Uses of Tacrolimus in Behcet Disease
Condition: Oral Ulcer; Behcet Syndrome
MeSH terms: Behcet Syndrome; Oral Ulcer
Study type: Interventional

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)
    

Intervention name(s): Tacrolimus ointment
Intervention type(s): Drug
Intervention description(s): oral gel
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment