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

NCT ID: NCT02587117

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2014-03-31

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).

Conditions

Oral Lichen Planus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

lycopene group

Lycopene- 4 mg capsule by mouth single dose per day for 2 months

Group Type: EXPERIMENTAL

lycopene

Intervention Type: DRUG

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.

Prednisolone group

Prednisolone- 40 mg capsule by mouth single dose per day for 2 months

Group Type: ACTIVE_COMPARATOR

Prednisolone

Intervention Type: DRUG

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.

Interventions

lycopene

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

Prednisolone

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.

Intervention Type: DRUG

Other Intervention Names

lycored; wysolone

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B.P. Koirala Institute of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Dr. Ramayan Prasad Kushwaha

assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramayan Pr Kushwaha, MD

Role: PRINCIPAL_INVESTIGATOR

B.P. Koirala Institute of Health Sciences (BPKIHS), Dharan, Nepal

Other Identifiers

636/069/070

Identifier Type: -

Identifier Source: org_study_id