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

B.P. Koirala Institute of Health Sciences

Status and phase

Completed

Phase 4

Conditions

Oral Lichen Planus

Treatments

Drug: Prednisolone

Drug: lycopene

Study type

Interventional

Funder types

Other

Identifiers

NCT02587117

636/069/070

Details and patient eligibility

About

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.

Full 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).

Enrollment

28 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.