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

Oral Lichen Planus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04193748
• Other study ID #: FacultyofDentistryCairoUni
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2019
• Est. completion date: December 13, 2019

Study information

• Verified date: January 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 13, 2019
• Est. primary completion date: November 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lichen Planus
• Lichen Planus, Oral
• Oral Lichen Planus

Intervention

Drug:
• Topical pomegranate seeds and peel extracts
Topical pomegranate seeds and peel extracts in the form of gel

Locations

Country	Name	City	State
Egypt	Oral Medicine and Periodontology Department	Cairo
Egypt	Faculty of Dentistry, Cairo University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual analog scale (VAS)	Pain assessment scale	4 weeks
Secondary	Sign score	Score for clinical improvement of the signs	4 weeks
Secondary	OHIP-14 questionnaire	evaluate the oral health related quality of life	4 weeks