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

NCT02106468 | Completed Phase 2 DMC

• 1 other identifier: Elgendy - 1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Lichen Planus

Keywords

Oral Lichen Planus; Corticosteroid; Omega -3

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Size and types (atrophic/erosive) of the lesions

  6 months

• Pain score (Visual analogue scale (VAS)),

  6 months

• Recurrence of disease

  3 months

Study Arms (2)

prednisone 50 mg tablet

ACTIVE COMPARATOR

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

Omega-3 capsules 1000 mg

ACTIVE COMPARATOR

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

Interventions

Prednisone tablet 5mg DRUG

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.

Also known as: Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy

prednisone 50 mg tablet

Omega-3 soft capsules 1000 mg DRUG

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.

Also known as: Super Omega; Technopharma, Cairo, Egypt

Omega-3 capsules 1000 mg

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

October 6 University

Cairo, Egypt

Location

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Enas Elgendy, ph.D

  October 6 University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecuture, October 6 University

Study Record Dates

• First Submitted: March 21, 2014
• First Posted: April 8, 2014
• Study Start: May 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: February 1, 2015
• Last Updated: April 28, 2015

Record last verified: 2014-03

Locations

EG (1)