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

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

Detailed Description
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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).

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

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Drug: Topical pomegranate seeds and peel extracts


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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<br>* Topical pomegranate seeds and peel extracts in the form of gel<br>|
| Experimental: Group S<br>Topical pomegranate seeds extract treatment has been repeated four times per day for four weeks. | Drug: Topical pomegranate seeds and peel extracts<br>* Topical pomegranate seeds and peel extracts in the form of gel<br>|
| Experimental: Group P<br>Topical pomegranate peel extract treatment has been repeated four times per day for four weeks. | Drug: Topical pomegranate seeds and peel extracts<br>* Topical pomegranate seeds and peel extracts in the form of gel<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pomegranate, seeds, peel, topical, Oral lichen planus, pain, OHIP-14.