 + ΣU × 2.0.Total weighted score was dependent on the number of lesions of each participant which was not the same across participants. Higher value of the total score represent worse outcome \& zero value represent no lesion.
Measured: 8 weeks minus baseline
Secondary outcomes (1)
Burning Sensation or Pain by Using NRS (Numerical Rating Scale)
Standard self-response Numerical Rating Scale (NRS) of 0 (no oral discomfort) to 10 (worst imaginable oral discomfort) to represent the intensity of burning sensation or pain or discomfort. The mean of NRS burning sensation score was calculated after eight weeks of treatment and considered as 8th week NRS burning sensation score.
Measured: 8 weeks minus baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startFeb 2013
- Primary completionJan 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Oral Lichen PlanusStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- B.P. Koirala Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ramayan Prasad Kushwaha, B.P. Koirala Institute of Health Sciences
- Investigators
- Ramayan Pr Kushwaha, MD, Principal investigator, B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587117
- Sponsor's protocol ID
- 636/069/070
- Acronym
- OLP
- Status last verified
- Jan 2016
- First submitted
- 20 Oct 2015
- Last updated
- 26 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Efficacy of Lycopene Versus Prednisolone in the Management of Oral Lichen Planus: A Randomized, Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT02587117
- Acronym / sponsor ID
- OLP / 636/069/070
- Conditions
- Oral Lichen Planus
- Keywords
- Antioxidant, Lycopene, Prednisolone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- B.P. Koirala Institute of Health SciencesUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Posted 26 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral lichen planus (OLP) is a common sub-acute, chronic inflammatory mucocutaneous disease.This study was evaluated the comparative efficacy of lycopene and prednisolone for the treatment of oral lichen planus. Half of participants (total number of participants was twenty eight) were received lycopene and the other half were received prednisolone.
Detailed description
Prednisolone and lycopene were produced remission of lesions in oral lichen planus patients, but they do so by different mechanisms.
The main cause of oral lichen planus is still unknown. Some authors advocate the disease appears to be a result of T-cell-mediated autoimmune responses in oral epithelial tissues. But, recent study suggests that increased reactive oxygen species (ROS) and lipid peroxidation together with an imbalance in the antioxidant defense system may play a part in the generation of disease.
Lycopene exerts its antioxidant activity by physical and chemical quenching of free radicals and decreases free radicals-initiated oxidative reactions, particularly lipid peroxidation and DNA oxidative damage, thereby preventing tissue damage.
Prednisone have both anti-inflammatory and immunosuppressant effects.It suppresses the inflammatory response by limiting the recruitment of inflammatory cells and inhibiting synthesis of pro-inflammatory products such as prostaglandins (PGs), leukotrienes (LTs) and platelet activating factors (PAF) by indirectly inhibiting phospholipase A2 and negative regulating cyclooxygenase (COX-2).
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 |
|---|---|---|
| lycopene group | Experimental | Drug: lycopeneLycopene- 4 mg capsule by mouth single dose per day for 2 months |
| Prednisolone group | Active comparator | Drug: PrednisolonePrednisolone- 40 mg capsule by mouth single dose per day for 2 months |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject had symptomatic i.e. burning sensation and/or pain secondary to oral lichen planus.
- Subject had clinically \& histo-pathologically diagnosed as oral lichen planus.
- Subject had not on any treatment for the same or treatment likely to modify their oral lichen planus (e.g. systemic steroids, antifungals, immunosuppressant's, anti-oxidant).
Key exclusion criteria (6 listed)
- Suffering from any systemic disease/s such as diabetes, hypertension, cardiovascular, respiratory system disease, renal dysfunction, liver disorders, malignancy, active peptic ulcer diseases, acute gastrointestinal diseases, anemia and glaucoma, etc.
- Suffering from serious or recurrent infection, immunodeficiency or HIV.
- Pregnant or breast feeding (including women who wish to be pregnant during the study period).
- Any other mucosal diseases or any other skin diseases which might be associated with oral lesions.
- On any drug therapy which might be causes lichen planus like lesions.
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: lycoredEach capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy. | Drug | lycopene group |
| PrednisoloneAlso: wysoloneEach capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy. | Drug | Prednisolone group |
Primary outcome
Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score
Time frame: 8 weeks minus baseline
Reticular: score 0= no white striations; score 1= white striations. Erythematous: score 0= no lesion; score 1= lesion <1 cm2; score 2: lesion 1-3 cm2; score 3= lesion >3 cm2. Ulceration: score 0= no lesion; score 1= lesion <1 cm2; score 2= lesion 1-3 cm2; score 3= lesion >3 cm2. Total weighted score was derived by sum total scores of each lesion and multiplication with weighted score 1.5 \& 2.0 in total erythematous and total ulceration scores as ΣR + ΣE × 1.5 + ΣU × 2.0.Total weighted score was dependent on the number of lesions of each participant which was not the same across participants. Higher value of the total score represent worse outcome \& zero value represent no lesion.
1 secondary outcome
Burning Sensation or Pain by Using NRS (Numerical Rating Scale)
Time frame: 8 weeks minus baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Oral Lichen Planus
RecruitingObservational study
Salivary IL-8 and Serum IL-6 as Biomarkers for Oral Potentially Malignant Disorders in Smokers and Never-Smokers
Oral Potentially Malignant Disorders, Oral Lichen Planus
Not yet recruiting
Curcumin-mediated Photodynamic Therapy Versus Photobiomodulation in the Treatment of Oral Erosive Lichen Planus
Oral Lichen Planus
Not yet recruiting
Adherence to Topical and Systemic Medications Among Symptomatic Oral Lichen Planus Patients: A Pilot Randomized Clinical Trial
Degree of Adherence of Symptomatic OLP Patients to Their Medications
Active, not recruitingPhase 4
Low Level Laser Therapy With Injectable Platelet Rich Fibrin in Management of Oral Lichen Planus
Oral Lichen Planus
Active, not recruiting
Widefield Fluorescence and Reflectance Imaging Systems and Oral Tissue Samples in Monitoring Participants at Risk for Developing Oral Cancer
Erythroplakia, Fanconi Anemia
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.
Ramayan Pr Kushwaha, MD principal investigator
B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan, Nepal
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lycopene and Prednisolone in people with Oral Lichen Planus, run by B.P. Koirala Institute of Health Sciences.
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 3 inclusion and 6 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 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score (time frame: 8 weeks minus baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2016.