A Clinical Trial to Study the Effects of Two Drugs, Lycopene and Prednisolone in Patients With Oral Lichen Planus (OLP)
Primary Purpose
Oral Lichen Planus
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
lycopene
Prednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Oral Lichen Planus focused on measuring Antioxidant, Lycopene, Prednisolone
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
lycopene group
Prednisolone group
Arm Description
Lycopene- 4 mg capsule by mouth single dose per day for 2 months
Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02587117
First Posted
October 20, 2015
Last Updated
January 26, 2016
Sponsor
B.P. Koirala Institute of Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02587117
Brief Title
A Clinical Trial to Study the Effects of Two Drugs, Lycopene and Prednisolone in Patients With Oral Lichen Planus
Acronym
OLP
Official Title
Comparative Study of the Efficacy of Lycopene Versus Prednisolone in the Management of Oral Lichen Planus: A Randomized, Double Blind Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
B.P. Koirala Institute of Health Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
Antioxidant, Lycopene, Prednisolone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lycopene group
Arm Type
Experimental
Arm Description
Lycopene- 4 mg capsule by mouth single dose per day for 2 months
Arm Title
Prednisolone group
Arm Type
Active Comparator
Arm Description
Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
Intervention Type
Drug
Intervention Name(s)
lycopene
Other Intervention Name(s)
lycored
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Other Intervention Name(s)
wysolone
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score
Description
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.
Time Frame
8 weeks minus baseline
Secondary Outcome Measure Information:
Title
Burning Sensation or Pain by Using NRS (Numerical Rating Scale)
Description
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.
Time Frame
8 weeks minus baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramayan Pr Kushwaha, MD
Organizational Affiliation
B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan, Nepal
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
A Clinical Trial to Study the Effects of Two Drugs, Lycopene and Prednisolone in Patients With Oral Lichen Planus
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