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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: October 6 University

Current Primary Outcome: Improve quality of the life (Oral Health Impact Profile) [ Time Frame: 6 months ]

Improve quality of the life was recorded at baseline, 3 and 6 months after treatment.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Size and types (atrophic/erosive) of the lesions [ Time Frame: 6 months ]

    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)), [ Time Frame: 6 months ]

    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 [ Time Frame: 3 months ]
    Recurrence within the following 3 months was recorded.


Original Secondary Outcome: Same as current

Information By: October 6 University

Dates:
Date Received: March 21, 2014
Date Started: May 2013
Date Completion:
Last Updated: April 26, 2015
Last Verified: March 2014