Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02925767
Other study ID # VC16DISI0088
Secondary ID
Status Recruiting
Phase N/A
First received October 3, 2016
Last updated January 18, 2018
Start date August 2016
Est. completion date August 30, 2018

Study information

Verified date January 2018
Source The Catholic University of Korea
Contact Jung Min Bae, MD, PhD
Phone 82-31-249-8209
Email jminbae@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date August 30, 2018
Est. primary completion date January 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
311-nm Ti:Sapphire laser
Pallas, LaserOptek, South Korea
308-nm excimer laser
XTRAC, PhotoMedex, US

Locations

Country Name City State
Korea, Republic of St. Vincent's Hospital Suwon Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The adverse effects of both two laser treatments At 4 weeks, 8 weeks, and 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT05298033 - Study of Efficacy, Safety and Tolerability of Crisaborole and PF-07038124 With and Without NBUVB in Vitiligo Phase 2
Recruiting NCT05872477 - Promoting Repigmentation After Epidermal Cell Suspension Grafting and preVENTing the Loss of Melanocytes Using Topical Ruxolitinib for Vitiligo in Resistant Areas Phase 2
Terminated NCT04374435 - Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo N/A
Completed NCT04103060 - Safety and Tolerability Study of Cerdulatinib Gel, 0.37% in Adults With Vitiligo Phase 2
Terminated NCT04271501 - Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure for Repigmentation of Stable Vitiligo Lesions N/A
Completed NCT04530344 - Assess the Long Term Efficacy and Safety of Ruxolitinib Cream in Participants With Vitiligo Phase 3
Not yet recruiting NCT05008887 - Fractional CO2 Laser-assisted Cutaneous Delivery of Methotrexate Versus 5-fluorouracil in Stable Non-segmental Vitiligo Phase 4
Terminated NCT02191748 - Assessing the Efficacy of Needling With or Without Corticosteroids in the Repigmentation of Vitiligo Phase 2/Phase 3
Terminated NCT01262547 - A New Micrografting Technique for Vitiligo Phase 2
Completed NCT01382589 - Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Light in the Treatment of Nonsegmental Vitiligo Phase 2
Active, not recruiting NCT04971200 - Pilot Study Assessing the Effect of Tildrakizumab in Vitiligo Early Phase 1
Completed NCT04872257 - Oral Vitamin D Supplementation Combined With Phototherapy as a Treatment for Vitiligo N/A
Completed NCT04547998 - Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions N/A
Not yet recruiting NCT04039451 - Prevalence of Psoriasis and Vitiligo in Assiut Governorate, Egypt
Not yet recruiting NCT03611348 - Microneedling and Latanoprost in Acrofacial Vitiligo Phase 2/Phase 3
Recruiting NCT03199664 - Effectiveness of Narrow-band Ultraviolet B Combined With Topical Tacrolimus 0.03% in Treatment of Patients With Vitiligo Phase 4
Recruiting NCT03340155 - Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases N/A
Completed NCT03249064 - Response to Tregs in Innate Immunity Receptor LRP1 (CD91) and Tregs in Periferic Blood Mononuclear Cells in Patients With Non-segmentary Vitiligo N/A
Recruiting NCT05635266 - Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
Recruiting NCT04246372 - Tofacitinib for Immune Skin Conditions in Down Syndrome Phase 2