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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04193748
Recruitment Status : Completed
First Posted : December 10, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Mai Zakaria Ibrahium Mohammed, Cairo University

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

Condition or disease Intervention/treatment Phase
Oral Lichen Planus Drug: Topical pomegranate seeds and peel extracts Phase 4

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: The clinical outcomes were assessed by an investigator masked about the treatment modality that has been used
Primary Purpose: Treatment
Official Title: Evaluation of Topical Pomegranate Extracts in Management of Oral Lichen Planus (A Randomized Clinical Trial)
Actual Study Start Date : September 1, 2019
Actual Primary Completion Date : November 20, 2019
Actual Study Completion Date : December 13, 2019

Arm Intervention/treatment
Active Comparator: Control group
Topical triamcinolone acetonide 0.1% available commercially (Kenacort- in orabase) has been used. Topical corticosteroid treatment has be repeated four times per day for four weeks.
Drug: Topical pomegranate seeds and peel extracts
Topical pomegranate seeds and peel extracts in the form of gel

Experimental: Group S
Topical pomegranate seeds extract treatment has been repeated four times per day for four weeks.
Drug: Topical pomegranate seeds and peel extracts
Topical pomegranate seeds and peel extracts in the form of gel

Experimental: Group P
Topical pomegranate peel extract treatment has been repeated four times per day for four weeks.
Drug: Topical pomegranate seeds and peel extracts
Topical pomegranate seeds and peel extracts in the form of gel




Primary Outcome Measures :
  1. visual analog scale (VAS) [ Time Frame: 4 weeks ]
    Pain assessment scale


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193748


Locations
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Egypt
Oral Medicine and Periodontology Department
Cairo, Egypt
Faculty of Dentistry, Cairo University
Giza, Egypt
Sponsors and Collaborators
Cairo University
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Responsible Party: Mai Zakaria Ibrahium Mohammed, Lecturer of Oral Medicine and Periodontology, Cairo University, Egypt, Cairo University
ClinicalTrials.gov Identifier: NCT04193748    
Other Study ID Numbers: FacultyofDentistryCairoUni
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Because the research not published yet.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Mai Zakaria Ibrahium Mohammed, Cairo University:
pomegranate, seeds, peel, topical, Oral lichen planus, pain, OHIP-14.
Additional relevant MeSH terms:
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Lichen Planus, Oral
Lichen Planus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Mouth Diseases
Stomatognathic Diseases