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

Oral Lichen Planus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106468
• Other study ID #: Elgendy - 1
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2014
• Last updated: April 26, 2015
• Start date: May 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2014
• Source: October 6 University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• 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 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.

Locations

Country	Name	City	State
Egypt	October 6 University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	6 months	Yes
Secondary	Recurrence of disease	Recurrence within the following 3 months was recorded.	3 months	Yes