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

Cairo University (CU)

Status and phase: Completed; Phase 4

Conditions: Oral Lichen Planus

Treatments: Drug: Topical pomegranate seeds and peel extracts

Study type: Interventional

Funder types: Other

Identifiers

NCT04193748

FacultyofDentistryCairoUni

Details and patient eligibility

About

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

Full 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).

Enrollment: 42 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

42 participants in 3 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Drug: Topical pomegranate seeds and peel extracts

Group S

Experimental group

Description:

Topical pomegranate seeds extract treatment has been repeated four times per day for four weeks.

Treatment:

Drug: Topical pomegranate seeds and peel extracts

Group P

Experimental group

Description:

Topical pomegranate peel extract treatment has been repeated four times per day for four weeks.

Treatment:

Drug: Topical pomegranate seeds and peel extracts