Evaluation of Mucoadhesive Tacrolimus Patch on Caspase-3 Inducing Apoptosis in Oral Lichen Planus

Study Overview
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Brief Summary
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tacrolimus has been widely used as an immunosuppressant. the objective of this study was to evaluate the clinical efficacy of tacrolimus 0.1 % in muco adhesive patch compared to tacrolimus or corticosteroids in paste forms for symptomatic oral lichen planus, and to investigate the effect of topical tacrolimus or corticosteroids on the expression of caspase-3 in oral lichen planus as an early marker of apoptosis using immunohistochemically analysis

Detailed Description
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thirty patients with erosive or atrophic OLP were randomly assigned into three equal groups to receive topical steroid ( triamcinolone acetonide 0.1%), four times per day ( Group 1), tacrolimus paste 0.1% four times per day ( Group 2) , and tacrolimus patch 2 times per day ( Group 3). all groups are given treatment for 8 weeks and 4 weeks follow up period without treatment. Photographs of the most severe lesion were taken ( marker lesion ) in each patient and analyzed for total ulcerative area (TUA), total atrophic area (TAA). patients were also assessed using clinical scores (CS) and visual analogue scale (VAS). pre treatment and post treatment specimens were immunohistochemically stained to detect expression of caspase-3.

Official Title
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Evaluation of Mucoadhesive Tacrolimus Patch on Caspase-3 Inducing Apoptosis in Oral Lichen Planus ( A Randomized Controlled Clinical Trial With Immunohistochemical Analysis)

Conditions
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Oral Lichen Planus

Intervention / Treatment
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* Drug: Corticosteroid Topical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinically and histologically proven painful bullous/erosive or atrophic forms of OLP Exclusion Criteria: lichenoid lesions smoking systemic conditions pregnancy or breast feeding known hypersnstivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation

Ages Eligible for Study
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Minimum Age: 25 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
Interventional Model Description: treatment of oral lichen planus
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tacrolimus/corticosteroid<br>topical steroids ( triamcinolone acetonide 0.1 %), tacrolimus paste and tacrolimus patch | Drug: Corticosteroid Topical<br>* topical tacrolimus and corticosteroids<br>* Other names: tacrolimus paste and patch topical;|
| Active Comparator: corticosteroids<br>topical corticosteroid | Drug: Corticosteroid Topical<br>* topical tacrolimus and corticosteroids<br>* Other names: tacrolimus paste and patch topical;|
| Active Comparator: tacrolimus<br>topical tacrolimus patch and tacrolimus paste | Drug: Corticosteroid Topical<br>* topical tacrolimus and corticosteroids<br>* Other names: tacrolimus paste and patch topical;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical score | 0 represnted no lesion/normal mucosa, 1 mild white stria / no erythematous area | change from baseline at 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caspase-3 | caspase-3 cells count in immunostained section | change from base line at 8 weeks |