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NCT Number: NCT04193748

Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)

This study was conducted to estimate the hypothesis that the Pomegranate Extracts have no role in management of oral lichen planus

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Key information

Conditions

Oral Lichen Planus Lichen Planus Lichen Planus, Oral Lichenoid Eruptions Mouth Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Oral Medicine and Periodontology Department, Cairo, Egypt

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About this study

Lichen planus is a common chronic mucocutaneous disease of uncertain origin that has been shown to affect 0.5% to 2.2% of various populations. The treatment options for OLP are numerous and include topical and systemic agents. Steroids were found effective in management of OLP with contraindicated use in some systemic diseases and with multiple side effects with its prolonged use. Pomegranates have been known for hundreds of years for their multiple health benefits, including anti-inflammatory activity. The recent surge indicates that pomegranates and their extracts may serve as natural alternatives to drugs which can offer a possible management of OLP decreasing pain and discomfort associated with this chronic condition.The aim of this study was the evaluation of the effect of topical pomegranate extracts in management of oral lichen planus lesions (OLP).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The study inclusion criteria were patients of both sexes with 18 to 60 years old in age with atrophic type OLP and signed the informed consent

Exclusion criteria

  • Patients who excluded from the study were smokers, pregnant, lactating ladies and patients under topical and systemic steroids during the last two months. Uncontrolled diabetic patients or hypertension in addition to hepatic and cardiac patients were not included. In addition, any previous history of allergy to pomegranate

Treatment and study plan

Topical pomegranate seeds and peel extracts

Drug

Topical pomegranate seeds and peel extracts in the form of gel

Primary outcomes

  1. visual analog scale (VAS)

    Time frame: 4 weeks

    Pain assessment scale

Secondary outcomes

  1. Sign score

    Time frame: 4 weeks

    Score for clinical improvement of the signs

  2. OHIP-14 questionnaire

    Time frame: 4 weeks

    evaluate the oral health related quality of life

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 10, 2019
Registry last updated
Feb 5, 2020

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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