Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05032248 |
Other study ID # |
behcet |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 1, 2019 |
Est. completion date |
December 1, 2019 |
Study information
Verified date |
August 2021 |
Source |
Assiut University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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)
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)