A Pilot Study of the Safety and Effectiveness of a Novel Device in Subjects With Axillary Hyperhidrosis.

BACKGROUND: One-third of U.S. adults are bothered by excessive sweating and 5% suffer from hyperhidrosis, both of which negatively affect quality-of-life (QoL). A single-use disposable patch using the novel targeted alkali thermolysis (TAT) technology is being developed to address this condition. OBJECTIVE: Assess the efficacy and safety of the TAT patch for the treatment of excessive sweating using a randomized, double-blind, sham-controlled study design. MATERIALS AND METHODS: Adults with Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4 ( n = 16) were treated with an active or sham patch for up to 3 minutes (as established in a previous unpublished feasibility study) and evaluated weekly for 6 weeks post-treatment. The primary effectiveness measure was improved HDSS at Week-4. RESULTS: The study met its objective. For the primary efficacy measure, 83% of TAT-treated subjects reported HDSS scores of 1 or 2 at Week-4 versus 0% of sham-treated subjects ( p = .0032). Furthermore, 67% of TAT-treated subjects had a 2-point improvement in HDSS scores versus 0% of sham-treated subjects ( p = .0123). Quality-of-life improvement correlated with HDSS. The TAT patch seemed to be well-tolerated; one transient moderate adverse event that resolved without sequelae was reported. CONCLUSION: The TAT patch successfully demonstrated efficacy and was well-tolerated.

Effectiveness of a Nutraceutical During Non-Ablative 1927 nm Fractional Laser on Patients With Facial Hyperpigmentation and Photoaging.

Background: Fractional lasers have been proven to treat hyperpigmentation and photoaging. Little research has been done on the effects of supplements on healing post-laser resurfacing. A nutraceutical could offer the benefit of faster healing of the skin and fewer side effects.

Objective: Evaluate the effectiveness of a nutraceutical associated with fractional 1927 nm laser in healing time and effectiveness on hyperpigmentation and photoaging.

Methods & Materials: A prospective, randomized, evaluator-blinded, pilot study included Fitzpatrick skin types I-III patients with hyperpigmentation and photoaging randomly assigned to two groups. Group 1 was laser treatment and Group 2 was laser treatment and nutraceutical. Results were compared with objective biometric TEWL (transepidermal water loss), mexameter, corneometer, and cutometer parameters. A blinded physician-evaluator and the subjects completed questionnaires to evaluate skin improvements.

Results: Twenty women were included. Eight in Group 1 and 10 in Group 2 completed the study. Group 2 presented a faster recovery of the skin barrier function post procedure. Three months after the procedure, Group 2 presented with significantly improved skin glossiness, hydration, and melanin rebound levels. Group 2 presented more overall aesthetic improvement determined by the patient and the blinded physician-evaluator.

Conclusion: The nutraceutical improved the results of the laser treatment.

J Drugs Dermatol. 2017;16(5):501-506.

Effect of Topical Platelet Extract Daily Serum as a Cosmetic Product to Reduce Facial Redness.

Objective: The primary objective of this pilot study was to demonstrate the benefits of topical human platelet extract (plated)™ serum for the improvement of persistent facial redness. Methods: This single-center, open-label pilot study evaluated six subjects using (plated)™ serum containing human platelet extract (HPE) with Renewosome™ technology twice daily for six weeks. The primary efficacy endpoint was a reduction in the Clinical Erythema Assessment (CEA) grade, and a reduction in Patient Subjective Assessment grade at six weeks. Secondary endpoints included an improvement in quality of life related to facial redness, and a reduction in redness by Mexameter™ spectrometry measurement. Safety data included monitoring for adverse events. Results: Topical HPE serum demonstrated a statistically significant improvement in facial redness at Week 9 when averaging the Mexameter™ spectrometry results across nine regions of the face (p=0.0052). The primary and secondary endpoints were achieved. CEA grade at Week 6 demonstrated that all subjects improved by at least one grade, while one subject improved by two grades. One patient reported dryness. No other adverse effects were observed. Limitations: Study limitations included a small sample size and lack of darker skin types (Fitzpatrick IV-VI). Conclusion: This study demonstrates that topical HPE with Renewosome™ technology provides statistically significant reduction in facial redness and is safe and well-tolerated.

Long-term effectiveness and safety of small gel particle hyaluronic acid for hand rejuvenation.

BACKGROUND: Fillers to reverse the effects of fat atrophy can help restore the hands' youthful appearance. OBJECTIVE: To evaluate the effectiveness and safety of small gel particle hyaluronic acid (SGP-HA) for hand rejuvenation through 1 year. MATERIALS AND METHODS: A prospective open-label study recruited adults with moderate to severe vascular, bony, and tendon prominence. After a topical anesthetic was applied, SGP-HA (maximum dose of 4.0 mL) was injected into the dorsum using a threading technique and distributed by massage. RESULTS: There were 16 patients with a mean ± SD age of 60.1 ± 5.3. Two weeks after treatment, vascular, tendon, and bony prominence and skin turgor were improved by 60.9%, 65.2%, 73.7%, and 26.3%, respectively. Substantial or complete global aesthetic improvement was rated in 75% of patients by investigators and in 56% by self-report; 81% of patients were satisfied or very satisfied. Five needed a touch-up (maximum 1.0 mL/hand). Improvements were largely maintained at 6 months, with 85% patient satisfaction, and assessments approached pretreatment levels at 1 year, with 50% patient satisfaction. One patient reported itching on one hand, which was judged to be unrelated to treatment. CONCLUSION: SGP-HA produced lasting improvements in aging hands and was safe and well tolerated.

Investigator global evaluations of efficacy of injectable poly-L-lactic acid versus human collagen in the correction of nasolabial fold wrinkles.

BACKGROUND: Injectable poly-L-lactic acid (PLLA) is indicated in the United States for use in immune-competent patients for correction of shallow-to-deep nasolabial fold contour deficiencies and other facial wrinkles in which a deep dermal grid pattern injection technique is appropriate. It is also indicated for restoration and/or correction of signs of lipoatrophy in patients with human immunodeficiency virus. OBJECTIVE: The authors examine the efficacy of injectable PLLA for correction of nasolabial fold wrinkles, based on Investigator Global Evaluations (IGE). METHODS: A randomized, multicenter, subject-blinded, parallel-group study compared injectable PLLA versus human collagen for correction of nasolabial fold wrinkles for 13 months after up to four treatments (intent-to-treat population, 233). Injectable PLLA-treated subjects were followed up for an additional 12 months (total, 25 months) after the final treatment session. Efficacy was also assessed through secondary IGE for improvement, which is the subject of this report. RESULTS: IGE reports of improvement were significantly greater in subjects who received injectable PLLA versus those who received human collagen (p < .001). Overall improvement with injectable PLLA was 100% three weeks after the final treatment, remaining above 85% through month 25. Overall IGE of improvement with human collagen declined from 94.0% at week three to 6.0% at month 13. Both treatment groups had similar safety profiles. CONCLUSIONS: IGE of improvement were significantly greater with injectable PLLA treatment than with human collagen treatment at all time points following the last treatment. Injectable PLLA treatment continued to show a beneficial effect for up to 25 months.

Efficacy and safety evaluation of a novel botulinum toxin topical gel for the treatment of moderate to severe lateral canthal lines.

BACKGROUND: Botulinum toxin type A (BoNTA) is commonly injected to treat facial wrinkles. Complications include pain, erythema, bruising, and potential infection. RT001 Botulinum Toxin Type A Topical Gel (RT001) is under development for the treatment of lateral canthal lines (LCLs). OBJECTIVE: To assess the efficacy and safety of RT001 for the treatment of LCLs using a randomized, double-blind, repeat-dose, placebo-controlled study design. METHODS & MATERIALS: Healthy adult subjects were randomized to receive RT001 (N=19) or placebo (N=17) applied to their lateral canthal areas (LCAs). To evaluate safety of repeat exposure, treatment was administered at baseline and week 4. The primary efficacy measure was improvement in baseline LCL severity using the Investigator's Global Assessment of Lateral Canthal Line at Rest (IGA-LCL) Severity Scale. RESULTS: At 8 weeks, 19 (50%) LCAs treated with RT001 showed a 2-point or greater improvement in baseline IGA-LCL severity, versus none (0%) of the placebo-treated subjects (p<.001); 36 (94.7%) LCAs treated with RT001 showed a 1-point or more improvement in baseline IGA-LCL severity, versus five (14.7%) placebo-treated LCAs (p<.001). There were no treatment-related adverse events. CONCLUSION: RT001 was well tolerated and demonstrated an improvement in LCLs.

Microscopic and physiologic evidence for biofilm-associated wound colonization in vivo.

A biofilm is a collection of microbial cells that are attached to a surface and embedded in a self-produced extrapolymeric substance. The understanding of the biofilm phenotype is important in the understanding of bacteria in vitro but it has been difficult to translate biofilm science to the clinical setting. More recently, preliminary criteria for defining biofilm associated diseases have been proposed and the purpose of this study was to create a biofilm-associated wound model based on these criteria. Using a porcine model, partial thickness wounds were inoculated with a wound isolate Staphylococcus aureus strain. Wounds were then treated with either one of two topical antimicrobial agents (mupriocin cream or triple antibiotic ointment) within 15 minutes to represent planktonic bacteria or 48 hours after initial inoculation to represent biofilm-associated wound infection. Using light microscopy, scanning electron microscopy and epifluorescence microscopy, we were able to observe biofilm-like structures in wounds after 48 hours of inoculation and occlusion. The in vivo antimicrobial assay was used to demonstrate that both mupirocin cream and the triple antibiotic ointment were effective in reducing planktonic S. aureus but had reduced efficacy against biofilm-embedded S. aureus. Our results demonstrated that S. aureus form firmly attached microcolonies and colonies of bacteria encased in an extracellular matrix on the surface of the wounds. These biofilm-like communities also demonstrated increased antimicrobial resistance when compared with their planktonic phenotype in vivo. The structural and physiological results support the hypothesis that bacterial biofilms play a role in wound colonization and infection.

Self-reported Patient Motivations for Seeking Cosmetic Procedures.

Importance: Despite the growing popularity of cosmetic procedures, the sociocultural and quality-of-life factors that motivate patients to undergo such procedures are not well understood. Objective: To estimate the relative importance of factors that motivate patients to seek minimally invasive cosmetic procedures. Design, Setting, and Participants: This prospective, multicenter observational study was performed at 2 academic and 11 private dermatology practice sites that represented all US geographic regions. Adult patients presenting for cosmetic consultation or treatment from December 4, 2016, through August 9, 2017, were eligible for participation. Exposures: Participants completed a survey instrument based on a recently developed subjective framework of motivations and a demographic questionnaire. Main Outcomes and Measures: Primary outcomes were the self-reported most common motivations in each quality-of-life category. Secondary outcomes were other frequently reported motivations and those associated with specific procedures. Results: Of 529 eligible patients, 511 agreed to participate, were enrolled, and completed the survey. Typical respondents were female (440 [86.1%]), 45 years or older (286 [56.0%]), white (386 [75.5%]), and college educated (469 [91.8%]) and had previously received at least 2 cosmetic procedures (270 [52.8%]). Apart from motivations pertaining to aesthetic appearance, including the desire for beautiful skin and a youthful, attractive appearance, motives related to physical health, such as preventing worsening of condition or symptoms (253 of 475 [53.3%]), and psychosocial well-being, such as the desire to feel happier and more confident or improve total quality of life (314 of 467 [67.2%]), treat oneself or celebrate (284 of 463 [61.3%]), and look good professionally (261 of 476 [54.8%]) were commonly reported. Motivations related to cost and convenience were rated as less important (68 of 483 [14.1%]). Most motivations were internally generated, designed to please the patients and not others, with patients making the decision to undergo cosmetic procedures themselves and spouses seldom being influential. Patients younger than 45 years were more likely to undertake procedures to prevent aging (54 of 212 [25.5%] vs 42 of 286 [14.7%] among patients ≥45 years; P < .001). Patients seeking certain procedures, such as body contouring (19 of 22 [86.4%]), acne scar treatment (36 of 42 [85.7%]), and tattoo removal (8 of 11 [72.7%]), were more likely to report psychological and emotional motivations. Conclusions and Relevance: This initial prospective, multicenter study comprehensively assessed why patients seek minimally invasive cosmetic procedures. Common reasons included emotional, psychological, and practical motivations in addition to the desire to enhance physical appearance. Differences relative to patient age and procedures sought may need further exploration.

Hyaluronic acid fillers: Restylane and Perlane.

The list of injectable skin fillers available for soft-tissue augmentation is constantly growing, giving aesthetic surgeons more options in the treatment of scars, lines, and wrinkles. Various products for soft-tissue augmentation are currently available in the United States based on hyaluronic acid. One should keep in mind that for these hyaluronic acid gel to have the desired longevity they must have repeating chemical bridges to withstand the constant mechanical and chemical enzymatic degradation to which they are subjected once implanted. Restylane and Perlane have proved to be safe, effective, and liked by patients. The Restylane family of products is currently expanding and soon practitioners will be able to have a diversified arsenal of cross-linked hyaluronic acid products to rejuvenate the aging face.

Dermal fillers: an update.

Injection of dermal fillers is the second most frequent nonsurgical cosmetic procedure performed in the USA. Dermal fillers are an option in the treatment of volume deficiency, scars, and rhytides; facial sculpting; facial contouring; and augmentation of specific anatomical sites such as the lips. The number of injectable dermal fillers available on the market increases yearly. Dermatologists and cosmetic surgeons should regularly review treatment options to provide patients with safe and effective filler options. This paper extensively reviews the properties of the available fillers, such as their rheology, longevity, and adverse effects, and how these properties affect the choice of filler agent for a particular patient or a particular site. Also, trends in dermal filler injections are discussed.

Long-term efficacy, safety and durability of Juvéderm® XC.

Over the last decade, there has been increasing interest in minimally invasive cosmetic treatments, especially for facial rejuvenation. Next to botulinum toxin injection, the injection of soft tissue fillers is the second most frequent minimally invasive procedure performed in the USA. Hyaluronic acid (HA) is the most commonly used dermal filler. One of patients' main concerns about filler injections pertains to pain and discomfort. Topical anesthetics, nerve blocks, and/or the incorporation of lidocaine to the filler have been applied in order to reduce distress and pain. Despite nerve blocks being an effective form of anesthesia, they may distort the area to be treated, as well as lengthen and complicate the procedure. Studies have shown that the incorporation of lidocaine to HA fillers significantly reduces pain and discomfort. Yet, one of the dilemmas about the addition of lidocaine solution to HA fillers is the possible alteration of the physical characteristics of the product by negatively impacting the efficacy and/or duration of the filler. The concern is that the addition of lidocaine could dilute the product, creating less correction per mL, changing the product's viscosity and consequently the "lifting" ability. Also, this dilution could reduce the product's duration. There may be a difference between a physician adding an aqueous solution into a lidocaine-free version of HA and the pre-incorporated lidocaine version of HA. An aqueous solution might dilute the product, while the pre-incorporated powder lidocaine appears to avoid this problem. Juvéderm® XC is manufactured with powder lidocaine 0.3%; it is associated with significantly less injection pain than Juvéderm® and other lidocaine-free versions of HA. Studies have shown that lidocaine enhances treatment comfort and optimizes the injection experience while maintaining a similar safety and effectiveness profile. Regarding the longevity, further study is necessary to determine if there is any difference in durability.

Cosmeceuticals: current trends and market analysis.

The desire to maintain a youthful image combined with an emerging global market with disposable income has driven the development of many new industries. The cosmeceutical industry is based on the development and marketing of products that lie between cosmetics and pharmaceuticals. Today, there are over 400 suppliers and manufacturers of cosmeceutical products, and the industry is estimated to grow by 7.4% by 2012. Although a number of products advertise predictable outcomes, the industry is largely unregulated and any consumers of cosmeceutical products should consult a dermatologist prior to use. This review will provide a snapshot of the current trends of this industry and provide an analysis of this multi-billion dollar market.

Hyaluronic acid gel fillers in the management of facial aging.

Time affects facial aging by producing cellular and anatomical changes resulting in the consequential loss of soft tissue volume. With the advent of new technologies, the physician has the opportunity of addressing these changes with the utilization of dermal fillers. Hyaluronic acid (HA) dermal fillers are the most popular, non-permanent injectable materials available to physicians today for the correction of soft tissue defects of the face. This material provides an effective, non invasive, non surgical alternative for correction of the contour defects of the face due to its enormous ability to bind water and easiness of implantation. HA dermal fillers are safe and effective. The baby-boomer generation, and their desire of turning back the clock while enjoying an active lifestyle, has expanded the popularity of these fillers. In the US, there are currently eight HA dermal fillers approved for commercialization by the Food and Drug Administration (FDA). This article reviews the innate properties of FDA-approved HA fillers and provides an insight on future HA products and their utilization for the management of the aging face.

Determination of the area of skin capable of being covered by the application of 250 mg of 5% imiquimod cream.

BACKGROUND: Five percent imiquimod cream is FDA-approved for the treatment of genital and perianal warts and actinic Keratosis. The manufacturer recommends that a single sachet containing 250 mg of 5% imiquimod cream (12.5 mg of imiquimod) is adequate for a single use and is sufficient to cover a wart area of up to 20 cm(2). OBJECTIVE: To determine the maximal area of skin that can be evenly covered by 250 mg of 5% imiquimod cream that is contained in one single-use sachet. METHODS: The contents of one 250-mg single-use sachet of 5% imiquimod cream were mixed with less than 1 mg of fluorescein sodium. The cream was applied evenly onto the abdomen of two Yorkshire female pigs and onto the medial and lateral aspects of the upper left arm of a human subject. The area of application was then measured. RESULTS: The average area obtained on the pig skin was 196 cm(2). The area covered on the human subject was 386 cm(2). CONCLUSION: We have found that one sachet of 250 mg of 5% imiquimod cream can be applied to an area of skin up to 386 cm(2). In light of the increasing use of 5% imiquimod cream in the treatment of cutaneous diseases, such as actinic keratoses, which affect larger areas of skin than genital warts, a more efficient use of 5% imiquimod cream may make this medication a more cost-effective treatment modality.