Erythema dose

Minimal erythema dose (MED) for subject, UVB dose per
session per cm2, total dose of UVB received by affected subjects
and percentage of repigmentation after active and placebo
treatments (controls). *Cumulative dose = Session dose * n° of
sessions



Photographs of the subjects were taken at the beginning of the
therapy and then once a month for six months using Wood’s lamp. One
month after the treatment was finished, the results were evaluated
by planimetry based on two comparable photographs.

*Results.*

The MED of lesional skin was between 200 and 500 mJ/cm^2 . In
general repigmentation started 1 month after the beginning of the
UV-B microphoto-therapy.

After 5 months 5 subjects responded with more than 75%
repigmentation (3 achieved 100% repigmentation), 2 individuals
showed 50-75% repigmentation and one showed repigmentation in less
then 50% of the area treated.

No adverse effects were noted. The compliance was excellent. No pain
or burning or itching sensations were reported by the subjects.
Vitiligo was not aggravated in any subject. The average cumulative
UV-B dose with the treatment was 5.025 J/cm^2 (range 2.4-6 J/cm^2 )
per subject.

*Comments.*

According to the principles of evidence-based medicine,
meta-analysis of all relevant studies in the literature recently
showed that the highest mean success rates in repigmentation of
vitiligo were achieved with narrow band UV-B, followed by broadband
UV-B and oral methoxsalen plus UV-A therapy (2). The same study
showed that oral methoxsalen plus UV-A was associated with the
highest rates of side effects, while no side effects were reported
with UV-B therapy (2). Thus, following the recommendations of Njoo
et al based on the meta-analysis of the literature, it seems that
when patients exhibit generalized vitiligo, UV-B (narrow band or
broad band) therapy or, as a second choice, oral methoxsalen plus
UV-A, should be recommended. For patients with localized vitiligo
(defined as vitiligo affecting less than 20% of the total body
surface) (2) a class 3 corticosteroid is advised as first choice
therapy (2).

On the basis of the present study carried out with a novel device
allowing limited and focused UV-B photoradiation, we suggest that
UV-B therapy limited only to the vitiligo patches could be
considered the first-choice therapy for patients with localized
vitiligo, although more studies will be necessary to confirm the
good results and establish the entity of possible long-term side
effects. The protocol for the use of focused UV-B therapy here
presented show that the therapy need not be continuous and that the
cumulative UV-B doses received by the single patient with the
BIOSKIN^® device is obviously much lower than the cumulative UV-B
dose received by the previously established UV-B treatment intended
to treat the whole, or at least a considerable part, skin surface
independent of the percentage of affected skin. It is implicit that
therapy limited to the vitiligo patches carries substantially less
risk for skin cancer that any other kind of systemic photoradiation,
with or without oral intake of psoralen.