Effectiveness and Safety of a New Hyaluronic Acid Injectable for Augmentation and Correction of Chin Retrusion.

BACKGROUND: A hyaluronic acid (HA) filler intended for non-surgical improvement of chin appearance should ideally be of high strength/firmness (high G') to allow for deep injections on the bone. HASHA (Restylane Shaype) is a new hyaluronic acid (HA) injectable with high G' and high HA concentration (25 mg/mL), engineered by the new NASHA-HD (High Definition) technology. HASHA is suitable to be placed periosteally, aiming to mimic the natural shape of the bony chin. This pivotal clinical investigation evaluated effectiveness and safety of HASHA for augmentation and correction of chin retrusion.  Methods: Subjects 18 years or older with mild or moderate chin retrusion by the Galderma Chin Retrusion Scale (GCRS), were randomized 3:1 to HASHA (n=103) or no treatment (n=37). Assessments included GCRS (blinded evaluator), aesthetic improvement (Global Aesthetic Improvement Scale [GAIS]), subject satisfaction, and safety.  Results: GCRS responder rate (1-grade or greater improvement from baseline) was significantly higher for HASHA (83.3%) versus controls (10.8%) at month 3 (P<0.001) and maintained through month 12 (P<0.001). Aesthetic improvement was high throughout the study in the HASHA group, according to investigators (97% or greater) and subjects (89% or greater). Overall, subject satisfaction was high at month 3 and maintained at month 12. Product- or injection-related adverse events were mostly mild or moderate and transient. No product- or injection-related serious adverse events were reported. CONCLUSIONS: HASHA, a new NASHA-HD injectable with extra strength/firmness, was safe and effective for chin augmentation and correction of chin retrusion, with high aesthetic improvement and subject satisfaction throughout 12 months. J Drugs Dermatol. 2024;23(4):255-261.     doi:10.36849/JDD.8145.

Skin care and hygiene among healthcare professionals during and after the SARS-CoV-2 pandemic.

The severe acute respiratory syndrome coronavirus 2 pandemic has necessitated enhanced protection against viral transmission among healthcare professionals, particularly relating to handwashing and personal protective equipment. Some of these requirements may persist for years to come. They bring associated concerns around skin hygiene and general care, with damage to the face and hands now a well-documented consequence among healthcare professionals. This review assesses optimal skin care during the severe acute respiratory syndrome coronavirus 2 pandemic and in the "new normal" that will follow, identifies current knowledge gaps, and provides practical advice for the clinical setting. Regular, systematic hand cleaning with soap and water or an alcohol-based hand rub (containing 60%-90% ethanol or isopropyl alcohol) remains essential, although the optimal quantity and duration is unclear. Gloves are a useful additional barrier; further studies are needed on preferred materials. Moisturization is typically helpful and has proven benefits in mitigating damage from frequent handwashing. It may be best practiced using an alcohol-based hand rub with added moisturizer and could be particularly important among individuals with pre-existing hand dermatoses, such as psoriasis and eczema. Face moisturization immediately prior to donning a mask, and the use of dressings under the mask to reduce friction, can be helpful dermatologically, but more work is required to prove that these actions do not affect seal integrity. Nonetheless, such measures could play a role in institutional plans for mitigating the dermatologic impact of transmission control measures as we exit the pandemic.

Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo.

BACKGROUND: Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A in clinical development. It is formulated with a proprietary peptide and offers the potential of a longer acting neurotoxin therapy. OBJECTIVE: To compare the safety, efficacy, and duration of response of daxibotulinumtoxinA with onabotulinumtoxinA and placebo [www.clinicaltrials.gov NCT02303002]. METHODS: In this Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Glabellar line severity was evaluated by investigators and subjects at least every 4 weeks, for at least 24 weeks. RESULTS: Overall, 268 subjects enrolled. Statistical and clinical superiority were observed for 40U and 60U daxibotulinumtoxinA over 20U onabotulinumtoxinA for a range of efficacy outcomes despite the study not being powered to detect statistically significant differences between these active treatment groups. CONCLUSION: The 40U dose of daxibotulinumtoxinA was well tolerated (e.g., absence of ptosis) and had the most favorable risk: benefit profile. Compared with 20U onabotulinumtoxinA, it exhibited a significantly greater response rate and a significantly longer duration of response (median of 24 weeks vs 19 weeks; p = .030).

Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines: Additional Analyses From a Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Study.

BACKGROUND: Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A. Published Phase 2 data show that, compared with 20U onabotulinumtoxinA, 40U daxibotulinumtoxinA is associated with a significantly greater response rate and significantly longer duration of response (median 24 weeks), and appears generally safe and well tolerated (www.clinicaltrials.gov NCT02303002). OBJECTIVE: To evaluate whether these efficacy and safety findings are influenced by baseline glabellar line severity. MATERIALS AND METHODS: In the Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Efficacy was evaluated by investigators for ≥24 weeks. RESULTS: Data from the per protocol population (n = 191) stratified by baseline glabellar line severity (125 moderate, 66 severe) suggest that the clinical advantage of 40U daxibotulinumtoxinA over 20U onabotulinumtoxinA is maintained for a range of efficacy outcomes regardless of whether glabellar lines are moderate or severe at baseline. Statistical evaluations were not completed due to the limited size of each subgroup. CONCLUSION: 40U daxibotulinumtoxinA appears to offer a clinical efficacy advantage over 20U onabotulinumtoxinA in both moderate and severe glabellar lines-with a greater advantage observed in severe glabellar lines.

Subject satisfaction with onabotulinumtoxinA treatment of glabellar and lateral canthal lines using a new patient-reported outcome measure.

BACKGROUND: Patient satisfaction with treatment is an important outcome in facial aesthetic medicine. OBJECTIVE: To evaluate subject satisfaction with onabotulinumtoxinA treatment of glabellar lines (GL) and crow's feet lines (CFL) using the validated Facial Line Satisfaction Questionnaire (FLSQ). METHODS: In this randomized double-blind study, subjects with moderate/severe GL and CFL received onabotulinumtoxinA (20 U, GL; 24 U, CFL) or placebo. Over 120 days, the following were assessed: satisfaction, achievement of treatment expectations, satisfaction with duration of treatment (FLSQ), severity of GL and CFL (Facial Wrinkle Scale [FWS]), and aesthetic improvement (Global Aesthetic Improvement Scale). RESULTS: Satisfaction in the per-protocol population was significantly greater at Day 60 in the onabotulinumtoxinA group (n = 60) compared with placebo (n = 57) for GL (81.7% vs 0%; p < .001). Most subjects treated with onabotulinumtoxinA remained satisfied up to 120 days. Achievement of treatment expectations (86.7%; Day 60), satisfaction (81.7%; Day 60), and satisfaction with the duration of treatment (61.6%; Day 90) were significantly better with onabotulinumtoxinA than placebo (p < .001) for GL and CFL combined. Efficacy (FWS) and aesthetic improvement were observed in most subjects at Days 30 and 60, respectively. CONCLUSION: High satisfaction rates are achieved and sustained in subjects treated with onabotulinumtoxinA for GL and CFL combined.

The evolving role of hyaluronic acid fillers for facial volume restoration and contouring: a Canadian overview.

Recent advancements, including more versatile facial fillers, refined injection techniques and the adoption of a global facial approach, have contributed to improved patient outcome and increased patient satisfaction. Nine Canadian specialists (eight dermatologists, one plastic surgeon) collaborated to develop an overview on volume restoration and contouring based on published literature and their collective clinical experience. The specialists concurred that optimal results in volume restoration and contouring depend on correcting deficiencies at various layers of the facial envelope. This includes creating a foundation for deep structural support in the supraperiosteal or submuscular plane; volume repletion of subcutaneous fat compartments; and the reestablishment of dermal and subdermal support to minimize cutaneous rhytids, grooves and furrows. It was also agreed that volume restoration and contouring using a global facial approach is essential to create a natural, youthful appearance in facial aesthetics. A comprehensive non-surgical approach should therefore incorporate combining fillers such as high-viscosity, low-molecular-weight hyaluronic acid (LMWHA) for structural support and hyaluronic acid (HA) for lines, grooves and furrows with neuromodulators, lasers and energy devices.

Pathway to dry skin prevention and treatment.

BACKGROUND: This article presents an evidence-supported clinical pathway for dry skin prevention and treatment. OBJECTIVE: The development of the pathway involved the following: a literature review was conducted and demonstrated that literature on dry skin is scarce. To compensate for the gap in the available literature, a modified Delphi method was used to collect information on prevention and treatment practice through a panel, which included 10 selected dermatologists who currently provide medical care for dermatology patients in Ontario. An advisor experienced in this therapeutic area guided the process, including a central meeting. Panel members completed a questionnaire regarding their individual practice in caring for these patients and responded to questions on assessment of dry skin etiology, frequency of skin care visits for consultation and follow-up, assessment, and referral to other specialties. The panel members reviewed a summary of all responses and reached a consensus. The result was presented as a clinical pathway. CONCLUSION: The panel concluded that our current awareness of dry skin and therefore prevention and effective treatment is limited; that identifying dry skin and its clinical issues requires tools such as clinical pathways, which may improve patient outcomes; and that additional research on dry skin etiology, prevention, and treatment is necessary.

The usefulness of the bilobed flap for lateral cheek defects.

The cheek and nose are common areas for skin cancers. There are multiple approaches to surgical excision and reconstruction, depending on the size of defect, tissue quality, adjacent cosmetic units and hairline. An effective solution to skin defects of the lateral cheek is the bilobed flap. This flap tends to be underused in the lateral cheek area because primary closure and skin grafts are perceived to be easier methods of reconstruction. However, the use of the bilobed flap for lateral cheek and other defect closures is encouraged. There are several basic principles that are key when performing this flap. These components of the procedure are highlighted.

La joue et le nez sont des zones courantes de cancer de la peau. Il existe de multiples modes d'excision et de reconstruction chirurgicales, selon la dimension de l'anomalie, la qualité des unités esthétiques adjacentes et la ligne des cheveux. Le lambeau bilobé constitue une solution efficace aux anomalies cutanées de la joue latérale. Ce lambeau tend à être sous-utilisé dans cette zone, parce que la fermeture primaire et les greffes cutanées sont perçues comme des modes de reconstruction plus simples. Cependant, les auteurs encouragent l'utilisation du lambeau bilobé pour refermer les anomalies de la joue latérale et d'autres anomalies. Il faut respecter plusieurs principes de base lorsqu'on utilise ce lambeau. Les éléments de l'intervention sont soulignés.

A newly modified 595-nm pulsed dye laser with compression handpiece for the treatment of photodamaged skin.

BACKGROUND AND OBJECTIVES: The pulsed dye laser set the standard of care for the treatment of vascular lesions, and recent modifications have enabled improved efficacy with fewer side effects. An investigational high energy, variable pulse duration pulsed dye laser has been modified to treat both vascular and pigmented lesions associated with photoaging. Each laser pulse is comprised of a sequence of eight uniform micropulses, which evenly distribute the pulse energy, effectively increasing the purpura threshold at any given fluence. Pigmented lesions are treated with a compression handpiece (CHP) that removes competing vascular target from the field, and helps to prevent purpura. This pilot study was undertaken to determine the optimum laser settings, and to investigate the ability of this device to improve vascular and pigmented lesions associated with photoaging. STUDY DESIGN/MATERIALS AND METHODS: Twenty-four patients with photoaged skin and phototype I-III were enrolled in the study. Thirteen received treatment for vascular and pigmented lesions, and 11 subjects were treated for pigmented lesions alone. Subjects received one to three treatments at 3-4 weeks intervals, and underwent 3- and 12-week follow-up evaluation. The degree of improvement was assessed by subject evaluation as well as comparison of standardized digital photographs by three independent dermatologists. Background erythema was treated with a 12-mm spot size, at a fluence of 7 J/cm(2), and a pulse width of 10 ms. The cryogen cooling was set at 30 mseconds with a 30 ms delay. Individual telangiectasias were treated with a 5- or 7-mm spot size at fluences of 9-14 J/cm(2) and pulse widths of 6-20 mseconds. Pigmented lesions were treated using a 5- or 7-mm spot size, with energy of 9-15 J/cm(2) and a pulse width of 1.5-10 ms without cooling. The CHP had a 7-mm spot size, and fluences of 9-16 J/cm(2), and pulse widths of 1.5 or 3 ms were used in the treatment of pigmented lesions. RESULTS: The treatment was well tolerated without the use of topical anesthetic. All subjects noted improvement in the both vascular and pigmented lesions, and were satisfied with their outcomes. Objectively, there was moderate improvement in background erythema, telangiectasia, and pigmented lesions. Three subjects who were treated with sun tans developed transient hypopigmentation and two subjects developed a transient textural change following pulse stacking for the treatment of pigmented lesions with the conventional handpiece. Purpura was noted in all patients treated for pigment with the conventional handpiece at pulsewidths less than 6 mseconds, as compared to only one that was treated with the CHP. Three patients treated in rapid succession for vascular, and then pigmented lesions with the CHP exhibited purpura, which was prevented in future treatments with 1-2 minutes of topical ice cooling between passes. CONCLUSIONS: This novel 595-nm pulsed dye laser, with a modified pulse sequence and CHP, now has the versatility to safely treat both pigment and vascular changes associated with photoaging.

Primary systemic amyloidosis presenting as extensive cutaneous ulceration.

BACKGROUND: We report a case of primary systemic amyloidosis in a 78-year-old Caucasian woman presented as a nonhealing ulcer on the right thigh for 3 months. Histopathology of the skin revealed widely thickened walls of middermal and subcutaneous vessels from deposition of amorphous eosinophilic material that stained positively with Congo red and crystal violet. OBJECTIVE: This case represents a very unusual presentation of primary systemic amyloidosis, one in which the cutaneous manifestations provided the first signs of a devastatingly widespread multiorgan infiltration of amyloid protein. CONCLUSION: This presentation of the disease may signify an advanced stage with a grave prognosis as our patient passed away 3 months after development of the cutaneous ulceration.

A common tumor, an uncommon location: basal cell carcinoma of the nipple and areola in a 49-year-old woman.

BACKGROUND: Basal cell carcinoma (BCC) occurring on sun-protected regions is an uncommon phenomenon. BCC of the nipple is an exceedingly rare event. METHOD: We review the literature on BCC of the female nipple and herein describe the eighth reported case in the English literature. Our patient was treated with Mohs micrographic surgery and sentinel lymph node biopsy. CONCLUSION: BCC of the nipple are extremely rare tumors with unclear etiology. They can be aggressive and are capable of causing significant morbidity and mortality if they are neglected or improperly treated. With continued reporting of the diagnosis, treatment, and follow-up of these patients, we may gain an understanding of the pathogenesis, as well as the best method of control for these unusual tumors.

Classic Kaposi's sarcoma in the Inuit of northern Quebec.

BACKGROUND: Classic Kaposi's sarcoma (KS) is predominantly a disease of eastern Mediterranean and Ashkenazi Jewish elderly men. Nevertheless, the disease has been reported to occur in people from various other ethnic and regional backgrounds. OBJECTIVE: We report, for the first time, the occurrence of classic KS in five Inuit people living in northern Quebec, Canada. METHODS AND RESULTS: We describe the case of a 69-year-old Inuit man with classic KS, and report four other cases of KS in the Inuit population, identified by a review of our hospital's dermatopathology records. CONCLUSION: The discovery of classic KS in the Inuit population of northern Quebec brings with it new questions as to the origins of the KS-associated herpes virus in this population. It is our belief that the answers to these questions are in the genotype of the virus that is present in this community.

Dermatologic surgery practice and skin cancer treatment in Canada: results of a national survey.

BACKGROUND: Although traditionally considered a medical subspecialty, dermatology has rapidly evolved over the past two decades to encompass a wide variety of cutaneous surgical procedures. OBJECTIVE: The study was carried out to evaluate the status of dermatologic surgery practice and skin cancer treatment in Canada. METHODS: In 2003, 550 practicing Canadian dermatologists were surveyed. RESULTS: Two hundred fifty-one dermatologists responded to the questionnaire, with the majority practicing in an urban part-time academic, part-time private setting. Statistics are presented on the types and demographics of dermatosurgical and cosmetic procedures performed, as well as on the specific dermatosurgical therapies used in the treatment of various cutaneous malignancies. CONCLUSIONS: The survey provides a current picture of dermatologic surgery practice and skin cancer treatment in Canada. The data suggest that Canadian dermatologists are further embracing surgical and cosmetic procedures.