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Completed

NCT Number: NCT02106468

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

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.

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Key information

Conditions

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

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

October 6 University

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy

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.

Other names: Super Omega; Technopharma, Cairo, Egypt

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. Recurrence of disease

    Time frame: 3 months

    Recurrence within the following 3 months was recorded.

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Apr 8, 2014
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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