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Uses of Tacrolimus in Behcet Disease

Primary Purpose

Oral Ulcer, Behcet Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Tacrolimus ointment
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Ulcer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • active oral ulcers for Behcet's Disease

Exclusion Criteria:

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

Sites / Locations

  • Assiut governorate

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

tacrolimus

placebo

Arm Description

group I (Colchicine and topically applied Tacrolimus),

group II (Colchicine and topically applied Placebo),

Outcomes

Primary Outcome Measures

Ulcer Severity Score (USS)
Ulcer Severity Score (USS)

Secondary Outcome Measures

Full Information

First Posted
August 27, 2021
Last Updated
August 27, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05032248
Brief Title
Uses of Tacrolimus in Behcet Disease
Official Title
Uses of Tacrolimus in Treatment of Oral Ulcers in Behcet Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Ulcer, Behcet Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tacrolimus
Arm Type
Experimental
Arm Description
group I (Colchicine and topically applied Tacrolimus),
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
group II (Colchicine and topically applied Placebo),
Intervention Type
Drug
Intervention Name(s)
Tacrolimus ointment
Intervention Description
oral gel
Primary Outcome Measure Information:
Title
Ulcer Severity Score (USS)
Description
Ulcer Severity Score (USS)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Assiut governorate
City
Assiut
Country
Egypt

12. IPD Sharing Statement

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Uses of Tacrolimus in Behcet Disease

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