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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)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05139667
Enrollment
30
Registered
2021-12-01
Start date
2019-05-20
Completion date
2021-10-20
Last updated
2021-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Lichen Planus

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.

Interventions

topical tacrolimus and corticosteroids

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

oral lichen planus

Intervention model description

treatment of oral lichen planus

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frameDescription
clinical scorechange from baseline at 12 weeks0 represnted no lesion/normal mucosa, 1 mild white stria / no erythematous area

Secondary

MeasureTime frameDescription
caspase-3change from base line at 8 weekscaspase-3 cells count in immunostained section

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026