Patients

Thirty-five patients (16 men, 19 female), aged from one to sixty-two years (mean age, 22.7 years) were enrolled in this study (Table 1). Twenty-nine pa­tients were affected by focal type vitiligo and six presented with segmental vitiligo. Fifty-three patches of vitiligo in thirty-five patients were treated with the device. All patients showed cutaneous involve­ment of < 10% of total body area. Four of the thirty-five patients had skin photo type III, twenty- eight skin type IV, and the remaining three patients skin type V. Twenty-five patients had no history of previous treatment and the other ten patients had been treated previously using other methods. Subjects with previous treatment were enrolled after a wash­out period of two weeks for topical steroids, four weeks for any form of phototherapy, and eight weeks for PUVA or immunomodulating agents. Patients with a history of skin cancer, photosensi- tivity or a photo-mediated disorder, radiotherapy, or immunosuppressive treatments were excluded, as were pregnant or breast-feeding women.

Irradiation source

Dua-lightTM (TheraLight Inc., Carlsbad, Cali­fornia) is a high-pressure mercury lamp capable of emitting either UVB or UVA. UVB with a spectral output peaking between 302 and 312 nm and an average weighted erythemal wavelength of 304 nm
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Table 1. Characteristics of the study population

Number of patients

35

Number of patches of vitiligo

53

Age [mean (range)]

22.7 (1-62)

Gender

Male

16

Female

19

Fitzpatrick skin type

III

4

IV

28

V

3

Type of vitiligo [patients (patches)]

Focal

29 (47)

Segmental

6 (6)

Interventions

Treatments were directed at targeted lesions with only a slight overlap of normal surrounding skin. Starting UV doses were 70% of the predetermined minimal erythema dose (MED). MED determinations were performed on vitiligo lesions.

Vitiliginous patches were treated twice a week for a maximum of sixty treatment sessions. UV doses were increased by 10% if no erythema or discomfort occurred, and was applied at a constant level for subsequent sessions when a patient reported very mild erythema or itching. When severe erythema with pain, burning, or blistering was reported, treatment was withheld and after resolution the irradiation dose was decreased by 20%.
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Assessments

Complete patient histories were documented and skin examinations were performed at initial visits. Photographic records were maintained throughout the study from the first visit, throughout therapy, to final follow-up. Improvements (re-pigmentation; defined as percentage reductions in involved skin areas) versus baseline examinations were measured quantitatively using a visual scale by two indepen­dent investigators and graded as follows: Grade 0 <less than 1% improvement, Grade 1<1% to 25% improvement, Grade 2=26% to 50% improvement, Grade 3=51% to 75% improvement, Grade 4^75% improvement.

Statistical analysis

Results were analyzed using a statistical package (SAS system for Windows V.9.13, SAS Institute Inc, Cary, NC). The Wilcoxon-Rank Sum test was used to determine the effects of variables, such as, type of vitiligo, site, or prior treatment history on final outcome. Fisher’s exact test was to determine the effects of variables, such as, clinical site and the presence of side effects on final outcome. The Cochran-Mantel-Haenszel test was used to analyze the relation between skin photo type and final outcome, and Spearmen’s Rank Correlation was used to identify the presence of interactions between final outcome and variables, such as, cumulative dose or number of treatment sessions. Statistical significance was defined by a p value of less than 0.05.
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