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

Primary Purpose

Oral Lichen Planus

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Prednisone tablet 5mg
Omega-3 soft capsules 1000 mg
Sponsored by
October 6 University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus focused on measuring Oral Lichen Planus, Corticosteroid, Omega -3

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesAccepts 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).

Sites / Locations

  • October 6 University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

prednisone 50 mg tablet

Omega-3 capsules 1000 mg

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
Recurrence of disease
Recurrence within the following 3 months was recorded.

Full Information

First Posted
March 21, 2014
Last Updated
April 26, 2015
Sponsor
October 6 University
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1. Study Identification

Unique Protocol Identification Number
NCT02106468
Brief Title
The Efficacy of Omega-3 in Treatment of 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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
October 6 University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus
Keywords
Oral Lichen Planus, Corticosteroid, Omega -3

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
prednisone 50 mg tablet
Arm Type
Active Comparator
Arm 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.
Arm Title
Omega-3 capsules 1000 mg
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Prednisone tablet 5mg
Other Intervention Name(s)
Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Omega-3 soft capsules 1000 mg
Other Intervention Name(s)
Super Omega; Technopharma, Cairo, Egypt
Intervention 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.
Primary Outcome Measure Information:
Title
Improve quality of the life (Oral Health Impact Profile)
Description
Improve quality of the life was recorded at baseline, 3 and 6 months after treatment.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Size and types (atrophic/erosive) of the lesions
Description
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
Time Frame
6 months
Title
Pain score (Visual analogue scale (VAS)),
Description
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.
Time Frame
6 months
Title
Recurrence of disease
Description
Recurrence within the following 3 months was recorded.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enas Elgendy, ph.D
Organizational Affiliation
October 6 University
Official's Role
Principal Investigator
Facility Information:
Facility Name
October 6 University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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