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)