Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo

Study Overview
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Brief Summary
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A randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo

Detailed Description
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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.

Official Title
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Efficacy of Intralesional Triamcinolone Injection in the Treatment of Vitiligo

Conditions
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Vitiligo, Treatment, Intralesional Injection, Corticosteroid

Intervention / Treatment
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* Drug: Triamcinolone acetonide 0.4mg/cc
* Device: Phototherapy (NBUVB or excimer laser)
* Drug: Topical tacrolimus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age : 19 or older A patient who voluntarily agreed to participate in the study by listening to the explanation of the purpose and method of the study A patient who has bilateral two or more vitiligo lesions with similar degree of progression in the face or trunk 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: Patients under the age of 19 Patients with enlarged or spreading lesions of vitiligo Patients who do not want to do so or who refuse to write a consent form 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) Others those who are deemed unsuitable for the examination at the discretion of the examiner

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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. | Drug: Triamcinolone acetonide 0.4mg/cc<br>* 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<br>Device: Phototherapy (NBUVB or excimer laser)<br>* NBUVB or excimer laser treatment weekly<br>Drug: Topical tacrolimus<br>* Application of topical tacrolimus ointment twice a day<br>|
| Active Comparator: Control group<br>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. | Device: Phototherapy (NBUVB or excimer laser)<br>* NBUVB or excimer laser treatment weekly<br>Drug: Topical tacrolimus<br>* Application of topical tacrolimus ointment twice a day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The repigmentation rate (change from baseline) of the vitiliginous patch | The degree of repigmentation will be assessed as % from baseline by using a computer program. | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adverse effects |  | every weeks up to 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitiligo, intralesional injection, corticosteroid, triamcinolone