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

Phase 2

Completed

• Conditions: Oral Lichen Planus
• Interventions: Drug: Prednisone tablet 5mg; Drug: Omega-3 soft capsules 1000 mg

• Registration Number: NCT02106468
• Lead Sponsor: October 6 University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Status Verified: 2014-03
• Study First Submitted: 2014-03-21
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-08
• Primary Completion: 2014-06
• Study Completion: 2015-02
• Last Update Submitted: 2015-04-26
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. 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).
2. Age between 30-60 years
3. Ability to complete the present clinical trial.

Exclusion Criteria

1. Pregnant or breast feeding women (pregnancy test for women of child bearing age).
2. Lichenoid reactions caused by certain drugs or dental amalgam.
3. Therapy for oral lichen planus (OLP) in the 6 months prior to the study.
4. Patient doesn't have hepatitis C [after the patients' medical histories were recorded, the patients were given hepatic screening as published elsewhere. 2
5. Presence of candidiasis before treatment.
6. Patients with pre-existing diabetes or an initial random glucose level exceeding 200 mg/dL before initiating steroid therapy were excluded.
7. Hypertensive patients
8. Contraindications for corticosteroid use (immunodeficiency or severe heamatological alterations).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prednisone 50 mg tablet	Prednisone tablet 5mg	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.
Omega-3 capsules 1000 mg	Omega-3 soft capsules 1000 mg	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.

Primary Outcome Measures

Name	Time	Method
Improve quality of the life (Oral Health Impact Profile)	6 months	Improve quality of the life was recorded at baseline, 3 and 6 months after treatment.

Secondary Outcome Measures

Name	Time	Method
Size and types (atrophic/erosive) of the lesions	6 months	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
Recurrence of disease	3 months	Recurrence within the following 3 months was recorded.
Pain score (Visual analogue scale (VAS)),	6 months	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.

Trial Locations

Locations (1)

October 6 University; 🇪🇬 Cairo, Egypt