Effectiveness and Safety of Sculptra Poly-L-Lactic Acid Injectable Implant in the Correction of Cheek Wrinkles.

BACKGROUND: The current study evaluated the effectiveness and safety of Sculptra injectable poly-L-lactic acid (PLLA-SCA) treatment in correcting cheek wrinkles compared with a no-treatment control. METHODS: Male/female immune-competent adults (aged >21 years) with moderate/severe cheek wrinkles, graded using the Galderma Cheek Wrinkle Scale (GCWS) at rest, were randomized 2:1 to receive PLLA-SCA injections (150 mg; 8 mL reconstitution in sterile water for injection) + 1 mL lidocaine hydrochloride (2%), administered immediately after reconstitution, or no treatment (control). Up to 3 additional treatments were allowed at monthly intervals, and follow-up was at months 7, 9, and 12. The primary endpoint was 1-grade or greater improvement in GCWS at rest for both cheeks at month 12. RESULTS: GCWS at rest responder rate was significantly higher with PLLA-SCA treatment versus the no-treatment control at months 7 (66.2% versus 38.6%; P=0.0043), 9 (70.6% versus 31.1%; P<0.0001), and 12 (71.6% versus 26.1%; P<0.0001). Treating investigators reported improvements in skin radiance (>95%), tighter appearance (>88%), and jawline contour (>85%). PLLA-SCA recipients reported high satisfaction levels regarding improvements in skin radiance (90% or greater), sagging (84% or greater), and firmness (91% or greater) as well as natural-looking results (85% or greater) and a desire for repeat treatment (84% or greater). Treatment-related adverse events were mostly mild in severity with no serious events related to PLLA-SCA injections. CONCLUSION: Injectable PLLA-SCA treatments were well tolerated and significantly reduced the severity of moderate/severe cheek lines and wrinkles, while improving skin quality. Effectiveness was durable over the 12-month study period with high subject-reported satisfaction, natural-looking appearance, and enthusiasm for repeat treatments. CLINICALTRIALS: gov registry number: NCT04124692J Drugs Dermatol. 2024;23(1):1297-1305.        doi:10.36849/JDD.7729.

AbobotulinumtoxinA Treatment of Glabellar Lines Using a New Reconstitution and Injection Volume: Randomized, Placebo-Controlled Data.

BACKGROUND: Increasing the reconstitution and injection volumes of abobotulinumtoxinA (aboBoNT-A) could provide more options for aesthetic healthcare professionals. OBJECTIVE: To evaluate efficacy and safety of aboBoNT-A treatment of moderate-to-severe glabellar lines (GL) versus placebo, using a new reconstitution and injection volume. Methods & Materials: In this 6-month, Phase III, randomized, double-blind study, subjects 18-64 years were administered aboBoNT-A 50 U (N=224) or placebo (N=77), as five 0.1-mL-injections (10 U) in the glabellar region following reconstitution of a 300-U-vial in 3 mL. Assessments included time to onset of effect, investigator- (ILA) and subject- (SSA) assessed GL severity, subject satisfaction, aesthetic improvement and safety. The primary endpoint was composite 2-grade response at month 1 (a GL severity of none-or-mild at maximum frown and ≥2-grade improvement from baseline concurrently on both ILA and SSA). RESULTS: Median time to onset was 2 days, 34% of subjects reporting effect on day 1. At month 1, the composite 2-grade responder rate was 65.8% for aboBoNT-A versus 0% for placebo, P<0.001, 91–92% had none-or-mild GL severity, and 95–100% had a ≥1-grade GL severity improvement. A ≥1-grade improvement was sustained in 46-56% of aboBoNT-A-treated subjects up to 6 months (P<0.001 vs placebo). Aesthetic improvement and subject satisfaction were high throughout 6 months and aboBoNT-A treatment was well tolerated. CONCLUSION: Safety and efficacy of GL treatment using 0.1 mL (10 U) aboBoNT-A per injection site were demonstrated, with rapid onset and up to 6 months’ duration of effect. Severity improvement was accompanied by sustained aesthetic improvement and subject satisfaction. J Drugs Dermatol. 2021;20(9):988-995. doi:10.36849/JDD.6130.

Photodocumentation in skin of color.

Photodocumentation is an important tool utilized across medical specialties and plays an especially pivotal role in dermatology given the visual nature of the field. Although it has been well-established that dermatologic diseases manifest differently in dark skin compared to light skin, there is under-representation of images of dark skin in dermatology textbooks and other educational resources. It is essential for dermatologists to work toward increasing the availability of images of dermatologic disease in dark skin by improving their own ability to successfully photograph dark-skinned patients. In this article, we describe our nuanced approach to photographing skin of color in regards to the ideal background type, lighting, and camera settings.

Chart Review Presenting Safety of Injectable PLLA Used With Alternative Reconstitution Volume for Facial Treatments.

BACKGROUND: Since the approval of Sculptra Aesthetic, the amount of sterile water used to reconstitute the product has gradually increased in clinical practice. A retrospective chart review was conducted to evaluate patient safety associated with a larger reconstitution volume, and to investigate specific parameters for how Sculptra Aesthetic is used in a real-world clinical setting. OBJECTIVE: The primary objective of the study was to evaluate the safety of Sculptra Aesthetic when using a reconstitution volume of 7 to 10 mL, via collection of adverse events related to the product or injection procedure reported in medical records. METHODS: This was a multi-center, retrospective chart review conducted in the US. Medical records for subjects treated in the facial area with Sculptra Aesthetic reconstituted to 7–10 mL were reviewed to obtain information about demographics, treatment data, and adverse events. Each injector completed a questionnaire regarding reconstitution and injection procedures generally used. RESULTS: There were 4483 treatments performed in 1002 subjects; nearly half (48%) had 3 or 4 treatments during the studied period. Subjects most commonly received treatment in the midface/cheek area (97%), temple (94%), and jawline (54%). All injectors indicated adding lidocaine to the solution, resulting in total volumes of 8–10 mL. Adverse events were reported by 3.6% of subjects, all mild in intensity. Nodules were reported by 4 subjects (0.4%). CONCLUSION: The low number of AEs reported in this retrospective chart review suggests that facial aesthetic treatment with PLLA reconstituted to a final volume of 8–10 mL, including anesthetics, is associated with a favorable risk benefit ratio. J Drugs Dermatol. 2021;20(1):18-22. doi:10.36849/JDD.5631.

Treatment of Acne Scars With High Intensity Focused Radio Frequency.

In this multi-site case series, the efficacy of high intensity focused radiofrequency (RF) delivered to the dermis was evaluated for treating acne scars. A novel delivery system that uses insulated microneedles to deliver a desired thermal effect to multiple depths of the dermis while sparing the epidermis from RF injury was used. Four (4) healthy subjects from four different practices were evaluated and used in this case report. The subjects were treated between 3 or 4 times depending on the severity of the acne scars presented. The depth of thermal delivery was adjusted before each pass and all subjects received at a minimum, three passes to the treated area. Before and after photographs along with adverse effects were recorded. The theory behind the use of insulated needles with the active RF delivery at the distal tip is to allow for significant thermal injury to several layers of the dermis while avoiding thermal injury to the epidermis. This case report demonstrates significant improvement on acne scars and that all skin types should be safely treatable with minimum downtime realized.

The Potential Role of Topically Applied Heparan Sulfate in the Treatment of Photodamage.

Heparan sulfate is an essential glycosaminoglycan that plays important roles in development, homeostasis, and disease. As a group, the glycosaminoglycans provide mechanical strength to skin, as they can absorb water and occupy the space between elastin fibers and collagen. Heparan sulfate is also a key participant in cell proliferation, cell migration, collagen fiber formation, basement membrane regeneration, granulation tissue formation, and cell adhesion associated with wound healing. A variety of dermatological disorders are associated with changes in glycosaminoglycans or their associated proteoglycans. A new topical formulation of low molecular weight heparan sulfate glycosaminoglycan has been shown to penetrate the epidermis, basement membrane, and dermis within 24 hours of application. In an 8-week study, 15 patients using this new formulation showed improvement in skin hydration, skin firmness, skin elasticity, skin barrier function, and global fine lines and wrinkles. Incorporating low molecular weight heparan sulfate into topically applied formulations may represent a new approach to improving the appearance of photodamaged skin.

The skin health and beauty pyramid: a clinically based guide to selecting topical skincare products.

The use of cosmeceuticals by patients is now commonplace. Without consultation and direction from an informed clinician, marketing pressures can lead consumers to make poor product choices that can result in wasted money and unsatisfactory outcomes. Skin professionals need a scientifically based, succinct tool to guide their patients toward best topical skincare practices. The Skin Health and Beauty Pyramid is an educational framework and product guide created from extensive scientific literature and study review on ingredients, formulations and technologies affecting skin biology. This clinical tool can simplify product choices for physicians and clinicians in the process of professionally guiding patients toward the optimal use of topical products to achieve best outcomes for skin health and beauty.

Prospective, multicenter study to determine the safety and efficacy of a unique radiofrequency device for moderate to severe hand wrinkles.

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 (Pellevé 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.

Multiple facial burns with the new Thermage CPT system.

A 45-year-old man requested treatment with Thermage for skin tightening. He was treated with the new Thermage CPT system and received several facial burns due to failure of the dielectric membrane. It may be contraindicated to treat male patients with this system.

Retrospective analysis of pimecrolimus cream 1% for treatment of facial vitiligo.

OBJECTIVE: To explore the effectiveness of pimecrolimus cream 1% used twice daily (BID) for the treatment of facial vitiligo. METHODS: Patients who had used pimecrolimus cream 1% monotherapy BID for at least 3 months and who had photographs taken at baseline and after initiation of therapy were analyzed in a retrospective study. The total affected surface area (cm2) of facial vitiligo in the baseline and follow-up photographs was compared. The extent of facial depigmentation was scored using a 7-point scale (0 = no disease to 6 = 100% involvement). RESULTS: Eight patients met study entry criteria. Mean time from initiation of treatment to the final follow-up visit was 11 months (SD +/- 7.5 months). Mean affected surface area at baseline and follow-up were 79.40 cm2 and 17.96 cm2, respectively, (P = .012) with a mean percent improvement 72.5% (SD +/- 20.4%). Mean depigmentation score decreased from 2.8 at baseline to 1.4 at follow-up. No adverse events were reported. CONCLUSION: Pimecrolimus cream 1% may be a viable alternative to current therapies for the treatment of facial vitiligo.

Skin tightening with a combined unipolar and bipolar radiofrequency device.

Monopolar radiofrequency (RF) devices are well established treatment modalities for tightening facial skin. A 60-year-old woman presented with a desire to tighten the lax skin and improve the appearance of both upper arms. A combination unipolar and bipolar RF device may provide volume reduction as well as skin tightening in the upper arm.

Evaluation of the multiple pass, low fluence algorithm for radiofrequency tightening of the lower face.

BACKGROUND AND OBJECTIVE: Non-ablative monopolar radiofrequency technology delivers heat to the deep dermis and subdermal layers of the skin to improve facial laxity. The purpose of this study is to evaluate the multiple pass, low fluence treatment algorithm for lower face laxity. STUDY DESIGN/MATERIALS AND METHODS: Sixty-six subjects with moderate facial laxity were treated with a maximum of 5 passes over the lower face and neck. Treated areas were evaluated using the Leal Laxity Classification System and by independent photographic assessment. Measurements of skin stiffness and energy absorption were taken with the BTC2000 device. RESULTS: The average treatment level was 62.0 (83 J/cm(2)) with 556 pulses per treatment. At the 6 month follow-up visit, 92% of patients had a measurable improvement in overall appearance. Independent photographic review revealed improvement in 84% of subjects at 6 months. Objective measures utilizing the BTC2000 device demonstrated improvement that diminished with time. CONCLUSION: The low-fluence, multiple pass technique is an effective algorithm for radiofrequency skin tightening.

Modeling the highly specific ribotoxin recognition of ribosomes.

The three-dimensional structures of the alpha-sarcin ribotoxin and its delta(7-22) deletion mutant, both complexed with a 20-mer oligonucleotide mimicking the sarcin/ricin loop (SRL) of the ribosome, have been docked into the structure of the Halobacterium marismortui ribosome by fitting the nucleotide atomic coordinates into those of the ribosomal SRL. This study has revealed that two regions of the ribotoxin, residues 11-16 and 84-85, contact the ribosomal proteins L14 (residues 99-105) and L6 (residues 88-92), respectively. The first of these two ribotoxin regions appears to be crucial for its specific ribosome recognition.