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

NCT ID: NCT05139667

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-20

Study Completion Date

2021-10-20

Brief Summary

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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

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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.

Conditions

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Oral Lichen Planus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

treatment of oral lichen planus
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
oral lichen planus

Study Groups

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tacrolimus/corticosteroid

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

Group Type EXPERIMENTAL

Corticosteroid Topical

Intervention Type DRUG

topical tacrolimus and corticosteroids

corticosteroids

topical corticosteroid

Group Type ACTIVE_COMPARATOR

Corticosteroid Topical

Intervention Type DRUG

topical tacrolimus and corticosteroids

tacrolimus

topical tacrolimus patch and tacrolimus paste

Group Type ACTIVE_COMPARATOR

Corticosteroid Topical

Intervention Type DRUG

topical tacrolimus and corticosteroids

Interventions

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Corticosteroid Topical

topical tacrolimus and corticosteroids

Intervention Type DRUG

Other Intervention Names

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tacrolimus paste and patch topical

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Noha Dawoud

assistant lecturer of oral medicine and diagnosis

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Noha Dawoud

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Ibrahim SS, Ragy NI, Nagy NA, El-Kammar H, Elbakry AM, Ezzatt OM. Evaluation of muco-adhesive tacrolimus patch on caspase-3 induced apoptosis in oral lichen planus: a randomized clinical trial. BMC Oral Health. 2023 Feb 14;23(1):99. doi: 10.1186/s12903-023-02803-8.

Reference Type DERIVED
PMID: 36788511 (View on PubMed)

Other Identifiers

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FDASU-RECD123

Identifier Type: -

Identifier Source: org_study_id