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

• ClinicalTrials.gov Identifier: NCT04193748
• Recruitment Status: Completed
• First Posted: December 10, 2019
• Last Update Posted: February 5, 2020
• Sponsor: Cairo University
• Information provided by (Responsible Party): Mai Zakaria Ibrahium Mohammed, Cairo University

Study Description

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).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Egypt

Oral Medicine and Periodontology Department

Cairo, Egypt

Faculty of Dentistry, Cairo University

Giza, Egypt

Sponsors and Collaborators

Cairo University

More Information

• 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
• 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.

• 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:

Lichen Planus, Oral; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Mouth Diseases; Stomatognathic Diseases