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

Primary Purpose

Oral Lichen Planus

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Corticosteroid Topical
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Lichen Planus

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Noha Dawoud

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

tacrolimus/corticosteroid

corticosteroids

tacrolimus

Arm Description

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

topical corticosteroid

topical tacrolimus patch and tacrolimus paste

Outcomes

Primary Outcome Measures

clinical score
"0" represnted no lesion/normal mucosa, "1" mild white stria / no erythematous area

Secondary Outcome Measures

caspase-3
caspase-3 cells count in immunostained section

Full Information

First Posted
November 18, 2021
Last Updated
November 18, 2021
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05139667
Brief Title
Evaluation of Mucoadhesive Tacrolimus Patch on Caspase-3 Inducing Apoptosis in Oral Lichen Planus
Official Title
Evaluation of Mucoadhesive Tacrolimus Patch on Caspase-3 Inducing Apoptosis in Oral Lichen Planus ( A Randomized Controlled Clinical Trial With Immunohistochemical Analysis)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2019 (Actual)
Primary Completion Date
October 20, 2021 (Actual)
Study Completion Date
October 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Lichen Planus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
treatment of oral lichen planus
Masking
Outcomes Assessor
Masking Description
oral lichen planus
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tacrolimus/corticosteroid
Arm Type
Experimental
Arm Description
topical steroids ( triamcinolone acetonide 0.1 %), tacrolimus paste and tacrolimus patch
Arm Title
corticosteroids
Arm Type
Active Comparator
Arm Description
topical corticosteroid
Arm Title
tacrolimus
Arm Type
Active Comparator
Arm Description
topical tacrolimus patch and tacrolimus paste
Intervention Type
Drug
Intervention Name(s)
Corticosteroid Topical
Other Intervention Name(s)
tacrolimus paste and patch topical
Intervention Description
topical tacrolimus and corticosteroids
Primary Outcome Measure Information:
Title
clinical score
Description
"0" represnted no lesion/normal mucosa, "1" mild white stria / no erythematous area
Time Frame
change from baseline at 12 weeks
Secondary Outcome Measure Information:
Title
caspase-3
Description
caspase-3 cells count in immunostained section
Time Frame
change from base line at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Noha Dawoud
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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