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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Oral Lichen Planus

Treatments: Drug: Corticosteroid Topical

Study type: Interventional

Funder types: Other

Identifiers

NCT05139667

FDASU-RECD123

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 25 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups

tacrolimus/corticosteroid

Experimental group

Description:

topical steroids ( triamcinolone acetonide 0.1 %), tacrolimus paste and tacrolimus patch

Treatment:

Drug: Corticosteroid Topical

corticosteroids

Active Comparator group

Description:

topical corticosteroid

Treatment:

Drug: Corticosteroid Topical

tacrolimus

Active Comparator group

Description:

topical tacrolimus patch and tacrolimus paste

Treatment:

Drug: Corticosteroid Topical