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
About this trial
This is an interventional treatment trial for Oral Lichen Planus
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
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
NCT ID
NCT05139667
First Posted
November 18, 2021
Last Updated
November 18, 2021
Sponsor
Ain Shams University
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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