Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus

Study Overview
=================
Brief Summary
-----------------
Lichen Planus (LP) is a chronic mucocutaneous inflammatory disease and considered as T-cell mediated autoimmune disorder. Zinc is a potent antioxidant micronutrient that contributes to the proper functioning of the antioxidant defense system. In addition, this mineral protects cells against inflammation by oxidative stress, because it acts in the stabilization of cell membrane. It also maintains macrophage and neutrophil functions, natural killer cell activity, and complement activity. Matrix metalloproteinases (MMPs) are a family of zinc-containing endopeptidases and have the main function of proteolytic degradation of connective tissue matrix proteins. Zinc prevents (MMP-1) activation and inhibition of the T-cell accumulation in (OLP) through inhibiting of (MMP-9). Aim of the study: To evaluate and compare the efficacy of adding oral zinc supplementation 50 mg to 0.1%Triamcinolone orabase (TA)versus 0.1%Triamcinolone orabase alone on the healing of erosive OLP.

Official Title
-----------------
Efficacy of Oral Zinc Supplement as an Adjunctive Therapy for Erosive Oral Lichen Planus (a Randomized, Controlled Clinical Trial)

Conditions
-----------------
Oral Lichen Planus

Intervention / Treatment
-----------------
* Drug: Oral zinc supplement
* Drug: triamcinolone acetonide Oral paste


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients involved in this clinical trial will have symptomatic OLP Exclusion Criteria: Smokers or tobacco users will be excluded from this clinical trial. Pregnant and lactating females. Any patient that has history of cancer, kidney, liver or other autoimmune disease will be excluded from this study. Patients showing dysplastic changes in their confirmatory biopsy specimen will be also excluded. Any patients presenting with extra oral lichen planus lesions will be excluded. Suspicious lesions of both lichenoid contact reaction and lichenoid drug reaction lesions will be excluded. Vitamin administration intake within the last 3 months

Ages Eligible for Study
-----------------
Minimum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br> | Drug: Oral zinc supplement<br>* patients received oral Zinc picolinate 50mg for 6 weeks as single morning dose along with 0.1%<br>|
| Active Comparator: control group<br> | Drug: triamcinolone acetonide Oral paste<br>* patients will received 0.1%triamcinolone acetonide Oral paste twice daily alone for 6weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in oral lesions | Thongprasom scoring system will be used for the measurement of objective outcomes; score 5 was assigned to patients having white striae with erosive areas >1 cm2, score 4 assigned to patients with white striae and erosive areas <1 cm2, score 3 assigned to those having white striae and atrophic areas >1 cm2, score 2 assigned to those having white striae and atrophic areas <1 cm2, score 1 assigned to those having only white striae, and score 0 assigned to normal mucosa. | Baseline, 6 weeks, 12 weeks | 
| Change in MMP-9 level | Whole unstimulated saliva will be collected from all participants | Baseline, 6 weeks, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain | Patients will be asked to assign a numerical score representing the intensity of their symptoms on a scale from 0 to 10, with 0 being no symptoms and 10 being worst imaginable symptoms | Baseline, 6 weeks, 12 weeks |