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NCT05139667 Clinical Trial

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

Oral Lichen Planus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05139667
Other study ID # FDASU-RECD123
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 20, 2019
Est. completion date October 20, 2021

Study information
Verified date November 2021
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date October 20, 2021
Est. primary completion date October 20, 2021
Accepts healthy volunteers No
Gender All
Age group 25 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Corticosteroid Topical
topical tacrolimus and corticosteroids

Locations
Country Name City State
Egypt Noha Dawoud Cairo

Sponsors (1)
Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary clinical score "0" represnted no lesion/normal mucosa, "1" mild white stria / no erythematous area change from baseline at 12 weeks
Secondary caspase-3 caspase-3 cells count in immunostained section change from base line at 8 weeks
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