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

Phase 4

Completed

• Conditions: Oral Lichen Planus
• Interventions: Drug: Corticosteroid Topical

• Registration Number: NCT05139667
• Lead Sponsor: Ain Shams University

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-05-20
• Primary Completion: 2021-10-20
• Study Completion: 2021-10-20
• Status Verified: 2021-11
• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2021-11-18
• Last Update Submitted: 2021-11-18
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• clinically and histologically proven painful bullous/erosive or atrophic forms of OLP

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
corticosteroids	Corticosteroid Topical	topical corticosteroid
tacrolimus	Corticosteroid Topical	topical tacrolimus patch and tacrolimus paste
tacrolimus/corticosteroid	Corticosteroid Topical	topical steroids ( triamcinolone acetonide 0.1 %), tacrolimus paste and tacrolimus patch

Primary Outcome Measures

Name	Time	Method
clinical score	change from baseline at 12 weeks	"0" represnted no lesion/normal mucosa, "1" mild white stria / no erythematous area

Secondary Outcome Measures

Name	Time	Method
caspase-3	change from base line at 8 weeks	caspase-3 cells count in immunostained section

Trial Locations

Locations (1)

Noha Dawoud; 🇪🇬 Cairo, Egypt