Vitiligo Clinical Trial
Official title:
Comparison of Cyclic On-off and Continuous Excimer Laser Treatment for Vitiligo: A Randomized Controlled Non-inferiority Trial
Verified date | February 2017 |
Source | Ajou University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
OBJECTIVE: To investigate the efficacy of the cyclic on-off treatment compared to the
conventional continuous excimer laser treatment.
DESIGN: A randomized, controlled, split-body, non-inferiority study. SETTING: The trial was
performed in two tertiary health care centers in Korea.
PARTICIPANT: Twelve patients (16 pairs of lesions) with stable symmetric vitiligo less than
5 years' disease duration were enrolled.
INTERVENSION: The paired symmetric vitiliginous lesions were randomized to either the
continuous or the cyclic on-off treatment. All lesions were treated twice weekly for
9-month: continuously, or cyclically with 2-month treatment and 1-month intermission (total
3 cycles). Topical tacrolimus was applied throughout the trial.
OUTCOME MEASURES: The repigmentation was assessed using an image analysis program with
clinical photographs. The primary outcome was mean difference of repigmentation rates and
the non-inferiority margin was set at 10%. During intermission period, the clinical changes
such as loss of repigmentation or worsening of the vitiligo lesions were assessed.
Status | Completed |
Enrollment | 12 |
Est. completion date | December 31, 2016 |
Est. primary completion date | December 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years and older |
Eligibility |
Inclusion Criteria: - Patients with symmetric vitiligo - Patients with less than 5 years' disease duration Exclusion Criteria: - The patients taking systemic steroids - The patients with currently enlarging lesions - The patients who cannot follow the treatment schedule |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Ajou university hospital | Suwon-si | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Ajou University School of Medicine |
Korea, Republic of,
Aberdam E, Roméro C, Ortonne JP. Repeated UVB irradiations do not have the same potential to promote stimulation of melanogenesis in cultured normal human melanocytes. J Cell Sci. 1993 Dec;106 ( Pt 4):1015-22. — View Citation
Hofer A, Hassan AS, Legat FJ, Kerl H, Wolf P. Optimal weekly frequency of 308-nm excimer laser treatment in vitiligo patients. Br J Dermatol. 2005 May;152(5):981-5. — View Citation
Park KK, Liao W, Murase JE. A review of monochromatic excimer light in vitiligo. Br J Dermatol. 2012 Sep;167(3):468-78. doi: 10.1111/j.1365-2133.2012.11008.x. Review. — View Citation
Zhang XY, He YL, Dong J, Xu JZ, Wang J. Clinical efficacy of a 308 nm excimer laser in the treatment of vitiligo. Photodermatol Photoimmunol Photomed. 2010 Jun;26(3):138-42. doi: 10.1111/j.1600-0781.2010.00509.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean difference of quantitative changes in repigmented area between continuous and cyclic on-off treatment. | The degree of repigmentation was assessed with a repigmentation rate (%) with clinical photographs by using an image analysis program (Digital Researcher for Vitiligo Area Evaluation, Dr. VAE, Korea). | Through study completion, an average of 9 months |
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