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

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT05139667
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
29
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Corticosteroid Topical
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
treatment of oral lichen planustreatment of oral lichen planus
Masking:
Single (Outcomes Assessor)
Masking Description:
oral lichen planus
Primary Purpose:
Treatment
Official Title:
Evaluation of Mucoadhesive Tacrolimus Patch on Caspase-3 Inducing Apoptosis in Oral Lichen Planus ( A Randomized Controlled Clinical Trial With Immunohistochemical Analysis)
Actual Study Start Date :
May 20, 2019
Actual Primary Completion Date :
Oct 20, 2021
Actual Study Completion Date :
Oct 20, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. clinical score [change from baseline at 12 weeks]

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

    Secondary Outcome Measures

    1. caspase-3 [change from base line at 8 weeks]

      caspase-3 cells count in immunostained section

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Noha Dawoud Cairo Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Noha Dawoud, assistant lecturer of oral medicine and diagnosis, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05139667
    Other Study ID Numbers:
    • FDASU-RECD123
    First Posted:
    Dec 1, 2021
    Last Update Posted:
    Dec 1, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lichen Planus, Oral
    Lichen Planus
    Tacrolimus

    Study Results

    No Results Posted as of Dec 1, 2021