Clinical trial NCT02587117: A Clinical Trial to Study the Effects of Two Drugs, Lycopene and Prednisolone in Patients With Oral Lichen Planus
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Oral Lichen Planus
Keywords: Antioxidant
Lycopene
Prednisolone
Lead sponsor: B.P. Koirala Institute of Health Sciences
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score
timeFrame: 8 weeks minus baseline
Secondary outcomes:
measure: Burning Sensation or Pain by Using NRS (Numerical Rating Scale)
timeFrame: 8 weeks minus baseline
Other outcomes:
Locations:
Study officials:
affiliation: B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan, Nepal
name: Ramayan Pr Kushwaha, MD
role: PRINCIPAL_INVESTIGATOR
References: