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

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: Topical pomegranate seeds and peel extracts

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Oral Medicine and Periodontology Department
  • Giza, Egypt
    • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analog scale (VAS)	Pain assessment scale	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sign score	Score for clinical improvement of the signs	4 weeks
OHIP-14 questionnaire	evaluate the oral health related quality of life	4 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): December 13, 2019

Study Registration Dates

• First Submitted: December 8, 2019
• First Submitted That Met QC Criteria: December 8, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: pomegranate, seeds, peel, topical, Oral lichen planus, pain, OHIP-14.
• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus
• Other Study ID Numbers: FacultyofDentistryCairoUni

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Because the research not published yet.

Drug and device information, study documents

• 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