Janelle M. Vega MDa, Vivian W. Bucay MDb, and Flor A. Mayoral MDa
Radiofrequency has been shown in a number of studies to be effective in tightening the skin of the face and neck. This multicenter study was undertaken to determine the efficacy of a monopolar radiofrequency system (Pelleve S5 Wrinkle Treatment Generator; Ellman International Inc, Oceanside, NY) in tightening the skin of the hands and is the first such study assessing the improvement of skin laxity of the hands. A total of 31 female patients with a median age of 56 years were enrolled in 2 centers. Each had a single hand treated, with randomization of the hand to be treated. A total of 3 treatments were performed at 2-week intervals. Follow-up photos were taken at 45 and 90 days after the final treatment. At 90 days, 89% of patients had visible improvement of the appearance of the treated hand based on the visual Global Aesthetic Improvement Scale. Of these, 50% had visible improvement from baseline, and 39% had marked improvement from baseline. Patients reported only mild to moderate discomfort during the treatment. No adverse events or side effects were reported. Monopolar radiofrequency was found to be safe and effective for treating hand wrinkles.
J Drugs Dermatol. 2013;12(1):24-26.
Christopher B. Zachary FRCPa, Nazanin Saedi MDa, and John Allison PhDb
Background and Objective: Assessing the efficacy of noninvasive fat removal relies on measurements that are subject to error and subjective comparisons. Even the integrity of photographic comparisons, an accepted assessment tool, is difficult to control. With the emergence of noninvasive fat reduction technologies, there is a greater need for standardized assessments of efficacy.
Materials and Methods: A geometric model is described that correlates circumference and fat layer changes following noninvasive body contouring procedures. To validate the geometric model, abdominal measurements were taken with and without an artificial fat pad in place with: 1) a tape measure, 2) ultrasound, and 3) micrometer. The model was then used to analyze the published results of fat layer reduction and circumference changes following noninvasive body contouring procedures.
Results: While there was a high correlation (R2=0.8943) between our ultrasound method and the model with 6 subjects, the correlation between the tape measure method and the model was low (R2=0.0142).
Conclusion: Our results underscore the need for a highly accurate and standardized method for fat measurement. The efficacy in previous studies that had been assessed by tape measure in combination with ultrasound or computed tomography imaging does not conform to the model prediction, which leads us to conclude that the measurements used in those studies were not reliable. Studies reporting efficacy should use such a geometric model to ensure consistency between various measurement methods and to minimize errors due to weight change and measurement technique.
J Drugs Dermatol. 2013;12(1):27-34.
Gunter H. Willital MDa and Jeannette Simon MDb
Background: Contractubex® (Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a gel containing extractum cepae, heparin, and allantoin with proven efficacy in the prevention of excessive scarring and promotion of physiological scar formation.
Aim: To investigate the efficacy of early initiation of Contractubex in the prevention of excessive scarring and promotion of physiological scar formation.
Methods: In total, 1,268 patients were included in this observational, noninterventional study. Patients were assessed at visit 1 (within 3 weeks of the injury), when treatment was initiated, with subsequent assessments after 2 to 3 months of treatment, and at the end of the study (after 4 to 5 months of treatment). Parameters measured included scar size, color, and pliability (consistency/hardness), as well as patients' and physicians' subjective assessments of treatment efficacy and tolerability.
Results: After 2 to 3 months of treatment, there were statistically significant improvements in color and pliability of the scar, sensation of pain, tension, and pruritus compared with visit 1 (P<.0001). By the end of the study, further statistically significant improvements compared with visit 1 were observed for all parameters. Only about 1% of scars were rated as markedly red or markedly hardened at the final visit. In addition, there was a reduction of 31.5% in mean scar width and of 47.8% in mean scar height at the end of the observation period. A high percentage of patients (85.8%) and physicians (86.6%) rated the treatment as good or very good with respect to prevention of excessive scarring and promotion of physiological scar development. Tolerability was described as good or very good by 92.0% of physicians and 91.5% of patients.
Conclusions: The results of this study suggest that the scar gel is effective in preventing excessive scarring and promoting physiological scar formation when treatment is initiated early. In addition, the treatment was well tolerated.
J Drugs Dermatol. 2013;12(1):38-42.
Mark B. Taylor MDa, Jamal S. Yanaki MS EdDb, David O. Draper PhDc, Joe C. Shurtz BSc, and Mark Coglianese PhDc
Background: Treatment of melasma and postinflammatory hyperpigmentation is often challenging. No ideal short-term and long-term treatment is available. Vitamin C alone and in combination with iontophoresis has been studied and found to be useful; however, no long-term studies have been published.
Methods: In this study, 35 patients (34 female, 1 male) were treated with a novel full-face iontophoresis mask (FFIM) and a proprietary vitamin C (ascorbyl glucoside) preparation. Patients received one in-office treatment and 12 to 24 at-home treatments over 1 to 2 months in conjunction with a strict maintenance regimen consisting of a mandelic/malic acid skin care regimen, broad-spectrum ultraviolet A/ultraviolet B sunblock, a wide-brimmed hat, and sun-avoidance behavior. Follow-up after the initial in-office treatment ranged from 1 to 54 months (mean, 26 months). Four independent observers graded improvement of melasma and PIH using a 4-point scale. Before the study, high-performance liquid chromatography was used to verify iontophoretic penetration of vitamin C into the skin to a level of 0.2 cm in healthy volunteers (2 male, 2 female).
Results: A mean 73% improvement in abnormal pigmentation was observed at the end of FFIM/vitamin C treatment. Greater than 25% improvement was observed in 32 of 35 patients, and greater than 50% improvement in 22 of 35 patients. Melasma Area and Severity Index scores demonstrated substantial improvement from baseline for all patients, with a mean improvement of 15.7.
Conclusions: Full-face iontophoresis of vitamin C appears to be an effective short-term treatment for melasma and postinflammatory hyperpigmentation. A protocol of strict sun avoidance in combination with a mandelic/malic acid skin care regimen appears to be useful in maintaining the improvement.
J Drugs Dermatol. 2013;12(1):45-50.
Amanda Dahl BS, Margarita Yatskayer MS, Susana Raab BS, and Christian Oresajo PhD
Hydroquinone (HQ) is the benchmark prescription agent for skin lightening. However, HQ use is recently banned in Europe and in parts of Asia because of potential long-term consequences, including carcinogenesis when orally consumed. This has resulted in development of alternative skin-lightening agents with comparable efficacy to HQ, but better safety profiles. This study examined the skin-lightening ability of a topical product containing 0.5% ellagic acid and 0.1% salicylic acid and compared its efficacy with that of a prescription generic 4% HQ product. Fifty-four multiethnic subjects were randomly assigned to use the topical test formulation or generic 4% HQ twice daily for 12 weeks to evaluate product tolerability and efficacy. Under the conditions of this double-blinded clinical study, the test product demonstrated comparable tolerance and efficacy to that of a benchmark product 4% HQ, as assessed by clinical grading, physical measurement of spot size using image analysis, and questionnaire response analysis. This study suggests that this new product provided comparable skin depigmentation benefit to the benchmark product. In addition, the product appears to have better esthetics (texture, pleasantness to use, skin feel) than the 4% HQ product.
J Drugs Dermatol. 2013;12(1):52-58.
Rebecca Kleinerman MD, Thomas H. King MD, and Daniel B. Eisen MD
The treatment of facial cysts often entails some thorny decision making for the dermatologist. We offer a review of several approaches for their removal or modification and examine the outcome evidence for some common techniques and some that are seen less often. Finally, we offer our recommendations based on this trial evidence.
J Drugs Dermatol. 2013;12(1):60-65.
Kavitha K. Reddy MDa, Jeremy A. Brauer MDa, Munir H. Idriss MDb, Robert Anolik MDa,Leonard Bernstein MDa, Lori Brightman MDa, Elizabeth Hale MDa, Julie Karen MDa,Elliot Weiss MDa, Dirk Elston MDb, and Roy G. Geronemus MDa
Background and Objective: Pulsed dye laser treatment often results in port-wine stain (PWS) improvement; however, results vary. A frequency-doubled neodymium-doped yttrium aluminum garnet (Nd:YAG) laser that allows for shorter pulse widths along with large spot sizes and high fluences has been developed for the treatment of cutaneous vascular lesions.
Study Design: A prospective, controlled study was performed in 5 adults with PWS using a frequency-doubled Nd:YAG laser (Excel V; Cutera Inc, Brisbane, CA) in 4 quadrants, using spot sizes of 6 to 10 mm, fluences of 4.8 to 9 J/cm2, and pulse durations of 3 to 6 ms. An adjacent control area was not treated. Each was assessed immediately posttreatment for purpura and edema and at 1 month for PWS color, size, texture, and thickness. Skin biopsies obtained immediately after and at 1 month posttreatment were evaluated.
Results: All treatment quadrants displayed purpura. At 1-month follow-up, all treatment quadrants showed at least 1 grade of color improvement, from a minimum of 1% to 25% to a maximum of 51% to 75% improvement (12/20 quadrants with 1%-25% improvement, 3/20 with 26%-50%, 5/20 with 51%-75%, and 0/20 with 76%-100%). Histologic evaluation of treatment quadrants revealed vascular changes ranging 0.35 to 4 mm in depth. Immediately posttreatment, thrombi and extravasated red blood cells were observed in treatment quadrants. Histology at 1 month revealed decreased number and diameter of vessels in treatment quadrants (superficial vessels decreased by mean 1.1 vessels per section [13%], and diameter by 3.0 μm [47%], midlevel vessels decreased in number by 2.3 [20%], diameter by 2.42 μm [25%], and deep vessels decreased in number by 1.5 [83%], and diameter by 7.44 μm [88%]).
Conclusions: A single treatment with a short pulse width, frequency-doubled Nd:YAG laser resulted in safe and effective improvement of PWS, with up to 75% improvement in color observed at 1 month. Histologic evaluation demonstrated vascular injury at depths of 0.35 to 4 mm with a reduction in vessel number and size at multiple dermal levels.
J Drugs Dermatol. 2013;12(1):66-71.
Ravi Jandhyala MSc(Lond) MBBS(Lond) MRCS(Glasg) MFPM
Background: Despite the escalating number of patients undergoing aesthetic BoNT-A procedures, a standardized, objective means of setting treatment goals and measuring the success of treatment is lacking. Treat-To-Goal (TTG) is a new approach to consent that utilizes the Merz Aesthetics Scale to set objectively defined start points and treatment goals to better inform the consent process and provide a means of measuring the success of treatment.
Objective: To evaluate the TTG approach vs standard consent procedures in terms of patient understanding of the risks and benefits of treatment.
Methods: This study was undertaken in 2 phases among consecutive patients presenting for BoNT-A treatment. Phase 1 consisted of a crossover comparison of patient satisfaction with standard consent vs the TTG approach (n=20). Patient understanding of the likely outcomes and risks associated with treatment following consent and their overall preference were assessed using 10-point visual analog scales (VAS). Phase 2 assigned patients to receive no treatment (n=10) or treatment with BoNT-A (n=54) following consent with the TTG approach. Patients were followed up with 28 days later to assess whether the goals defined during consent had been met.
Results: The TTG approach significantly improved patient understanding of likely outcomes of BoNT-A treatment compared with standard consent (P=.004 when standard consent assessed first, and P=.002 when TTG assessed first). All patients assessed preferred the TTG approach (median VAS score in favor of TTG: 7.0, P<.0001). Target improvements were successfully met or exceeded in at least one treatment area (forehead, glabellar lines, crow's feet) in all patients treated with BoNT-A. In contrast, none of the untreated patients met their target improvements unless the target was defined as no change.
Conclusion: The TTG approach represents a significant improvement over standard consent in terms of the information it provides to patients. Further investigation of this concept is warranted.
J Drugs Dermatol. 2013;12(1):72-78.
Berthold Rzany MD ScMa, Alina A.M. Fratila MDb, Tanja C. Fischer MDc, Said Hilton MDd, Tatjana Pavicic MDe, Alexander Rothhaar MDf, Gerhard Sattler MDg, Boris Sommer MDh,and Andy Pickett PhD BSci
The botulinum neurotoxin (BoNT) product Azzalure (manufactured by Ipsen Biopharm Limited, Wrexham, UK; distributed by Galderma), measured in Speywood units (s.U) has been available since 2009 for temporary improvement in the appearance of moderate to severe glabellar lines. Although we know much about the use of Azzalure for aesthetic indications, some aspects of product use in the clinic still require an update based on continuing and prevailing misconceptions and new clinical data. Therefore, a group of experts experienced with the use of Azzalure convened to formulate the following recommendations: (1) The key to an optimal effect is adequate dosing per injection point. Ten s.U are indicated for strong muscular activity, 5 s.U for medium activity, and approximately 2 s.U for minor activity. (2) The main factor that influences the area of effectiveness is the dosage per injection point. (3) In contrast to former beliefs, we know now that Azzalure works very fast, with some patients reporting initial drug activity after hours. (4) Various volumes can be used for dilution. However, the first choice is the recommended volume, 0.63 mL per vial of 125 s.U. Nevertheless, for clinicians changing products, keeping the volume they are used to might be an option. (5) Clinicians changing products have to be very careful not to confuse the units between different products. (6) In aesthetic BoNT-A usage, the development of antibodies is very rare and is not the common reason for insufficient results. (7) Probably the most common reason when BoNT-A is not working is the absolute or relative underdosage. The present adjunctive recommendations elaborated in an informal expert meeting should help physicians to optimize their treatment with Speywood unit products.
J Drugs Dermatol. 2013;12(1):80-84.
An excess of 70 million cutaneous surgical procedures are conducted annually in the United States that may result in scarring. Skin scars are a normal outcome of the tissue repair process. However, individuals with abnormal scarring may have aesthetic, psychological, and social consequences. As a result, there is a high patient demand for products that will reduce the scarring.
The principles underlying scar formation are now better understood. Products are being developed to address those critical components of the wound-healing process, namely inflammation, hydration, and collagen maturation. A multicomponent scar product was previously shown effective in preventing exaggerated scarring in patients undergoing various surgical procedures. The present outpatient study was conducted in patients undergoing shave biopsies. Following reepithelialization, this investigator-blinded, randomized, 8-week trial compared twice-daily application of either the scar product or the standard of care, white petrolatum. Evaluation visits were conducted at baseline and at weeks, 1, 2, 4 and 8. Subjects were evaluated by the blinded investigator for clinical efficacy and tolerability using grading scales. Standardized digital photographs were taken at each visit, and subjects completed a self-assessment questionnaire regarding treatment effectiveness and satisfaction. Twenty-eight subjects completed the 8-week study. The scar product provided earlier improvements than the white petrolatum. At week 1, 70% of subjects receiving the scar product demonstrated at least 50% global improvement in scar appearance vs only 42% of the subjects receiving white petrolatum. The more rapid improvement was accompanied by greater reductions in stinging/burning and itching with the scar product at all visits. Importantly, there was also greater subject satisfaction with the scar product at all visits. This scar product may be useful in hastening the healing of cutaneous shave biopsies and reducing the stinging/burning and itching associated with the normal healing process.
J Drugs Dermatol. 2013;12(1):86-90.
Alan Menter MD,a Linda Stein Gold MD,b Michael Bukhalo MD,c Steven Grekin DO,d Steven Kempers MD,e Brent M. Boyce MD,f Cecilia Ganslandt MD, gJohn Villumsen MSc,h and Mark Lebwohl MDi
Background/Objectives: A combination topical suspension/gel containing calcipotriene plus betamethasone dipropionate has been developed as a safe and effective treatment for patients with psoriasis vulgaris of the scalp. This same preparation has the potential to be a convenient, effective, and cosmetically appealing formulation for psoriasis on the body. This trial evaluated the efficacy and safety of a topical suspension containing calcipotriene plus betamethasone dipropionate compared with its constituent components and topical suspension vehicle in the treatment of mild to moderate psoriasis on the trunk and limbs.
Methods: This was a randomized, double-blind, vehicle-controlled, 4-arm trial in 1,152 subjects. The co-primary efficacy end points were the proportion of subjects achieving controlled disease based on the Investigators' Global Assessment of disease severity at weeks 4 and 8. Adverse events, vital signs, and clinical laboratory measurements were also assessed.
Results: At week 4, a greater proportion of subjects in the calcipotriene plus betamethasone group achieved controlled disease compared with subjects in the calcipotriene-only and vehicle-only treatment groups. At week 8, a statistically significantly (P<.01) greater proportion of subjects in the calcipotriene plus betamethasone group achieved controlled disease compared with subjects in the 3 other treatment groups. Adverse events and other safety assessments were similar between the groups.
Conclusion: The topical suspension containing calcipotriene plus betamethasone dipropionate traditionally used for scalp psoriasis is also a safe and effective once-daily treatment for psoriasis vulgaris on the body.
J Drugs Dermatol. 2013;12(1):92-98.
Robert A. Swerlick MD aand Caren F. Campbell MD b
Excipients are defined as inert substances added to a drug or food to confer a suitable consistency, appearance, or form. They may be added for bulk, to change dissolution or the kinetics of absorption, to improve stability, to influence palatability, or to create a distinctive appearance. The last function may depend heavily on the use of coloring agents, especially when there are multiple dosages (such as with warfarin), and dose confusion may result in profound complications. While described as inert, excipients have been associated with triggering immunological reactions, although this is almost never considered in common practice when patients have reactions to medications, even when they appear to react to many different and distinct drugs. We have found a cohort of 11 patients with chronic, unexplained pruritic skin disorders that have responded to medication changes centered around avoidance of coloring agents, particularly FD&C Blue No. 1 (bright blue) and Blue No. 2 (indigo carmine). We believe that reactions to agents that color medications and foods may be more common than previously appreciated and that recognition of this phenomenon may provide therapeutic alternatives to patients with intractable pruritic disorders.
J Drugs Dermatol. 2013;12(1):99-102.
Zoe D. Draelos MD a, Steven R. Feldman MD PhD b, Victoria Butners BSc c, and Alessandra B. Alió Saenz MD c
Background: Ketoconazole foam, 2%, is approved in the United States for seborrheic dermatitis therapy in immunocompetent patients aged ≥12 years. While short-term trials have demonstrated its safety and efficacy, seborrheic dermatitis often requires long-term treatment.
Objective: To assess the long-term safety of ketoconazole foam, 2%, twice daily, as required.
Methods: A 12-month, open-label, multicenter study. Subjects were evaluated at baseline and at weeks 4, 8, 16, 26, 39, and 52 (or early termination [ET]) for adverse events (AEs), serious AEs (SAEs), target lesion erythema, scaling, and pruritus, as well as Investigator's Static Global Assessment (ISGA) scores. Physical examinations were performed at baseline and at week 52/ET, and laboratory evaluations at baseline and at weeks 8, 26, and 52. A poststudy product-preference questionnaire was completed.
Results: Of 500 subjects enrolled, 498 were included in the safety population, and 363 completed the study. Overall, 57% of subjects reported ≥1 AE. Treatment-related AEs occurred in 14% of subjects, including application-site irritation (8%), application-site pain (4%), application-site pruritus (1%), and increased alanine aminotransferase (1%). Seven subjects were withdrawn because of treatment-related AEs. No SAEs (21 in 17 subjects) were considered to be related to study drug. Mean target lesion erythema, scaling, and pruritus scores improved by 2 units from baseline at all study visits; mean ISGA score improved by 1 unit at week 4 and by 2 units at subsequent visits. The foam vehicle was preferred by 67% of subjects.
Limitations: Evaluation of severity was limited to target lesion; no objective measure of adherence.
Conclusion: The long-term safety profile of ketoconazole foam, 2%, in subjects with seborrheic dermatitis was favorable and efficacy was maintained. This trial was registered at clinicaltrials.gov (NCT00703846).
J Drugs Dermatol. 2013;12(1):e1-e6.
Omar A. Azzam MD a, Ahmed T. Atta MDb, Rehab M. Sobhi MD, and Pakinam I.N. Mostafa MSca
Background: Acne scars present a highly challenging and frustrating clinical problem. Fractional CO2 laser treatment has led to marked improvement in scars, and fat transfer, or fat grafting, has also recently proven very useful in regenerative medicine.
Objective: To compare fractional CO2 laser treatment and fat grafting in the treatment of acne scars.
Materials and methods: Twenty patients were included in this study, 10 received 3 sessions of fractional CO2 laser therapy, and 10 received fat grafting. All patients were then followed up for 3 months, and results were assessed with digital photographs taken by a committee of 3 physicians, by a single-blinded physician, and by reports of patient satisfaction.
Results: In the fractional CO2 laser treatment group, under 20% of patients were graded as having excellent scar improvement, 0 as having marked scar improvement, under 10% as having mild scar improvement, and almost 70% as having moderate scar improvement. In the fat-grafting group, the scar and overall improvement were graded as 30% excellent, 30% marked, 20% moderate, and 20% mild.
Conclusion: Fat grafting proved to be more effective in the treatment of acne scars than ablative fractional CO2 laser treatment. There were many points in its favor, the most significant being the clinical improvement in scars and texture. This supports the stem cell theory of adipose tissue in regenerative medicine.
J Drugs Dermatol. 2013;12(1):e7-e13.
Habibollah S. Alamdari BAa , Cheryl J. Gustafson MDa , Scott A. Davis MAa , William Huang MD MPHa , and Steven R. Feldman MD PhDa-c
Background: Guidelines to screen for cardiovascular (CV) risk factors in psoriasis patients have been established. However, the frequency with which dermatologists and nondermatologists screen psoriasis patients for CV risk factors is not well characterized.
Purpose: To determine how frequently psoriasis patients are screened for CV risk factors in the ambulatory care setting and to identify factors affecting screening rates.
Methods: Data from the 2005 to 2009 National Ambulatory Medical Care Survey (NAMCS) were analyzed to determine screening rates for blood pressure, glucose, cholesterol, and body mass index (BMI). The probability of a patient having at least 1 of the 4 risk factors screened was determined and was termed the "composite" score. Screening rates were assessed by physician specialty, patient demographics, and clinical practice characteristics.
Results: There were an estimated 11.4 million psoriasis patient visits from 2005 to 2009. Blood pressure, glucose, cholesterol, and BMI were evaluated at 32.2%, 5.9%, 9%, and 26% of psoriasis visits, respectively, with a composite score of 41.2%. Patients without psoriasis were screened for these CV risk factors at 59.0%, 6%, 8%, and 38.1% of outpatient visits, respectively, with a composite score of 66.3%. The results of a multivariate analysis accounting for patient age differences indicated psoriasis had a statistically significant effect on rates of blood pressure and BMI screening. In general, screening rates were higher if the patient was male, African American, or non-Hispanic, and screening rates were relatively equal across age groups. Higher screening rates were also associated with primary care specialties, faculty practice or community health clinics with contracted physicians, clinics that utilized electronic medical records, practices with a higher percentage of revenue from a Medicare/Medicaid payer, or offices with discounted fees and capitation payment structures.
Limitations: Data from NAMCS are cross-sectional, permitting assessment of screening rates based on visits but not on patients.
Conclusions: Screening for high blood pressure, diabetes, hypercholesterolemia, and obesity are not performed at most outpatient visits for psoriasis. Care should be taken to ensure that patients do receive appropriate screening for the comorbidities associated with psoriasis.
J Drugs Dermatol. 2013;12(1):e14-e19.