Vitiligo, Treatment, Intralesional Injection, Corticosteroid
Conditions
Keywords
vitiligo, intralesional injection, corticosteroid, triamcinolone
Brief summary
A randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo
Detailed description
Intralesional corticosteroid injections have been a long-standing treatment for refractory vitiligo, with some patients showing significant improvement without surgical intervention. 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.
Interventions
DRUGTriamcinolone 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
DEVICEPhototherapy (NBUVB or excimer laser)
NBUVB or excimer laser treatment weekly
Application of topical tacrolimus ointment twice a day
Sponsors
The Catholic University of Korea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age : 19 or older 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
1. Patients under the age of 19 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The repigmentation rate (change from baseline) of the vitiliginous patch | Baseline and 12 weeks | The degree of repigmentation will be assessed as % from baseline by using a computer program. |
Secondary
| Measure | Time frame |
|---|---|
| The adverse effects | every weeks up to 13 weeks |
Countries
South Korea
Outcome results
None listed