The objective of this study is to assess the effectiveness and safety of narrowband-ultraviolet B (NB-UVB) treatment in adult subjects with vitiligo.
Vitiligo is a chronic acquired cutaneous disease of pigmentation that affects patients' quality of life across all degrees of involvement and severity. Phototherapy is a clinically indicated treatment for skin lesions. Treatments are usually administered in an outpatient setting, typically three times per week. This is a proof-of-concept study as there are few well-designed prospective clinical studies showing the efficacy of NB-UVB phototherapy in the treatment of vitiligo in terms of repigmentation and quality of life. The following are the proposed objectives of this study: 1. NB-UVB phototherapy improves vitiligo with at least 50% repigmentation compared to no treatment on affected areas of the trunk and extremities over 24 weeks. 2. NB-UVB phototherapy leads to improvement in quality of life as measured by standardized quality of life metrics (DLQI and Skindex-29) over 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
2
There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week.
Johns Hopkins Dept. of Dermatology
Baltimore, Maryland, United States
Vitiligo Area Scoring Index (VASI)
VASI scores of treated versus untreated symmetrical body sites.The percentage of vitiligo involvement is calculated in terms of hand units. One hand unit is approximately equivalent to 1% of the total body surface area. The degree of pigmentation is estimated to the nearest of one of the following percentages: 100% - complete depigmentation, no pigment is present; 90% - specks of pigment present; 75% - depigmented area exceeds the pigmented area; 50% - pigmented and depigmented areas are equal; 25% - pigmented area exceeds depigmented area; and 10% - only specks of depigmentation present. The VASI for each body region is determined by the product of the area of vitiligo in hand units and the extent of depigmentation within each hand unit measured patch. Total body VASI = S All body sites \[Hand Units\] ´ \[Residual depigmentation\].
Time frame: 24 weeks
Dermatology Life Quality Index (DLQI)
Quality of life assessment
Time frame: 24 weeks
Skindex-29 Questionnaire
Quality of life assessment
Time frame: 24 weeks
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