Anne W. Lucky MD, J. Michael Maloney MD, Janet Roberts MD, Susan Taylor MD, Terry Jones MD, Mark Ling MD PhD, Steven Garrett DDS, for the Dapsone Gel Long-Term Safety Study Group
Dapsone gel 5%, a topical formulation of dapsone, was shown to deliver clinically effective doses of dapsone with minimal
systemic absorption in 2 randomized, vehicle-controlled, 12-week studies of patients with acne vulgaris. A 12-month,
open-label, long-term safety study further evaluated the safety and efficacy of dapsone gel. Patients at least 12 years of age with acne vulgaris (N = 486) applied dapsone gel twice daily for up to 12 months. Application site reactions related to treatment were reported in 8.2% of the patients and were mostly mild to moderate in severity. Common nonapplication
site adverse events included headache (20%) and nasopharyngitis (15%). No significant changes in hematology or blood
chemistry parameters were observed. At one month, mean reduction from baseline in inflammatory lesion counts was 30.6%.
At 12 months, mean reduction from baseline was 58.2%, 19.5%, and 49.0% for inflammatory, noninflammatory, and total
lesion counts, respectively, (all P=.002 compared to baseline). These results show that dapsone gel 5% is safe and effective
for long-term treatment of acne vulgaris and has a rapid onset of action.
Beatriz G. Carpo MD, Vermén M. Verallo-Rowell MD, Jon Kabara MS PhD
Objective: A cross-sectional laboratory study to determine the in vitro sensitivity and resistance of organisms in culture
isolates from skin infections and mechanisms of action of monolaurin, a coconut lauric acid derivative, compared with
6 common antibiotics: penicillin, oxacillin, fusidic acid, mupirocin, erythromycin, and vancomycin.
Methods: Skin culture samples were taken from newborn to 18-year-old pediatric patients with primary and secondarily
infected dermatoses. Samples were collected and identified following standard guidelines, then sent to the laboratory
for sensitivity testing against the 6 selected antibiotics and monolaurin.
Results: Sensitivity rates of Gram-positive Staphylococcus aureus, Streptococcus spp., and coagulase-negative Staphylococcus,
Gram-negative E. vulneris, Enterobacter spp., and Enterococcus spp. to 20 mg/ml monolaurin was 100% and of Klebsiella
rhinoscleromatis was 92.31%. Escherichia coli had progressively less dense colony growths at increasing monolaurin
concentrations, and at 20 mg/ml was less dense than the control. Staphylococcus aureus, coagulase-negative Staphylococcus,
and Streptococcus spp. did not exhibit any resistance to monolaurin and had statistically significant (P <.05) differences
in resistance rates to these antibiotics.
Conclusions: Monolaurin has statistically significant in vitro broad-spectrum sensitivity against Gram-positive and
Gram-negative bacterial isolates from superficial skin infections. Most of the bacteria did not exhibit resistance to it. Monolaurin
needs further pharmacokinetic studies to better understand its novel mechanisms of action, toxicity, drug interactions,
and proper dosing in order to proceed to in vivo clinical studies.
Boni E. Elewski MD, William Abramovits MD, Steven Kempers MD, Joel Schlessinger MD, Theodore Rosen MD, Aditya K. Gupta MD PhD, Sabra Abraham MS, Richard Rowell
Background: A novel topical foam formulation of ketoconazole has been developed for use on the scalp, body, and face.
Objective: To evaluate the efficacy and safety of twice-daily treatment with ketoconazole 2%foam for seborrheic dermatitis
on the scalp, body, and face.
Methods: One thousand one hundred sixty-two subjects, aged 12 years or older, with mild to severe seborrheic dermatitis
were randomized to receive ketoconazole foam (n=427), vehicle foam (n=420), ketoconazole cream (n=210), or vehicle
cream(n=105) twice daily for 4 weeks. The primary endpoint was the proportion of subjects achieving an Investigator’s Static
Global Assessment score of 0 or 1 at week 4 (treatment success).
Results: A significantly greater percentage of subjects achieved treatment success using ketoconazole foam than vehicle
foam (56% and 42%, respectively; P<.0001); ketoconazole foam was shown to be equivalent to ketoconazole cream.
Ketoconazole foam was well-tolerated with a low incidence of treatment-related adverse events (14%; 59/427).
Conclusion: Ketoconazole foam 2% is a safe, effective, and versatile formulation for use on the scalp, body, and face for
the treatment of seborrheic dermatitis in patients aged 12 years or older.
Michael H. Gold MD, Mitchel P. Goldman MD, Julie Biron
Growth factors, in addition to their crucial role in cutaneous wound healing, are also beneficial for skin rejuvenation.
Due to their multifunctional activities such as promoting skin cell proliferation and stimulating collagen formation, growth
factors may participate in skin rejuvenation at various levels. The present placebo-controlled study aimed to further investigate
the antiaging effects of a novel skin cream containing a mixture of human growth factors and cytokines, which
was obtained through a biotechnology process using cultured human fetal fibroblasts. Aside from clinical assessment of
skin wrinkles, the skin surface topography was analyzed by 3D in vivo optical skin imaging using the Phaseshift Rapid in
vivo Measurement of Skin (PRIMOS) device. This device allows fast, contact-free, and direct measurement of the skin
surface topography in vivo at high resolution. This technique is quantitative and more reliable than a visual assessment
of wrinkles using a scoring system, which is subjective and strongly dependent on investigator and assessment conditions.
Using the PRIMOS device, which is also regarded as a more accurate method than the commonly used silicon replica
technique, skin surface roughness was shown to significantly decrease between 10% and 18% depending on the roughness
parameter after 2 months of twice-daily application of the human growth factor and cytokine cream. This was compared
to treatment with the placebo formulation resulting in an approximate 10% decrease of 2 roughness parameters,
whereas the remaining parameters remained unchanged. We found that topical application of growth factors and cytokines
are beneficial in reducing signs of skin aging.
Intense pulsed light (IPL) has been a popular nonablative treatment of photodamage. A prospective, randomized, controlled,
single-blinded, split-face pilot study compared the efficacy and safety of 2 multitechnology broadband pulsed light
platform devices: an IPL device (Lumenis One, Lumenis Corporation, Santa Clara, CA) and a fluorescent pulsed light
with advanced fluorescent technology (AFT, Harmony System, Alma Lasers, Buffalo Grove, IL) device. Eight volunteer
subjects (skin types I-IV) with a 2.0 mean Global Score for Photoaging (scale 0-4) participated in the study. Subjects received
3 to 5 treatments 3 weeks apart in which one side of the face was treated with the IPL device and the other side
with the AFT device. During each treatment session, the face received 3 complete passes without anesthesia. Treatment
was aggressive and parameters were determined by test spot application. Treatment endpoints were mild erythema. Results
were evaluated by clinical observations of the investigator and comparison of pre- and post-treatment photographs
by subjects and 2 blinded dermatologists. Blinded evaluators agreed that improvements in dyspigmentation, telangiectasias,
erythema, and skin texture were similar on both sides of the face. Subject assessments of discomfort during treatment
were also comparable. Adverse effects were not observed.