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

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

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

Study Overview

• Status: Completed
• Conditions: Oral Lichen Planus
• Intervention / Treatment: Drug: Corticosteroid Topical

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Noha Dawoud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tacrolimus/corticosteroid; topical steroids ( triamcinolone acetonide 0.1 %), tacrolimus paste and tacrolimus patch	Drug: Corticosteroid Topical; topical tacrolimus and corticosteroids; Other Names: tacrolimus paste and patch topical
Active Comparator: corticosteroids; topical corticosteroid	Drug: Corticosteroid Topical; topical tacrolimus and corticosteroids; Other Names: tacrolimus paste and patch topical
Active Comparator: tacrolimus; topical tacrolimus patch and tacrolimus paste	Drug: Corticosteroid Topical; topical tacrolimus and corticosteroids; Other Names: tacrolimus paste and patch topical

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Actual): October 20, 2021
• Study Completion (Actual): October 20, 2021

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: November 18, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Stomatognathic Diseases; Mouth Diseases; Skin Diseases, Papulosquamous; Lichenoid Eruptions; Lichen Planus, Oral; Lichen Planus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: FDASU-RECD123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No