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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lycopene group | Experimental | Lycopene- 4 mg capsule by mouth single dose per day for 2 months |
|
| Prednisolone group | Active Comparator | Prednisolone- 40 mg capsule by mouth single dose per day for 2 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lycopene | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks minus baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks minus baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramayan Pr Kushwaha, MD | B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan, Nepal | Principal Investigator |
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Before enrollment, full explanation about the study was given and written informed consent was taken. A detailed clinical history, clinical examination,baseline investigations and punch biopsy were taken. Patient was on treatment with medication for the same lesions asked to stop the treatment and a washout period of 3 weeks was given.
Only symptomatic oral lichen planus patients, who were fulfill inclusion and exclusion criteria, were selected and recruited from the outpatient department of Oral Medicine and Radiology, College of dental surgery, BPKIHS on the basis of randomization list. The first patients was recruited on 21/02/2013 and the last patients was on 28/01/2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lycopene Group | Lycopene- 4 mg capsule by mouth single dose per day for 2 months |
| FG001 | Prednisolone Group | Prednisolone- 40 mg capsule by mouth single dose per day for 2 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lycopene Group | Lycopene- 4 mg capsule by mouth single dose per day for 2 months |
| BG001 | Prednisolone Group | Prednisolone- 40 mg capsule by mouth single dose per day for 2 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Scores on a scale | 8 weeks minus baseline |
|
Daily monitoring throughout 8 weeks of treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lycopene Group | Lycopene- 4 mg capsule by mouth single dose per day for 2 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Puffiness of face | General disorders | MedDRA 10.0 | Systematic Assessment |
Due to limitation of time, there were small numbers of subjects enrollment; not possible to follow-up the cases after the treatments were over and to determine the relapse rate of the patients; performed at a single medical center.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ramayan Prasad Kushwaha | B.P. Koirala Institute of Health Sciences | 977-9842207716 | visitramayan007@yahoo.com |
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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| ID | Term |
|---|---|
| D000077276 | Lycopene |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
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|
| Prednisolone | Drug | 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. |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Piboonniyom REU (Reticular, Erythematous and Ulceration) severity score | Reticular:score 0=no white striations; score1= white striations. Erythematous:score 0=no lesion; score1= lesion <1 cm2; score2: lesion 1-3 cm2; score3= lesion >3 cm2. Ulceration:score 0=no lesion; score1= lesion <1 cm2; score2= lesion 1-3 cm2; score3= lesion >3 cm2. Total weighted score was sum total scores of each lesion & multiplication with weighted score 1.5 & 2.0 in total erythematous & total ulceration scores=ΣR+ΣE×1.5+ΣU×2.0. Total score was dependent on the number of lesions of each participant. Higher values of total score represent worse outcome & zero value represent no lesion. | Mean | Standard Deviation | Scores on a scale |
|
| Baseline NRS (numerical rating scale) burning sensation score | Each patient was provided standard self-response Numerical Rating Scale (NRS) of 0 (no oral discomfort) to 10 (worst imaginable oral discomfort) to respond the intensity of burning sensation or pain or discomfort during each visit. the mean of NRS burning sensation score was calculated and considered as baseline NRS burning sensation score. | Mean | Standard Deviation | Scores on a scale |
|
| OG001 | Prednisolone Group | Prednisolone- 40 mg capsule by mouth single dose per day for 2 months Prednisolone: 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. |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | Scores on a scale | 8 weeks minus baseline |
|
|
|
|
| 0 |
| 13 |
| 10 |
| 13 |
| EG001 | Prednisolone Group | Prednisolone- 40 mg capsule by mouth single dose per day for 2 months | 0 | 15 | 15 | 15 |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Blurred vision | Eye disorders | MedDRA 10.0 | Systematic Assessment |
|
| Flatulency | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Increased appetite | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Insomnia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |