The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus

Study Overview
=================
Brief Summary
-----------------
This study was initiated to evaluate the potential of dietary supplementation of omega-3 for providing an inexpensive, safe and effective therapeutic agent for managing atrophic/erosive lichen planus.

Official Title
-----------------
The Efficacy of Omega-3 in Treatment of Atrophic/Erosive Lichen Planus and Improvement of Quality of Life: A Randomized, Double Blind, Controlled Study

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

Intervention / Treatment
-----------------
* Drug: Prednisone tablet 5mg
* Drug: Omega-3 soft capsules 1000 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of OLP (Presence of painful and atrophic-erosive oral Lesions, bilateral, mostly symmetrical lesions, presence of lace-like network of slightly raised white lines). Age between 30-60 years Ability to complete the present clinical trial. Exclusion Criteria: Pregnant or breast feeding women (pregnancy test for women of child bearing age). Lichenoid reactions caused by certain drugs or dental amalgam. Therapy for oral lichen planus (OLP) in the 6 months prior to the study. Patient doesn't have hepatitis C [after the patients' medical histories were recorded, the patients were given hepatic screening as published elsewhere. 2 Presence of candidiasis before treatment. Patients with pre-existing diabetes or an initial random glucose level exceeding 200 mg/dL before initiating steroid therapy were excluded. Hypertensive patients Contraindications for corticosteroid use (immunodeficiency or severe heamatological alterations).

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prednisone 50 mg tablet<br>This group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks. | Drug: Prednisone tablet 5mg<br>* This group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks.<br>* Other names: Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy;|
| Active Comparator: Omega-3 capsules 1000 mg<br>This group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months. | Drug: Omega-3 soft capsules 1000 mg<br>* This group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months.<br>* Other names: Super Omega; Technopharma, Cairo, Egypt;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve quality of the life (Oral Health Impact Profile) | Improve quality of the life was recorded at baseline, 3 and 6 months after treatment. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size and types (atrophic/erosive) of the lesions | Size and types of the lesions were examined at the beginning of treatment, and then after 2 weeks, 1, 3, and 6 months of therapy. Score 5 = white striae with erosive area more than I cm Score 4 = white striae with erosive area less than 1 cm Score 3 = white striae with atrophic area more than I cm Score 2 = white striae with atrophic area less than I cm Score I =mild white striae, no erythematous area Score 0 = no lesion, normal mucosa | 6 months | 
| Pain score (Visual analogue scale (VAS)), | Pain score was recorded at the beginning of treatment, and then after 2 weeks, 1, 3, and 6 months of therapy. Scale 0: no pain: VAS=0 Scale 1: mild pain: 0< VAS≤3.5 Scale 2: moderate pain: 3.5 <VAS≤7 Scale 3: severe pain: 7< VAS≤10. | 6 months | 
| Recurrence of disease | Recurrence within the following 3 months was recorded. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oral Lichen Planus, Corticosteroid, Omega -3