Uses of Tacrolimus in Behcet Disease

NCT ID: NCT05032248

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2019-12-01

Brief Summary

Background: oral ulceration is the earliest and commonest manifestation of Behcet's disease (BD). Minor aphthous like ulcers (<10 mm in diameter) are the most common type (85%); major or herpetiform ulcers are less frequent. It is occurred about in Egypt; 3.6/100,000 % and high recurrence rate with traditional treatment. Colchicine is the first line of treatment in mucocutaneous manifestation of BD through its anti-inflammatory effect. Tacrolimus oral gel is safe and effective in treating aphthous ulcers in many diseases. Objectives: to compare the clinical efficacy of topical tacrolimus versus oral colchicine upon disease activity, pain and ulcer severity in oral ulcer associated with BD. Study design: A randomized double -blinded trial.

Setting: Rheumatology clinic, Assiut University Hospital and Faculty of Dental Medicine, AlAzhar University, Assiut branch outpatient's clinic. Methods: 40 BD participants (> 3 months taken traditional treatment with persistent active oral ulceration). They have been equally randomized into either group I (Colchicine and topically applied Tacrolimus), or group II (Colchicine only). Measurements: Behcet's Disease Current Activity Form (BDCAF), Ulcer Severity Score (USS) and visual analog scale (VAS) pre-injection, then re-evaluated postinjection at four-time points (15 days, 1st, 2nd and 3rd months) and Determination of Natural Killer (NK) cells number in salival wash before treatment (at base line) and after the treatment (after 3 months)

Detailed Description

Background: oral ulceration is the earliest and commonest manifestation of Behcet's disease (BD). Minor aphthous like ulcers (<10 mm in diameter) are the most common type (85%); major or herpetiform ulcers are less frequent. It is occurred about in Egypt; 3.6/100,000 % and high recurrence rate with traditional treatment. Colchicine is the first line of treatment in mucocutaneous manifestation of BD through its anti-inflammatory effect. Tacrolimus oral gel is safe and effective in treating aphthous ulcers in many diseases. Objectives: to compare the clinical efficacy of topical tacrolimus versus oral colchicine upon disease activity, pain and ulcer severity in oral ulcer associated with BD. Study design: A randomized double -blinded trial.

Setting: Rheumatology clinic, Assiut University Hospital and Faculty of Dental Medicine, AlAzhar University, Assiut branch outpatient's clinic. Methods: 40 BD participants (> 3 months taken traditional treatment with persistent active oral ulceration). They have been equally randomized into either group I (Colchicine and topically applied Tacrolimus), or group II (Colchicine only). Measurements: Behcet's Disease Current Activity Form (BDCAF), Ulcer Severity Score (USS) and visual analog scale (VAS) pre-injection, then re-evaluated postinjection at four-time points (15 days, 1st, 2nd and 3rd months) and Determination of Natural Killer (NK) cells number in salival wash before treatment (at base line) and after the treatment (after 3 months)

Conditions

Oral Ulcer; Behcet Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

tacrolimus

group I (Colchicine and topically applied Tacrolimus),

Group Type: EXPERIMENTAL

Tacrolimus ointment

Intervention Type: DRUG

oral gel

placebo

group II (Colchicine and topically applied Placebo),

Group Type: PLACEBO_COMPARATOR

Tacrolimus ointment

Intervention Type: DRUG

oral gel

Interventions

Tacrolimus ointment

oral gel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• active oral ulcers for Behcet's Disease

Exclusion Criteria

• patients who received biological therapy comorbid systemic diseases allergy to Tarcolimus drug.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Manal Hassanien

assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut governorate

Asyut, , Egypt

Countries

Egypt

Other Identifiers

behcet

Identifier Type: -

Identifier Source: org_study_id