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A randomized controlled non-inferiority trial based on split-body was planned to compare the efficacy of 308-nm excimer laser and 311-nm Ti:Sapphire laser in patients with vitiligo.
The 308-nm excimer laser (EL) has been widely used for localized vitiligo. Recently, the 311-nm Ti:Sapphire laser (TSL) was developed to treat patients with vitiligo. To compare the efficacy of TSL vs. EL in the treatment of vitiligo.
A randomized controlled non-inferiority trial based on split-body was planned. The paired symmetric vitiliginous lesions will be randomized to either TSL or EL treatment groups. All lesions will be treated twice weekly for a total of 12-week period. The degree of repigmentation will be assessed as % from baseline by using a computer program every 4 weeks, and the non-inferiority margin was set at 10%. Overall 16 patients will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The 311-nm Ti:Sapphire laser treatment group | Experimental | All lesions were treated twice weekly for a total of 12-week period. |
|
| The 308-nm excimer laser treatment group | Active Comparator | All lesions were treated twice weekly for a total of 12-week period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 311-nm Ti:Sapphire laser | Device | Pallas, LaserOptek, South Korea |
|
| 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 of both two laser treatments | At 4 weeks, 8 weeks, and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung Min Bae, MD, PhD | Contact | 82-31-249-8209 | 8209 | jminbae@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital | Recruiting | Suwon | Gyeonggi-do | 16247 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30681166 | Derived | Bae JM, Eun SH, Lee HN, Kim GM, Grimes PE, Lee JH. Comparison of 311-nm Titanium:Sapphire laser and 308-nm excimer laser treatment for vitiligo: A randomized controlled non-inferiority trial. Lasers Surg Med. 2019 Mar;51(3):239-244. doi: 10.1002/lsm.23048. Epub 2019 Jan 25. |
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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 |
|---|---|
| D054018 | Lasers, Excimer |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| 308-nm excimer laser | Device | XTRAC, PhotoMedex, US |
|