A study by Tanew et al,18 also evaluated the effect of oral PLE in
PMLE. Of the 35 patients studied, 30 developed PMLE lesions
after irradiation with UVA and 18 after UVB irradiation. After
two-week treatment with oral weight-based dosing of daily PLE
(≤55kg: 720mg/day; 56-70kg: 960mg/day; >70kg: 1200mg/day),
9(30%) patients and 5(28%) patients were unresponsive to repeated
UVA and UVB exposure, respectively. The mean number
of exposures required to induce PMLE lesions in remaining patients
showed a statistically significant increase for both UVA
(P=.005) and UVB (P=.047), demonstrating the suppressive effect
of oral PLE on photoinduction of PMLE.
Oral PLE has been reported as an adjuvant therapy in SCLE. A
recent publication reported a patient with biopsy-proven SCLE,
moderately controlled on hydroxychloroquine sulfate 200mg
BID and daily use of zinc oxide sunscreen; this patient achieved
near total remission of his SCLE with addition of oral PLE 240
mg daily.19 Within four months, the patient demonstrated clinical
improvement on the face and neck as well as complete clearance
of the skin on his back, and in 37 months of daily oral PLE use, he
only had 3 flares, which were all in the summer months. Clearly,
more studies are needed to confirm this finding.
PLE and Melasma
The ability of PLE to provide systemic photoprotection has lead
to the study of PLE as an adjunctive treatment of melasma (Table
1). A study presented as a poster (but yet unpublished) by
Martin et al,20 reported that oral PLE is an effective and well-tolerated
agent in reducing melasma severity. In this double-blind
placebo controlled trial, 21 females were randomized to receive
either placebo plus sunscreen with SPF 45 or oral PLE plus sunscreen
with SPF 45 for 12 weeks, and participants rated their
perceived improvement at the end of 12 weeks. The authors
found a statistically significant improved mean Melasma Area
and Severity Index (MASI) scores in the oral PLE group. Additionally,
photographic assessment by a blinded investigator
revealed mild improvement in 43% of subjects receiving PLE
as compared to 17% of patients receiving placebo, and marked
improvement in 14% of subjects receiving PLE as compared to
0% of patients receiving placebo.
A recently published randomized, double-blinded study by
Ahmed et al,21 found no difference in improvement of melasma
in patients taking oral PLE versus placebo. In this study, forty
Hispanic females were randomized to receive either placebo
or oral PLE 240 mg three times daily for 12 weeks, in addition
to a “standard topical sunscreenâ€. Treatment outcomes were
measured by determining melanin intensity via reflectance
spectrophotometry of affected as well as adjacent normal skin,
and MASI scores. Although the authors found a statistically significant
improvement from baseline to week 12 in both PLE and
the placebo group, there was no significant difference between
the two groups using either outcome measure. They concluded that oral PLE was no better than placebo as an adjunct to topical
sunscreen for the treatment of melasma.
Given limited data on treatment of melasma with oral PLE,
more studies with a larger sample size are needed to further
evaluate the efficacy of oral PLE for the treatment of melasma.
PLE and Vitiligo
Oral PLE has also been studied as a treatment for repigmentation
in vitiligo. PLE’s antioxidant effects as well as a shift from a
Th1 T-cell cytokine profile to a Th2 T-cell cytokine profile—namely
a decreased production of IL-2, IFN-γ and TNF-α and increased
production of anti-inflammatory cytokine, IL-10 - are thought to
play a role in its use in vitiligo.7 A poster presentation by Pacifico
et al,22 at the American Academy of Dermatology meeting in
2009 suggests that oral PLE 480 mg daily in combination with
NB-UVB was more effective in repigmentation of patients with
generalized vitiligo than treatment with twice weekly NB-UVB
alone (40% vs 22%, P<0.0005). The authors concluded that oral
PLE in conjunction with NB-UVB can improve response to treatment
both in terms of extent and rapidity of repigmentation.
Another study by Reyes et al,23 compares PUVA alone to PUVA
plus oral PLE as a treatment for generalized vitiligo. In this
randomized, double-blinded clinical trial, nineteen patients underwent
randomization to receive either PUVA alone or PUVA
with oral PLE, and repigmentation rates were assessed by independent
dermatologists. The authors found a higher rate of
moderate to excellent repigmentation in the PUVA and oral PLE
group compared to the PUVA alone group. They also demonstrated
that oral PLE+PUVA normalizes expression of activation
markers by T cells and suppresses proliferation of peripheral
blood mononuclear cells versus PUVA alone. This study underscores
the immunomodulatory effects of oral PLE as an
adjuvant to phototherapy in treatment of vitiligo.
Another study by Middlekamp et al,24 investigated the effect
of oral PLE and NB-UVB in repigmentation in patients with
vitiligo. Fifty patients were randomized to receive either PLE
250mg orally TID or placebo, both in conjunction with NB-UVB
treatments twice weekly for 25-26 weeks, with the primary outcome
measure being percentage of repigmentation at week 26.
Although they did not find a statistically significant difference,
they observed higher repigmentation rates in PLE group, specifically
in the head and neck areas (44% vs 27%, P=0.06). They
also found that lighter skin types (Fitzpatrick skin types II and III)
showed significant increased repigmentation in the head and
neck areas compared to placebo group (47% vs 21%, P=0.01).
Secondary outcome measures included quality of life changes
measured with Skindex 29; there were no significant differences
between the PLE group and placebo group. Moreover,
patient self-assessment at week 26 indicated no differences between
PLE group and placebo group.