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

October 6 University

Status and phase: Completed; Phase 2

Conditions: Oral Lichen Planus

Treatments: Drug: Omega-3 soft capsules 1000 mg; Drug: Prednisone tablet 5mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02106468

Elgendy - 1

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

prednisone 50 mg tablet

Active Comparator group

Description:

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.

Treatment:

Drug: Prednisone tablet 5mg

Omega-3 capsules 1000 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Omega-3 soft capsules 1000 mg