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A randomized split-body pilot study was planned to confirm efficacy of intralesiona triamcinolone injection in patients with vitiligo
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | 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. |
|
| Control group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triamcinolone acetonide 0.4mg/cc | Drug |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The adverse effects | every weeks up to 13 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Recruiting | Suwon | Gyonggi-do | 16247 | South Korea |
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| ID | Term |
|---|---|
| D014820 | Vitiligo |
| ID | Term |
|---|---|
| D017496 | Hypopigmentation |
| D010859 | Pigmentation Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D010789 | Phototherapy |
| D054018 | Lasers, Excimer |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D014221 | Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Phototherapy (NBUVB or excimer laser) | Device | NBUVB or excimer laser treatment weekly |
|
| Topical tacrolimus | Drug | Application of topical tacrolimus ointment twice a day |
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D013812 | Therapeutics |
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |