Skip to main content
Exit comparison
Removed
Added

Datasets Comparison

Versions selector

3
4
1234

Version 3

A novel narrow band ultraviolet B (NB-UVB) perilesional irradiation for treating vitiligo with complete leukotrichia: A 12-week, open-label, double-arm, multicenter, randomized clinical trial

Published:4 March 2024|Version 3|DOI:10.17632/754r78nmbm.3
Contributor:雪琛 曹

Description

Background: Vitiligo is a prevalent dermatological condition wherein the loss of melanocytes leads to skin depigmentation with or without leukotrichia. Existing phototherapies can be ineffective for treating vitiligo patients with complete leukotrichia. Our modified approach of ‘NB-UVB Perilesional Irradiation’ offers a new clinical alternative for treating vitiligo patients with complete leukotrichia. Objective: This study aimed to compare the efficacy of NB-UVB Perilesional irradiation with conventional NB-UVB therapy for repigmentation in vitiligo patients with complete leukotrichia. Methods: This is a 12-week, open-label, double-arm, multicenter clinical trial, with a total of 121 vitiligo patients included in the study protocol. All patients were required to have a patch of 100% white vellus hair on their body, with an area less than 1% of their body surface area. The subjects were randomly divided into two groups: one group received conventional NB-UVB irradiation (CI), while the other group received perilesional NB-UVB irradiation (PI). Both groups of patients received topical tacrolimus. The primary outcome was the mean percentage reduction in vitiligo area from baseline to week 12. Findings: A statistically significant difference in improvement from baseline was observed in the PI group compared to the CI group (-30·8%±11·8%, -25·5%±11·05%, p=0·01) (pair-wise comparison p=0·900 at week 4, p=0·104 at week 8, p=0·01 at week 12). After subgroup analysis, patients older than 18 years old (p=0·014), with lesions on their limbs and trunk (p=0·003), or with a disease duration less than four years (p=0·029), obtained a superior efficacy of repigmentation with PI compared to CI. Meanwhile, at week 12, the average percentage change from baseline of leukotrichia in the irradiation area significantly decreased from 100% to 82·2±13·65% in the PI group, and from 100% to 88·7±9·64% in the CI group (p=0·027). Additionally, the lesions exhibited enhanced marginal repigmentation in the PI group (45/62 [72·58%]) compared to the CI group (p=0·008). Adverse events were minor, including desquamation and dryness, erythema, and blisters. No severe or lasting side effects were observed during the study. Interpretation: PI has a better effect on the repigmentation of vitiligo with complete leukotrichia than CI and offers a valuable new therapeutic option for vitiligo patients with complete leukotrichia.

Steps to reproduce

Sample size calculation The primary outcome index was the proportion of vitiligo patients whose leukoplakia area was reduced by more than 10%, and the primary index P1=50% in the experimental group and P2=20 in the control group were expected. Using two sets of independent samples t-test, the class I error was controlled at 0·05 on both sides, when the power was 80% and 90%, the ratio of the two groups was 1:1, the shedding rate was 10%, and the power of 0·8, the sample size of each group was 40 cases, and the total sample size was 80 cases. At 0·9 power, the sample size of each group was 54 cases, and the total sample size was 108. Descriptive statistics meeting the criteria for normal distribution are reported as means (±standard deviation). Lesional areas were measured using Image J (V.1.8.0). Independent samples t-tests were employed to compare groups. Chi-square tests were utilized to compare frequencies and percentages for statistical representation and comparison between groups. Paired t-tests were employed to compare patients before and after treatment, whereas the Mann-Whitney U test was utilized to compare graded data prior to and following treatment. Multiple time points were analyzed using repeated measures ANOVA. Statistical significance was determined at a threshold of p < 0·05.

Institutions

Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital

Categories

Dermatology

Funding

National Natural Science Foundation of China

8227120662

National Natural Science Foundation of China

81872541

Licence

Creative Commons Attribution 4.0 International

Version 4

A novel narrow band ultraviolet B (NB-UVB)

Published:5 March 2024|Version 4|DOI:10.17632/754r78nmbm.4
Contributor:雪琛 曹

Description

Background:

Institutions

Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital

Categories

Dermatology

Licence

Creative Commons Attribution 4.0 International