Avnee Shah BS, Jenna ONeill MD, Steven R. Feldman MD PhD
Background: Alefacept has an established efficacy and safety profile for 12 weeks of treatment of severe chronic plaque type psoriasis. The effectiveness and safety of longer-term continuous use is not well characterized.
Methods: Fifteen subjects with moderate-to-severe chronic plaque type psoriasis were given weekly 15 mg alefacept injections for 16 consecutive weeks followed by monthly 15 mg injections for up to eight consecutive months, along with clobetasol propionate spray 0.05% twice daily for the first four weeks. Disease severity was measured using the Psoriasis Area and Severity Index (PASI) and the Investigator Global Assessment (IGA).
Results: Mean PASI scores improved 33 percent overall during the first month with combination treatment. There was an overall 21 percent worsening in PASI scores after the transition from weekly to monthly medication administration. Of the 15 initially enrolled patients, 27 percent achieved PASI 75 by end of study. No patients achieved an IGA of 0 or 1 by end of study. Two major adverse events were reported: low CD4 count and severe allergic dermatitis.
Conclusion: Topical clobetasol propionate 0.05% was only partially effective at augmenting the early treatment effect of alefacept. The authors did not observe marked benefit or major side effects by continuing additional monthly alefacept treatments beyond 16 weeks of weekly treatment.
Lidocaine Gel in a Unique Drug Delivery SystemLeslie S. Baumann MD, Lisa Grunebaum MD, Mohamed L. Elsaie MD, Jennifer Murdock BS, Eric Jablonka BS, Kristian Figueras MS, Michaela Bell BS
Background: Ideally, topical anesthetics should provide rapid analgesic action without causing toxic blood levels of lidocaine or other side effects. Various formulations of lidocaine as a topical anesthetic have been tested and are currently on the market. Here, the authors report on a topical lidocaine with a novel delivery system that provides a rapid onset of action without toxic plasma levels of lidocaine.
Objective: Study 1 assessed the time needed for a topical 4% lidocaine gel with a unique drug delivery system to produce optimal anesthetic effects. Study 2 assessed lidocaine plasma concentrations and assessed the time to maximal anesthetic effect.
Methods: In both studies, subjects received six botulinum toxin type A injections for crow’s feet wrinkles in six separate zones in
the lateral periocular regions bilaterally. The first injection was administered in the absence of topical 4% lidocaine gel. Gel was then applied to the remaining five zones and injections were given at set time points out to 45 minutes. In study 2, blood samples were taken from baseline to 60 minutes.
Results: Significant anesthetic effect with topical 4% lidocaine gel was attained without occlusion in approximately 25–30 minutes.
However, optimum effects were observed between 35–40 minutes after application. Additionally, topical 4% lidocaine, when used
appropriately, did not produce lidocaine plasma levels associated with toxicity.
Conclusion: Topical 4% lidocaine gel with a unique drug delivery system produces significant anesthesia without occlusion in approximately 25–30 minutes with optimal effects observed between 35–40 minutes after application. Topical 4% lidocaine gel can be used effectively and safely as a topical anesthetic in the physician’s office.
Neil S. Sadick MD, Michel Le Maître MD, Christine Coutanceau MS,Vincent Sibaud MD, Christelle Merial-Kieny PhD
Background: Palmoplantar keratoderma (PPK) is a heterogeneous group of skin disorders characterized by symmetrical diffuse or
patchy areas of hyperkeratosis on the palms and soles. This study aimed to evaluate the efficacy and safety of a topical keratolytic treatment for localized hyperkeratosis.
Methods: International, randomized, vehicle‑controlled, double‑blind, intra‑individual comparative study.
Results: Clinical signs assessed by the investigator significantly improved in both group from baseline to day 10 and day 21 (P<0.001). Mean improvement was significantly more marked on the treated side than the control side (except pruritus) at day 10 for hyperkeratosis (‑0.58±0.59 versus ‑0.41±0.51, P=0.009), desquamation (‑0.62±0.69 versus ‑0.47±0.67, P=0.042) and dryness (‑0.75±0.67 versus ‑0.57±0.67, P=0.014). At day 21, dryness (‑1.16±0.80 versus ‑1.00±0.79, P=0.036) was significantly improved but only a trend for hyperkeratosis (‑0.86±0.76 versus ‑0.72±0.72, P=0.158) and desquamation (‑0.83±0.85 versus ‑0.65±0.85, P=0.057) was observed.
Tolerance was considered to be good or very good in more than 92 percent patients. Both patients and investigators were satisfied in more than 84 percent of cases with the topical keratolytic treatment efficacy. Safety profile was highly satisfactory.
Conclusion: This topical keratolytic treatment represents a valuable first‑line option for mild to moderate hyperkeratosis.
Ariel Hasson MD and William A. Romero MD
Background: The treatment of atrophic scars is difficult and dermal filler materials provide a simple alternative with immediate results. Esthélis® is an injectable non-animal crosslinked hyaluronic acid of Swiss origin characterized by a polydense cohesive matrix (CPM®) which produces a gel of uniform consistency with better biointegration to the tissues and a longer duration.
Objective: To evaluate Esthélis in the treatment of atrophic scars.
Patients and Methods: Twelve patients aged 18–56 years with facial atrophic scars caused by acne vulgaris, dog bite, piercing,
basal cell carcinoma and leishmaniasis were treated with Esthélis. The injection technique was linear threading, serial puncture or a
combination of both. Clinical efficacy was assessed independently by the authors and by patients immediately, one week and one month after the injection. Adverse events were registered.
Results: Authors described the results as moderate (27%), good (57%) and excellent (17%), immediately, one week and one month
after the injection. Patients evaluated the cosmetic improvement as good (42%) or excellent (58%) one month after the treatment.
Pain during the injection was described as slight or moderate. Only mild erythema was observed immediately after injection, which spontaneously resolved within few hours.
Conclusion: Esthélis showed good or excellent results in most patients with atrophic scars, and these were perceived as even better when patients evaluated the cosmetic improvement. The best results were observed in patients with more deforming scars such as surgical scars or trauma.
Telia DeBoyes MD, David Kouba MD, David Ozog MD, Edgar Fincher MD, Lauren Moy, Kathryn Iwata, Ronald Moy MD
Background: Actinic keratosis is regarded as a carcinoma in situ by some dermatologists and its incidence continues to rise. Exposure to ultraviolet (UV) radiation is considered to be an important risk factor for developing these pre-malignant lesions. DNA repair enzymes have been shown to reverse sun-damage, resulting in reduced rates of actinic keratoses and non-melanoma skin cancers in specific patient populations.
Methods: Seventeen patients were evaluated for differences in actinic keratoses following topical application of T4N5 liposome lotion over 48 weeks.
Results: Compared to baseline, a statistically significant reduction in the number of actinic keratoses was seen following the treatment period.
Discussion: This study suggests that DNA repair enzyme creams effectively reduce the number of actinic keratoses in normal individuals with moderate-to-severe photodamaged skin.
Jared Jagdeo MD MS, Lauren Adams MD, Hadar Lev-Tov MD,Jolanta Sieminska BS, Josef Michl MD, Neil Brody MD PhD
The study of free radicals is particularly relevant in the context of human skin carcinogenesis and photoaging because of their ability to induce DNA mutations and damaging lipid peroxidation byproducts. Therefore, it is important to identify and evaluate agents with the ability to modulate intracellular free radicals. Significant interest exists in evaluating the chemotherapeutic and anti-oxidant properties of resveratrol (trans-3,4’,5-trihydroxystilbene). Resveratrol is a phytoalexin, a naturally occurring compound derived from the skin of grapes and other plants. Resveratrol was selected for evaluation because of demonstrated chemopreventive and chemotherapeutic
properties in a murine skin cancer model and other human cancer models through a variety of mechanisms. However, the intracellular anti-oxidant properties of resveratrol on free radicals in human skin cells in vitro is not well characterized. The purpose of this research is to investigate the ability of resveratrol to modulate the hydrogen peroxide-induced upregulation of reactive oxygen species (ROS) free radicals in normal human skin fibroblast cells in vitro. Hydrogen peroxide is a well known generator of free radicals that occurs during endogenous and UV-induced oxidation processes in the human skin and was used to upregulate ROS in normal human skin fibroblast cells. Using a flow cytometry-based assay, the results demonstrate highly significant (P<0.001) dose-dependent reduction
of intracellular hydrogen peroxide-upregulated ROS by resveratrol at 0.01%, 0.001% and 0.0001% concentrations in human skin fibroblasts in vitro.
Debbie M. Palmer DO and Jennifer Silverman Kitchin MD
Objective: This 12-week, double-blinded, randomized, controlled clinical usage study was conducted to evaluate the efficacy and tolerance of a novel topical, multi-ingredient, polyphenol, high antioxidant skin care system (facial wash, day lotion, night crème and eye serum) to reduce the appearance of photoaging. Methods: A total of 40 Caucasian female participants were randomly assigned to apply the test regimen or control regimen for 12 weeks. One group washed with the test antioxidant facial wash twice daily, applied the test antioxidant day lotion each morning and the test antioxidant night creme and eye serum each evening. The second group washed with a control facial wash twice daily and applied a control moisturizer each morning and evening. Clinical evaluations for efficacy were made by a board-certified dermatologist at baseline and after six and 12 weeks of product use. Efficacy was also measured by subjects’ self-assessments and via photography
and instrumentation. Results and Conclusion: Overall, the results of the study showed that the test regimen produced statistically significant improvements in the appearance of photodamaged skin. Most impressive was the significantly greater improvements produced by the test regimen over the control regimen for nearly every grading parameter. The results from this study demonstrate that this high Total ORACsc scoring antioxidant skin care system was well tolerated, with no adverse events reported by the participants during the course of the study, and improved, significantly greater than a control regimen, the appearance of wrinkles, firmness, hyper pigmentation, blotchy redness, tactile roughness and clarity in photodamaged skin. Post-baseline clinical grading scores, silicone replica parameters, cutometer and corneometer scores were statistically compared to baseline using a paired t test at the P≤0.05 significance level.
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.
Kathleen M. Beckum MD, Alde Carlo P. Gavino MD,Shellie Marks MD, Aleodor A. Andea MD, Boni E. Elewski
Wong Type Dermatomyositis: 20th Case Reported
Feng Sun PhD, Robert Anderson PhD, Guillermo Aguilar PhD
Novel cryopneumatic technology (CPx) and photopneumatic technology (PPx) have been developed to enhance the permeation of
the stratum corneum (SC) and percutaneous drug delivery (PDD). CPx produces micro-cracks at the skin surface by successively
freezing and stretching the skin with vacuum suction. PPx combines stretching of the skin by vacuum suction with intense pulsed
light. The enhancing effects of CPx and PPx were studied on ex vivo porcine skin and in vivo human skin models. Fluorescent hydrophilic
macromolecules (FITC and FITC-Dextran) were used as drug surrogates. Fluorescent images of in vivo experiments show
that the enhancing effect of CPx is due to drug permeation through the micro-cracks produced by freezing-stretching cycles, while
PPx could promote drug permeation through sweat glands. Both ex vivo and in vivo results strongly suggest that CPx and PPx can
effectively enhance the permeation of the SC and PDD for the delivery of hydrophilic macromolecules.
Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatologic community.
This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical
experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration
(FDA) approval. We trust you will find this information beneficial to your practice and research.