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
Verified date | March 2014 |
Source | October 6 University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Egypt: Institutional Review Board |
Study type | Interventional |
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.
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). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Egypt | October 6 University | Cairo |
Lead Sponsor | Collaborator |
---|---|
October 6 University |
Egypt,
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 |
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