Vitiligo
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICE308-nm excimer laser
XTRAC, PhotoMedex, US
DEVICE311-nm Ti:Sapphire laser
Pallas, LaserOptek, South Korea
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
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age: older than 19 * A patient with stable non-segmental vitiligo * A patient with symmetrical vitiligo lesions * A patient with the willingness to comply with the study protocol during the study period and capable of complying with it * A patient who signed the informed consent prior to the participation of the study and who understands that he/she has a right to withdrawal from participation in the study at any time without any disadvantages
Exclusion criteria
* Age: lower than 20 * A pregnant or lactating patient * A patient with active or spreading vitiligo * A patient who cannot understand the study or who does not sign the informed consent
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 of both two laser treatments | At 4 weeks, 8 weeks, and 12 weeks |
Countries
South Korea
Contacts
Primary ContactJung Min Bae, MD, PhD
Outcome results
None listed