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

NCT05139667 | Completed Phase 4 DMC

• 1 other identifier: FDASU-RECD123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Lichen Planus

Outcome Measures

Primary Outcomes (1)

• clinical score

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

  change from baseline at 12 weeks

Secondary Outcomes (1)

• caspase-3

  change from base line at 8 weeks

Study Arms (3)

tacrolimus/corticosteroid

EXPERIMENTAL

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

Drug: Corticosteroid Topical

corticosteroids

ACTIVE COMPARATOR

topical corticosteroid

Drug: Corticosteroid Topical

tacrolimus

ACTIVE COMPARATOR

topical tacrolimus patch and tacrolimus paste

Drug: Corticosteroid Topical

Interventions

Corticosteroid Topical DRUG

topical tacrolimus and corticosteroids

Also known as: tacrolimus paste and patch topical

corticosteroids; tacrolimus; tacrolimus/corticosteroid

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• clinically and histologically proven painful bullous/erosive or atrophic forms of OLP

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Noha Dawoud

Cairo, Egypt

Location

Related Publications (1)

• 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.

  PMID: 36788511 DERIVED

MeSH Terms

Conditions

Lichen Planus, Oral

Interventions

Adrenal Cortex Hormones; Transdermal Patch

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Lichen Planus; Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: oral lichen planus
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of oral medicine and diagnosis

Model Details: treatment of oral lichen planus

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 1, 2021
• Study Start: May 20, 2019
• Primary Completion: October 20, 2021
• Study Completion: October 20, 2021
• Last Updated: December 1, 2021

Record last verified: 2021-11

Locations

EG (1)