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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
B.P. Koirala Institute of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring Antioxidant, Lycopene, Prednisolone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 20, 2015
    Last Updated
    January 26, 2016
    Sponsor
    B.P. Koirala Institute of Health Sciences
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    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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