Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo
NCT ID: NCT03365141
Last Updated: 2017-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2017-11-14
2018-09-15
Brief Summary
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Detailed Description
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The investigators will perform a randomized split-body pilot trial to test the exact efficacy of intralesional triamcinolone injections. The paired symmetric vitiliginous lesions will be randomized to either control or injection groups. All lesions will be treated with narrowband UV-B phototerapy or excimer laser weekly and twice daily application of topical tacrolimus ointment for a total of 12-week period. Intralesional injections of 0.4mg/cc triamcinolone once a week are given to the experimental group. The degree of repigmentation will be assessed as % from baseline.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental group
All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period.
Intervention: Intralesional injection of triamcinolone acetonide (0.4mg/cc) will be performed weekly.
Triamcinolone acetonide 0.4mg/cc
* Intralesional injection of dilute triamcinolone acetonide with 2% lidocaine (400mg/20 mL) would be performed to reduce pain when injecting the drug.
* Once weekly, for a total of 12 weeks
Phototherapy (NBUVB or excimer laser)
NBUVB or excimer laser treatment weekly
Topical tacrolimus
Application of topical tacrolimus ointment twice a day
Control group
All lesions will treated with NBUVB or excimer laser weekly and application of topical tacrolimus ointment twice daily for a total of 12-week period.
Phototherapy (NBUVB or excimer laser)
NBUVB or excimer laser treatment weekly
Topical tacrolimus
Application of topical tacrolimus ointment twice a day
Interventions
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Triamcinolone acetonide 0.4mg/cc
* Intralesional injection of dilute triamcinolone acetonide with 2% lidocaine (400mg/20 mL) would be performed to reduce pain when injecting the drug.
* Once weekly, for a total of 12 weeks
Phototherapy (NBUVB or excimer laser)
NBUVB or excimer laser treatment weekly
Topical tacrolimus
Application of topical tacrolimus ointment twice a day
Eligibility Criteria
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Inclusion Criteria
2. A patient who voluntarily agreed to participate in the study by listening to the explanation of the purpose and method of the study
3. A patient who has bilateral two or more vitiligo lesions with similar degree of progression in the face or trunk
4. A patient who has no further response to excimer laser or short wavelength ultraviolet B therapy, which is a conventional treatment for vitiligo
Exclusion Criteria
2. Patients with enlarged or spreading lesions of vitiligo
3. Patients who do not want to do so or who refuse to write a consent form
4. Patients who are inadequate for triamcinolone acetonide administration (pregnant women, infectious and systemic fungal infections without effective antimicrobial agents, immunosuppression, hypersensitivity reactions to and concomitant use of triamcinolone or its components, spontaneous thrombocytopenia, purpura, herpes simplex, shingles, chicken pox patients)
5. Others those who are deemed unsuitable for the examination at the discretion of the examiner
19 Years
ALL
No
Sponsors
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The Catholic University of Korea
OTHER
Responsible Party
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Jung Min Bae
Assistant Professor
Locations
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St. Vincent's Hospital
Suwon, Gyonggi-do, South Korea
Countries
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Facility Contacts
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Jung Min Bae, MD, PhD
Role: primary
Other Identifiers
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VC17MESI0190
Identifier Type: -
Identifier Source: org_study_id