A Clinical Trial to Study the Effects of Two Drugs, Lycopene and Prednisolone in Patients With Oral Lichen Planus

Study Overview
=================
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).

Official Title
-----------------
Comparative Study of the Efficacy of Lycopene Versus Prednisolone in the Management of Oral Lichen Planus: A Randomized, Double Blind Clinical Trial

Conditions
-----------------
Oral Lichen Planus

Intervention / Treatment
-----------------
* Drug: lycopene
* Drug: Prednisolone


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lycopene group<br>Lycopene- 4 mg capsule by mouth single dose per day for 2 months | Drug: lycopene<br>* 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.<br>* Other names: lycored;|
| Active Comparator: Prednisolone group<br>Prednisolone- 40 mg capsule by mouth single dose per day for 2 months | Drug: Prednisolone<br>* 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.<br>* Other names: wysolone;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antioxidant, Lycopene, Prednisolone