Randomized, Split-body, Single-blinded Clinical Trial of NB-UVB Treatment for Vitiligo
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|ClinicalTrials.gov Identifier: NCT02506101|
Recruitment Status : Terminated (Lack of enrollment and staff availability to administer treatment.)
First Posted : July 22, 2015
Results First Posted : December 11, 2017
Last Update Posted : April 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Vitiligo Pigmentation Dyschromia||Device: narrow-band ultraviolet B phototherapy||Not Applicable|
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:
- 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.
- 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 (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized, Split-Body, Single-Blinded Clinical Trial of Narrow Band-Ultraviolet B (NB-UVB) Treatment for Vitiligo|
|Actual Study Start Date :||July 2015|
|Actual Primary Completion Date :||October 4, 2016|
|Actual Study Completion Date :||October 4, 2016|
Experimental: narrow-band ultraviolet B phototherapy
We will use the 3 Series PC & SP Phototherapy Cabinet for treatment of vitiligo.
Device: narrow-band ultraviolet B phototherapy
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.
No Intervention: no intervention
- Vitiligo Area Scoring Index (VASI) [ Time Frame: 24 weeks ]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].
- Dermatology Life Quality Index (DLQI) [ Time Frame: 24 weeks ]Quality of life assessment
- Skindex-29 Questionnaire [ Time Frame: 24 weeks ]Quality of life assessment
- Response Stability Index [ Time Frame: 24 weeks ]
- Number of Participants With Histological Change in Tissue Samples [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02506101
|United States, Maryland|
|Johns Hopkins Dept. of Dermatology|
|Baltimore, Maryland, United States, 21287|
|Principal Investigator:||Ginette Okoye, MD||Johns Hopkins School of Medicine|