Real-World, Open-Label Study of the Efficacy and Safety of a Novel Serum in Androgenetic Alopecia.

Pattern-type hair loss is a highly prevalent condition affecting the majority of men and women at some point in their lifetime. Although genetics and androgens are instrumental in the pathogenesis of this type of hair loss, it is increasingly recognized that inflammation, stress, and environmental factors play a central role. The few and widely used monotherapies approved by the US Food and Drug Administration, such as minoxidil or finasteride, are not efficacious in all people and cause adverse events that prevent patient compliance. Therefore, new treatments that are easy to use and that holistically address the multi-factorial pathophysiology of pattern-type hair loss are needed. Clinical studies have already demonstrated the safety and efficacy of a plethora of bioactive natural products, such as epigallocatechin gallate (EGCG), Vitis vinifera seed extract, Glycyrrhiza root extract, apigenin, and saw palmetto extract to name a few, in improving hair follicle homeostasis via anti-inflammatory, anti-androgen, anti-microbial, and anti-oxidant action. Here, we present a novel topical serum, REVIVV®, that contains a proprietary blend of phytochemicals designed to stimulate hair growth, reduce shedding, and restore homeostasis to the hair follicle. The serum’s safety and efficacy were assessed in 150 participants in a real-world clinical setting. Findings demonstrate that twice-daily use of the serum significantly improves hair growth, and reduces shedding after 8 weeks of use. All participants rated the serum as easy to use and stated plans for continued use. Overall, the topical serum REVIVV® showed evidence of good efficacy related to hair growth and had positive cosmetic properties warranting further evaluation in clinical studies. Rapaport J, Sadgrove NJ, Arruda S, et al. Real-world, open-label study of the efficacy and safety of a novel serum in androgenetic alopecia. J Drugs Dermatol. 2023;22(6):559-564. doi:10.36849/JDD.7403.

Subject satisfaction following treatment with nanofractional radiofrequency for the treatment and reduction of acne scarring and rhytids: A prospective study.

BACKGROUND: Skin-related changes, such as fine lines, wrinkles, and acne scarring, are a source of distress to both men and women. Nanofractional radiofrequency delivers thermal energy to skin layers leading to dermal remodeling that can address skin conditions related to aging. The objective of this study was to evaluate the subject satisfaction of nanofractional radiofrequency for the treatment of facial wrinkles and acne scarring in both lighter and darker skin tones. MATERIALS AND METHODS: 30 subjects (skin types II-VI) were enrolled in this prospective, evaluator-blind study. The average age of subjects was 51.9 ± 13.5 years. Subjects received three treatments at 3- to 5-week intervals on both sides of the face using the 80- or the 160-pin tip disposables. Follow-up visits were conducted at 6- and 12 weeks after the last treatment. Subject satisfaction was evaluated using a self-assessment of a reduction of wrinkles or acne scars, and subject satisfaction questionnaire. Pain, tolerability, and safety were monitored throughout. RESULTS: Subjects treated for acne or wrinkles were satisfied with their treatment at both the 6-week and 12-week follow-up visit (mean score 3.0; range 0 = very unsatisfied to 4 = very satisfied). The treatments were well tolerated at all treatment sessions, averaging a score of 3.5 on the tolerability scale (0 = very intolerable to 4 = very tolerable) with treatment-associated pain reported to be mild (3.2 out of 10). There were no adverse events or unanticipated side effects. CONCLUSIONS: This clinical study demonstrates subjects are satisfied with nanofractional radiofrequency treatments for improvement of their wrinkles and acne scars.

Randomized, Double-Blind, Placebo-Controlled Study of Poly-L-Lactic acid for Treatment of Cellulite in the Lower Extremities.

BACKGROUND: Poly-l-lactic acid (PLLA) is an injectable volumizer with biostimulatory properties used for volumetric structural rejuvenation in patients with facial fat volume loss but has increasingly been utilized for off-face applications. OBJECTIVE: The objectives of this randomized, double-blind, placebo-controlled single center study was to assess the safety and effectiveness of PLLA for the treatment of lower extremity cellulite in adult women. METHODS: 31 healthy women were enrolled in the study. Eligible subjects received 3 treatments every 4 weeks with either PLLA (treatment group) or saline (control group) injections combined with subcision, into each of the glutes or thighs. Follow-up visits were at 1, 3, and 6 months after treatment. Assessments included live ratings, rating of standardized pictures by a blinded evaluator, patient questionnaires, safety, and tolerability ratings. RESULTS: At the 3 and 6-month follow-up, there was a statistically significant change in the global aesthetic improvement scale (GAIS) compared to baseline as assessed by blinded investigators. Significant improvements were shown in the cellulite severity scale (CSS) as well as in the subject satisfaction questionnaires. Treatments were found to be tolerable, and no severe treatment-related adverse events occurred. CONCLUSION: Repeated PLLA treatments combined with subcision are effective and safe in improving the appearance of cellulite. J Drugs Dermatol. 20(5): doi:10.36849/JDD.5380.

Comparison of adverse events rates and hospital cost between customized individually made implants and standard off-the-shelf implants for total knee arthroplasty.

BACKGROUND: This study compares selected hospital outcomes between patients undergoing total knee arthroplasty (TKA) using either a customized individually made (CIM) implant or a standard off-the-shelf (OTS) implant. METHODS: A retrospective review was conducted on 248 consecutive TKA patients treated in a single institution, by the same surgeon. Patients received either CIM (126) or OTS (122) implants. Study data were collected from patients' medical record or the hospital's administrative billing record. Standard statistical methods tested for differences in selected outcome measures between the 2 study arms. RESULTS: Compared with the OTS implant study arm, the CIM implant study arm showed significantly lower transfusion rates (2.4% vs 11.6%; P = .005); a lower adverse event rate at both discharge (CIM 3.3% vs OTS 14.1%; P = .003) and 90 days after discharge (CIM 8.1% vs OTS 18.2%; P = .023); and a smaller percentage of patients were discharged to a rehabilitation or other acute care facility (4.8% vs 16.4%; P = .003). Total average real hospital cost for the TKA hospitalization between the 2 groups were nearly identical (CIM $16,192 vs OTS $16,240; P = .913). Finally, the risk-adjusted per patient total cost of care showed a net savings of $913.87 (P = .240) per patient for the CIM-TKA group, for bundle of care including the preoperative computed tomography scan, TKA hospitalization, and discharge disposition. CONCLUSIONS: Patients treated with a CIM implant had significantly lower transfusion rates, fewer adverse event rates, and were less likely to be discharged to a rehabilitation facility or another acute care facility. These outcomes were achieved without increasing costs.