Patients with melanoma considered at high risk for recurrence or regional metastases often have to choose between adjuvant
interferon therapy or enrolling in a clinical trial. High-dose interleukin-2 therapy has had limited success in producing
durable responses in stage IV melanoma; this success has been offset by marked toxicity. High-dose interferon alpha
therapy has consistently shown disease-free survival benefit in clinical trials but has marked toxicity. The overall survival
benefit has been inconsistent and controversial. Treatment with granulocyte macrophage colony-stimulating factor has
shown promise in early studies. Various cytokines have had some success in treating advanced stage melanoma but with
marked toxicity. Cytokine therapy that is well-tolerated and consistently provides an overall survival benefit for highrisk
melanoma patients has not been achieved. Cytokines will continue to have a role in therapy for advanced-stage
melanoma, most likely in combination with other immunomodulatory therapy. The challenge is finding the right doses,
frequency, combinations, and duration of treatment.
Antonio Rusciani MD, Giuseppe Curinga MD, Giulio Menichini MD, Carmine Alfano MD, Luigi Rusciani MD
Background: Improvement in skin laxity can be difficult to achieve without invasive surgical procedures. Monopolar radiofrequency
(RF) treatment is used by physicians to heat skin and promote tissue tightening and contouring. RF technology
produces an electric current that generates heat through resistance in the dermis and subcutaneous tissue. The
thermal effect depends on the conductivity features of the treated tissue. When heated, collagen fibrils will denature and
contract, which is believed to lead to the observed tissue tightening.
Methods: Ninety-three consecutive patients with mild to moderate laxity were included in the study. The Surgitron Dual
Frequency™ RF (Radiowave technology, Ellman International) was used to treat skin laxity. The application of RF energy
took place in an ambulatory setting with no need for skin sterilization or anesthesia.
Results: Patients immediately noticed a microlifting retraction in the treated tissues according to the vectors mapped
in the area. There were no significant complications and the majority of patients were satisfied with the procedure and
able to return to their daily routine after leaving the office, thereby substantiating the popularity of noninvasive rejuvenating procedures.
Aton M. Holzer MD, Frank Martiniuk PhD, William R. Levis MD
Heat-shock proteins (HSPs) serve as both a valuable target as well as a potent tool in the therapy of melanoma and human
papillomavirus infections. HSPs have been found to associate with key pathogenic antigens and, under different circumstances,
activate or suppress both innate and adaptive immunity via several mechanisms. The dominant mechanism
of HSP is as a chaperonin to upregulate antigens on antigen-presenting cell surfaces. While no HSP-based therapies are
currently FDA approved, several are currently in phase III clinical trials. This study reviews the current literature on therapeutic
studies of HSP and the significant role these proteins are likely to play in future therapeutic approaches to neoplasms,
infections, and inflammatory diseases of the skin.
Oral valacyclovir’s efficacy and tolerability as suppressive therapy versus episodic therapy were compared for recurrent
herpes labialis (RHL). Subjects with a history of at least 3 RHL episodes in the past year were randomized to receive 6
months of oral valacyclovir episodic therapy at the first sign of prodrome (two 2-g doses separated by 12 hours) and 6
months of oral valacyclovir suppressive therapy (1 g once daily) for 6 months in open-label, crossover fashion. The
mean±SE number of recurrences per 120 days of follow-up (primary endpoint) was lower with suppressive therapy
(0.30±0.41) than episodic therapy (0.71±0.79) (P<.005). The probability of remaining recurrence free over 6 months
was significantly higher with suppressive therapy than episodic therapy. The median time to first recurrence was 81 days
with episodic therapy and was not calculable (>180 days) for suppressive therapy (P=0.021). Data for secondary efficacy
endpoints (pain severity score, mean duration of recurrences, maximal total lesion area) showed approximately a 30%
to 50% reduction in mean values with suppressive therapy compared with episodic therapy, but results were statistically
significantly different between the regimens for pain severity only. The percentage of subjects with at least one adverse
event over 6 months of treatment that was considered to be drug related was 3% with suppressive therapy and 6% with
episodic therapy. Suppressive therapy with oral valacyclovir was more effective than episodic therapy with oral valacyclovir
in reducing the frequency of recurrences of herpes labialis and prolonging the time to first recurrence and was also
Kosta Y. Mumcuoglu PhD, Stephen C. Barker PhD, Ian F. Burgess MSc, Catherine Combescot-Lang PhD, Robert C. Dalgleish PhD, Kim S. Larsen PhD, Jacqueline Miller PhD, Richard J. Roberts MB BS DCH MPH, Aysegul Taylan-Ozkan MD PhD
Head louse infestations are increasing or remain high in most countries. In order to reduce the proportion of children
infested with head lice and slow down the emergence of strains of lice resistant to pediculicides, more active involvement
of health and educational authorities, as well as parents, is of paramount importance. We suggest that health authorities
should introduce more efficient methods for evaluating pediculicides and more stringent regulations for adoption of new
anti-louse products. Baseline studies are also essential for new pediculicides. Children should be properly screened, especially
in problematic areas. The media should be used to educate parents on louse control. Health providers need to
be aware of which anti-louse remedies are demonstrably effective and be capable of assisting families with louse control.
Academic institutions should conduct baseline and efficacy studies on pediculicides and other treatment modalities, as
well as research on the biology and epidemiology of lice. Parents should regularly inspect their children, treat as necessary,
and try to avoid creating stigmas and emotional problems for the child. The pharmaceutical industry should aim to
introduce pediculicides based on new chemical compounds, especially natural products. Companies should develop effective
and safe repellents and nit removal remedies. General recommendations are given on how to diagnose and treat
louse infestations with chemicals, biological agents, and louse combs and how to protect children from infestations. The
no-nit policy, based on the persistence of empty egg cases, is not justified and does more harm than good; therefore, we
recommend that it be immediately halted.
Mark Boguniewicz MD, William Abramovits MD, Amy Paller MD, Diane L. Whitaker-Worth MD, Mary Prendergast MBA, J. Wang Cheng, Patrick Wang, Kuo B. Tong MS
Atopic dermatitis (AD) increases health care utilization, affects patient quality of life, places a burden on caregivers, decreases
patient/parent productivity, and adds to health care costs. Few studies have examined the effect of specific treatment modalities
across a variety of AD-related outcomes. This prospective, multicenter, open-label longitudinal study of adult and pediatric
patients with moderate to severe AD was conducted to evaluate the effect of a specific therapeutic intervention on
AD-related outcomes over a period of 6 months. Surveys collected physician clinical assessments and patient- and caregiverreported data across the following domains: clinical outcome, health care utilization/costs, quality of life, physical appearance, productivity/absenteeism, and medication compliance. This study is intended to help guide future research efforts on the net costs and benefits of different interventions across a diverse set of domains and in larger populations.
Melissa A. Magliocco MD, Ann Marie Lozano RN BSN CCRC, Claudia Van Saders RN CCRC, Kristine W. Schuler MS, Alice B. Gottlieb MD PhD
Eleven patients with well-controlled psoriasis on cyclosporine (Physician’s Global Assessment [PGA] of “mild” or better)
participated in an open-label study that evaluated a strategy for transition to alefacept. Using this transition strategy, 7 of
11 patients (64%) maintained PGA scores. Quality of life improved or was maintained in all patients. Adverse events and
reductions in CD4+ T cell counts were consistent with those seen during alefacept monotherapy.
Mark Lebwohl MD, Alan Menter MD, Jonathan Weiss MD, Scott D. Clark MD, Javier Flores MD, Jerold Powers MD, Arthur K. Balin MD, Steven Kempers MD, Robert J. Glinert MD, Thomas Fleming MD, Yin Liu PhD, Michael Graeber MD, David M. Pariser MD
Background: Psoriasis is a chronic skin disorder affecting approximately 2% of the US population. Psoriasis may occur
anywhere on the body with initial presentation usually seen between 15 and 30 years of age. Calcitriol 3 ?g/g ointment
has demonstrated good clinical efficacy as well as topical and systemic safety when used to treat psoriasis.
Objectives: To confirm the efficacy and safety of calcitriol 3 ?g/g ointment versus its vehicle in the treatment of subjects
with mild to moderate chronic plaque psoriasis.
Methods: Suitable subjects were randomized to receive either calcitriol 3 ?g/g ointment or its vehicle twice daily for up
to 8 weeks in 2 multicenter, randomized, vehicle-controlled, double-blind parallel group studies. Efficacy was evaluated
through a Global Severity Score dichotomized in success (clear and minimal) or failure. Erythema, plaque elevation, scaling
and dermatologic sum score (sum of the scores for erythema, plaque elevation, and scaling), pruritus, and global improvement
were also assessed. Routine safety and clinical laboratory parameters, including calcium homeostasis, were
evaluated throughout the study.
Results: In total, 839 subjects were included in the 2 studies: 419 patients received calcitriol 3 ?g/g ointment and 420
received the vehicle. In both studies, calcitriol 3 ?g/g ointment was shown to be significantly more effective than its vehicle,
with onset of therapeutic effect seen as early as week 2 and sustained at all subsequent visits. Calcitriol 3 ?g/g ointment
demonstrated good systemic and local safety profile comparable to its vehicle with no effect on calcium homeostasis.
Conclusion: Calcitriol 3 ?g/g ointment applied for 8 weeks is effective and safe in the treatment of mild to moderate