Efficacy and Tolerability of HydraFacial Clarifying Treatment Series in the Treatment of Active Acne Vulgaris.

Objective: This 12-week, multicenter, open-label study investigated the efficacy and tolerability of the HydraFacial Clarifying Treatment for improving skin appearance in patients who present with acne vulgaris. Methods: Twenty eligible adult patients with mild-to-moderate acne were enrolled at one of two treatment sites in the United States and were to undergo six HydraFacial Clarifying Treatments, one every two weeks for 12 weeks. Treatment occurs in three steps: cleansing and peeling; suction to extract dead skin cells, sebum, and debris; and application of blue LED light. Acne severity was graded by investigators and by patients using the Global Acne Severity Score (GASS). Results: The proportion of patients with no acne or almost clear skin (GASS ≤1) at baseline versus final treatment increased from 20 to 65 percent per investigator assessment (p=0.0027), and from 5 to 55 percent per patient self-report (p=0.0016). At final treatment, more than 80 to 100 percent of both investigators and patients agreed or strongly agreed there was an improvement in skin appearance across multiple assessment parameters. Treatments were generally well tolerated. Limitations: Due to the nature of the treatment, blinding of neither investigators nor patients was feasible. Conclusion: The results presented here suggest that a series of six HydraFacial Clarifying Treatments improves overall skin appearance in patients with active acne.

The Anti-Aging Effects of Low Oxygen Tension Generated Multipotent Growth Factor Containing Serum.

Growth factors are a new category of ingredient found in modern cosmeceutical formulations. One novel method of obtaining cosmeceutical growth factors is the use of a bioreactor to culture neonatal broblasts on dextran microcarrier beads for 8 weeks under low oxygen tension (1-5%) mimicking embryonic conditions and eliminating the need for fetal bovine serum constituents in the final cosmetic material. This research evaluated the ingredient in a moisturizing vehicle on 40 females to determine its efficacy in improving overall facial skin appearance, as well as skin brightness, evenness, firmness, pore size, radiance, fine lines, coarse wrinkles, and blotchiness/ dispigmentation. Statistically significant improvement was seen in 90 days in skin hydration through corneometry, as well in global investigator and subject assessments. J Drugs Dermatol. 2017;16(1):30-34..

Evaluation of the in vivo effects of various laser, light, or ultrasound modalities on human skin treated with a collagen and polymethylmethacrylate microsphere dermal filler product.

BACKGROUND: Bellafill® is a soft tissue dermal filler composed of non-resorbable polymethylmethacrylate (PMMA) microspheres, suspended in a water-based carrier gel composed of 3.5% bovine collagen. It has been approved by the FDA for the correction of nasolabial folds and atrophic facial acne scars. Energy-based therapies are used for facial rejuvenation and treatment of acne scarring. However, little has been published about the effects of energy devices on previously placed PMMA. This prospective, in vivo clinical study evaluated the safety and histopathological effects of a number of different laser, light, and ultrasound treatment modalities on PMMA-collagen filler previously injected into human tissue. METHODS: Following a negative reaction to the bovine collagen skin test, the abdomen of one subject (with planned mini-abdominoplasty) was divided into a grid with 32 treatment sections. Seventeen treatment areas received subdermal injections of PMMA-collagen product (0.1-0.2 cc in each area). The subject was assessed for adverse events at each post-treatment office visit. Eighty days post-injection, 30 treatment sections were treated with laser, light, or ultrasound therapy (16 of the 17 PMMA-collagen treated areas, with two of those areas receiving a combination of therapies, and an additional 14 areas receiving laser therapy alone). One PMMA-collagen treated area was not exposed to any energy devices, and one remaining treatment area received no treatment of any kind, representing an internal control. Sixty days following energy device treatment, the tissue was excised in a planned mini-abdominoplasty procedure and sent for histological examination. RESULTS: The subject experienced no adverse events during the study. No histological changes in PMMA microspheres were observed in any treatment area. An expected lymphohistiocytic response was identified in all areas where PMMA microspheres were present. CONCLUSION: Laser, light, and ultrasound treatments can safely be administered following a PMMA-collagen injection. Lasers Surg. Med. 48:811-819, 2016. © 2016 Wiley Periodicals, Inc.

Pilot, Multicenter, Open-Label Evaluation of Safety, Tolerability and Efficacy of a Novel, Topical Multipotent Growth Factor Formulation for the Periorbital Region.

BACKGROUND: This multicenter, open-label pilot study evaluated safety, efficacy and tolerability of a topical formulation containing a multipotent growth factor resignaling complex (MRCx), when applied to infraorbital and lateral canthal skin. METHODS: Thirty-nine female subjects with mean age of 56.8 years who had periorbital lines and wrinkles, uneven skin texture, puffiness, and lack of skin firmness were enrolled, and 38 completed the study. All subjects applied the multipotent growth factor formulation bilaterally to the periorbital area, twice daily for 60 days. Efficacy and treatment-related adverse events were evaluated at Baseline and days 14, 30, and 60. Investigators rated the periorbital areas based on 10-point scales. RESULTS: Subjects' self-reported compliance with treatment was greater than 99% throughout the study. At day 60, all subjects had improvement in infraorbital brightness (≥ 2 points), moistness (≥ 2 points), wrinkles (≥ 1 point), sallowness (≥ 1 point), crepiness (≥ 1 point), smooth texture (≥ 1 point), skin tightness (≥ 1 point), and skin tone (≥ 1 point). Investigator-rated assessments showed ≥ 1-point improvement for lateral canthal wrinkles, dyschromia/mottled pigmentation, skin tone, overall brightness, and moistness. Investigator-rated scoring on the Global Aesthetic Improvement Scale (GAIS) demonstrated that 67.6% of subjects were much improved/improved at day 14, and 63.1% remained improved at day 60. Overall, 76.2% and 79.0% of subjects were very pleased/pleased/mostly pleased with the appearance of their infraorbital and lateral canthal areas at day 60. Adverse events comprised one case of mild canthal erythema, and one case of mild eye irritation, both of which were respectively resolved. CONCLUSIONS: This pilot study demonstrated that the topical multipotent growth factor formulation was safe, effective and well tolerated for periorbital skin rejuvenation.

Five-Year Safety and Satisfaction Study of PMMA-Collagen in the Correction of Nasolabial Folds.

BACKGROUND: A polymethylmethacrylate-collagen filler is generally believed to give long-term benefits, but the risk of granuloma formation over time remains unclear. OBJECTIVE: To determine the incidence of granuloma formation and response to treatment and assess the degree of patient satisfaction over 5 years. MATERIALS AND METHODS: Adults seeking correction of nasolabial folds underwent up to 3 injection sessions over 2 months. Subjects were then queried regularly for the development of signs and symptoms of a granuloma. Any positive responses were evaluated, and lesions suspicious for granulomas were confirmed by biopsy. Granulomas were treated at the discretion of the investigator. Subjects also completed regular satisfaction questionnaires. RESULTS: A total of 1,008 subjects were enrolled and 871 completed the full 5 years of the study. A biopsy-confirmed granuloma developed in 1.7% of subjects. Almost all granulomas responded to treatment. At study exit, 0.9% of subjects had an unresolved granuloma. Patient satisfaction remained high throughout the duration of the study. CONCLUSION: The incidence of granuloma formation with a polymethylmethacrylate-collagen dermal filler is low, and almost all lesions are manageable with simple therapeutic measures. Patient satisfaction remains durable over 5 years. Polymethylmethacrylate-collagen offers a well-characterized and very favorable risk/benefit profile.

Safety and effectiveness of focused cold therapy for the treatment of hyperdynamic forehead wrinkles.

BACKGROUND: Approximately 25% of patients exploring treatments for wrinkle reduction, have reservations about toxins. Therefore, a nonsurgical, minimally invasive, and toxin-free approach to eliminate facial hyperdynamic lines is desirable. OBJECTIVE: To assess the clinical safety and effectiveness of focused cold therapy (FCT) for the reduction of hyperdynamic forehead wrinkles. METHODS: Forty-one subjects received FCT to temporal branches of the facial nerve. Hyperdynamic forehead wrinkles were assessed by the investigator and subject before treatment, immediately after procedure, and at 7, 30, 60, 90, and 120 days after treatment. A validated 5-point wrinkle scale and a 9-point global improvement scale were used to measure line severity. RESULTS: Five subjects received a lower treatment dose and were therefore excluded from analysis. In the remaining 36 subjects, 91% had at least a 1-point improvement in forehead line severity at 30 days after treatment and 70% had at least a 2-point improvement. There were no serious adverse events. CONCLUSION: Subjects treated for forehead wrinkles showed significant clinical improvement with high subject satisfaction and no serious adverse events. Focused cold therapy seems to be an effective, safe nontoxic alternative to popular wrinkle-reducing treatments.

Anti-aging proof of concept study: results and summary.

BACKGROUND AND OBJECTIVES: The etiology of aging human skin includes intrinsic physiologic changes greatly accelerated by photoaging, predominantly through exposure to UV light. Consumer interest and demand for anti-aging skin care products is extremely high especially in light of aging populations. Prenatal (fetal) tissue has been shown to possess healing characteristics and regenerative effects. A proprietary tissue engineering technology has been developed to produce a soluble human extracellular matrix material with growth factors and proteins. Neonatal cells are cultured on microbeads under conditions of low oxygen tension. This human cell-conditioned media (hCCM) contains a variety of growth factors and cytokines similar to those found in fetal cells and has been incorporated into a topical preparation for use in facial wound healing (after laser resurfacing procedures) and improving the appearance of aging skin. The objective of this study was to observe the effects of an MRCx™-containing topical skincare regimen on subjects with demonstrated aging skin damage (photodamage) when used consistently over a 3 month time period. METHODS: Female subjects age 35-65 with Fitzpatrick Skin Type I-IV and mild to moderate amounts of photodamage, fine lines, and wrinkles used Regenica® Replenishing Crème and Regenica® Renew SPF 15 for 3 months. At each visit, photos were taken of subjects while investigators completed skin grading assessments and subjects completed self-assessments. Investigator assessments included evaluation of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance, and translucence on a 5-point scale. Subjects' self-assessments included assessment of fine lines and wrinkles, firmness, evenness of skin tone, brightness, resilience, clarity, and radiance. Changes from baseline were evaluated for each parameter and P values for changes from baseline to each study visit for investigator's assessments and to end-of-study for self-assessments were calculated. RESULTS: Eighteen of 21 enrolled female subjects completed the study. Three subjects chose to drop from the study. Statistically significant improvements in investigator assessments of tactile roughness, visual texture, wrinkles, blotchiness, skin tone evenness, radiance and translucency compared to baseline were observed at weeks 4, 8, and 12 after initiating treatments. Progressive improvement was seen through the last study visit (visit 5, week 12). Similar statistically significant improvements in subjects' self-assessments were seen comparing the first post-baseline visit (visit 2, week 2) to subsequent visits. 93.5 % subjects agreed (somewhat or strongly) with all of the positive subject assessment statements at week 12. Importantly, 100 % of subjects indicated at the end of the study that they would recommend the product to a friend and would want to purchase the product. No treatment-related adverse events were recorded during the study. CONCLUSIONS: Regenica was safe and clinically effective in reducing anti-aging effects in this group of female subjects aged 35-65 years as measured by both investigator assessments and subjects' self-assessments.

A double-blind, randomized, multicenter, controlled trial of suspended polymethylmethacrylate microspheres for the correction of atrophic facial acne scars.

BACKGROUND: Acne scarring remains a stubborn clinical problem. Few treatments have been shown to be definitely effective for this problem. Polymethylmethacrylate (PMMA) microspheres in collagen (ArteFill, Suneva Medical Inc, Santa Barbara, CA) have shown long-term benefit for nasolabial fold treatment. A pilot study has shown benefit for PMMA-collagen in atrophic acne scarring. OBJECTIVE: We sought to demonstrate the safety and effectiveness of PMMA-collagen for acne scarring in a controlled, blinded trial. METHODS: Subjects with at least 4 moderate to severe rolling, atrophic scars randomly received PMMA-collagen or saline injections. Subjects underwent up to 2 injection sessions and were followed up for 6 months. Efficacy was assessed using a validated rating scale for each scar. RESULTS: In all, 147 subjects underwent injections. Success was achieved by 64% of those treated with PMMA-collagen compared with 33% of control subjects (P = .0005). The treatment showed excellent safety with generally mild, reversible adverse events. No significant differences in efficacy or safety were noted between genders, for darker skin types, or in older age groups. LIMITATIONS: Subjects were followed up for only 6 months. CONCLUSION: PMMA-collagen demonstrates substantial effectiveness in the treatment of atrophic acne scars of the face while maintaining an excellent safety profile. Further follow-up should be undertaken to demonstrate longer-term benefit and safety.

Does experience matter? A comparison of the practice of attendings and residents.

OBJECTIVE: To compare the utilization of health care resources and patterns of chronic disease care by patients of medical residents and patients of their attending physicians. MATERIALS AND METHODS: This study involved a longitudinal cohort of 14,554 patients seen over a 1-year period by 149 residents and 36 attendings located in an urban academic medical center. Data were acquired prospectively through a practice management system used to order tests, write prescriptions, and code ambulatory visits. We assessed resource utilization by measuring the total direct costs of care over a 1-year period, including ambulatory and inpatient costs, and the numbers and types of resources used. RESULTS: Residents' patients were similar to attendings' patients in age and gender, but residents' patients were more likely to have Medicaid or Medicare and to have a higher burden of comorbidity. Total annual ambulatory care costs were almost 60% higher for residents' patients than for attendings' patients in unadjusted analyses, and 30% higher in analyses adjusted for differences in case mix (adjusted mean 888 dollars vs 750 dollars; P=.0001). The primary cost drivers on the outpatient side were consultations and radiological procedures. Total inpatient costs were almost twice as high for residents' patients compared to attendings' patients in unadjusted analyses, but virtually identical in analyses adjusted for case mix differences (adjusted mean of 849 dollars vs 860 dollars). Admission rates were almost double for residents' patients. Total adjusted costs for residents' patients were slightly, but not significantly, higher than for attendings' patients (adjusted mean 1,651 dollars vs 1,540 dollars; P>.05). Residents' and attendings' patients generally did not differ in the patterns of care for diabetes, asthma/chronic obstructive pulmonary disease (COPD), congestive heart failure, ischemic heart disease, and depression, except that residents' patients with asthma/COPD, ischemic heart disease, and diabetes were admitted more frequently than attendings' patients. CONCLUSIONS: Our results indicate that residents' patients had higher costs than attendings' patients, but the differences would have been seriously overestimated without adjustment. We conclude that it costs about 7% more for residents to manage patients than for attendings. On the ambulatory side, the larger number of procedures and consults ordered for residents' patients appears to drive the higher costs.