Treating Glabellar Lines With Botulinum Toxin: Does Your Patient Need to Frown Steadily?

BACKGROUND: The variable relationship between the orbicularis supercilii and frontalis muscles may cause side effects with botulin toxin; steadily frowning is the usual recommendation. Eliminating the need to frown until all injections are over might enhance efficacy and lessen the neurotoxicity risks related to muscle exhaustion. OBJECTIVES: The goal of this study was to investigate whether the digital caliper-assessed distances between the medial and lateral corrugator injection sites and the midline differed significantly in patients persistently frowning from patients resting. METHODS: Seventy-six individuals with glabellar wrinkles treated with botulinum toxin in the authors' private practices for glabellar lines voluntarily contributed their retrospective data about the positions of injection sites. The investigators had freely chosen to inject the medial and lateral sections of the corrugator supercilii during persistent maximum frown or at rest. RESULTS: The mean differences in distances between the medial and lateral injection points and the estimated midline were clinically trivial (1.0 ± 1.28 and 1.5 ± 2.53 mm, respectively), although the distances between the relaxed and contracted medial and lateral injection sites exceeded 1.8 and 2.5 mm in 33.9% and 46.4% of patients, respectively. Distance differences, not significant before 40 years old, were statistically significant only for the lateral injections in older patients (on average, 1.9 ± 3.01 mm). CONCLUSIONS: The average distances from the medial and lateral injection points and the midline appear minimally different in patients who frown until all injections are over and, conversely, patients who rest. Persistently frowning might be advisable only in patients older than 40. Facial asymmetries may be a confounding factor.

Clinical efficacy and safety of polynucleotides highly purified technology (PN-HPT®) and cross-linked hyaluronic acid for moderate to severe nasolabial folds: A prospective, randomized, exploratory study.

INTRODUCTION: The mandibular profile undergoes progressive wasting with aging, and the deepening of nasolabial folds (NLFs) has a leading role. Hyaluronic acid (HA) efficiently controls tissue hydration and permeability to small and large molecules. NLFs are an acknowledged HA target; at the same time, another class of agents, PN-HPT® (Polynucleotides Highly Purified Technology), enjoy growing acknowledgement in aesthetic medicine. This exploratory, prospective study probed the rationale of sequentially associating PN-HPT® as a first priming agent acting in the skin followed by HA dermal filler injections for correcting moderate to severe NLFs. METHODS: Following strict inclusion and exclusion criteria, the authors screened Caucasian ambulatory women aged 40-65 with moderate to severe NLFs and randomly selected two NLFs for each enrolled woman. Due to the purely explorative nature of the study, the authors initially planned to enroll no >10 women. According to a split-face design, the selected right-side NLFs received 4 ml of PN-HPT® intradermally in the initial priming phase ("NLF Rx group"); the selected left-side NLFs received 4 ml of saline (placebo) ("NLF Lx group"). After 3 and 6 weeks, all patients received 2 ml of subdermal cross-linked HA over both NLF areas (4 ml overall). The total study follow-up was 6 months after the first injection, with objective assessments, based on the qualitative and quantitative Antera 3D® and Vectra H2® skin imaging technologies, after 6 weeks and 3 and 6 months. RESULTS: Because of the favorable early outcomes, the authors let enrollment progress between January and June 2020 up to a total of 20 women and 40 NLFs. All treated women completed the six-month follow-up without reporting side effects, even clinically minor. The Antera 3D® device demonstrated that wrinkles and skin texture significantly improved in the NLF Rx after 6 weeks (monotherapy phase) and 3 and 6 months (PN-HPT® priming + HA phase) compared with baseline. HA levels, measured with the quantitative Vectra H2® assessment technology in the right NLFs, were significantly higher than contralaterally at both 3 and 6 months. CONCLUSIONS: Although conceived only as an exploratory investigation, the study confirmed that PN-HPT® monotherapy might be a valuable and effective option to rapidly improve the skin dermis texture and quality in individuals with moderate to severe NLFs. Acting as a priming agent in the skin, PN-HPT® prolong the clinical efficacy of cross-linked HA. Well-designed trials in larger treatment groups will hopefully confirm these early promising results.

Hyaluronic Acid Fillers, Needle Contamination by Fastidious Microorganisms, and Risk of Complications.

BACKGROUND: Complications are becoming ever more common with the increased use of hyaluronic acid (HA) fillers in aesthetic medicine. Complications due to needle contamination with fastidious microorganisms are no exception. OBJECTIVE: To perform, in a top Italian aesthetic medicine facility, what the authors think is the first monitoring program of microbial needle contamination of cross-linked HA gel fillers after the prefilled syringes with gel residues were stored for retouches after the first aesthetic procedure. METHODS: Needle contamination monitoring study, performed between January and November 2019, on 35 needles (caliber, 30 and 27 G) stored at 4°C in their resealed filler packages for possible retouch after a first aesthetic treatment involving the middle and lower facial thirds. Women's age: 35 to 70 years old. RESULTS: The search for contaminating agents of the 3 monitored bacterial contaminants ( Staphylococcus aureus , Streptococcus pyogenes , and anaerobes) as well as yeasts and molds always tested negative. In the days and months after treatment, no patients in post-treatment controls showed evidence of infection in the treated areas. CONCLUSION: The observational retrospective study confirms that good storage conditions, including monitored refrigeration, avoid the risk of contamination of partially used HA gel fillers by fastidious microorganisms.

Heterogeneous crow's feet line patterns and customized botulinum toxin rejuvenating treatment.

BACKGROUND: From early dynamic lines in smiling and squinting young people, crow's feet lines in the lateral canthal region evolve through prolonged tissue remodeling into mature, stable rhytids after the mid-to-late thirties, and requests for rejuvenating treatment. Because of the heterogeneous fanning behavior of crow's feet lines, individualizing neuromodulation with botulinum toxin injections might be a sound strategy to maximize aesthetic outcomes. AIMS: To investigate the prevalence of variable crow's feet line patterns at maximum contracture and while smiling and comment on the relative distribution of such patterns and the influence of aging. These considerations will be the basis and rationale for future studies that will individualize the total 24-unit dose according to the distribution of crow's feet lines. METHODS: Identifying CFL orientation at maximum frown and while smiling; assessment tool: the four-class 2015-version of Kane's classification further modified by converting the former "central fan pattern" into a new, more precisely defined "extended full-fan pattern" class. RESULTS: The 323 cohort subjects had a mean age of 51.5 ± 9.28 years. Although with some differences, outcomes in a central-southern real-world European Caucasian population appear similar to the distribution first studied in 2003 in a highly selected population in New England involved in double-blind clinical trials. The full-fan pattern predominated both at maximum contraction and when smiling, followed in prevalence by the upper-fan pattern at maximum contraction and the extended full-fan pattern while smiling. Age significantly influenced the crow's feet line pattern-lower-fan patterns were more frequent than other patterns in the real-world younger middle-age group (40-49 years old); full-fan and extended full-fan patterns progressively more prevalent with aging. CONCLUSIONS: The study confirms but somewhat modifies the previous evidence about the non-homogeneous distribution of crow's feet line fanning patterns in different age groups and reinforces the case to individualize the topography of botulinum toxin injections.

Clinical commentary about foreign body complications over 20 years after polymethyl-methacrylate face implants and control of late sequelae with Polynucleotides Highly Purified Technology (PN-HPT® ).

INTRODUCTION: Mainly in the past, foreign body complications, including granuloma, were pretty frequent after semi-permanent polymethyl-methacrylate (PMMA) implants. RESULTS: The authors describe a twenty-year history of recurring post-PMMA complications interspersed by long uneventful years, with acute edematous side effects evolving into unpleasant skin dystrophia with persistent cutis laxa. The case report also discusses a simple clinical algorithm to discriminate among foreign body complications with particular attention to granulomas. CONCLUSIONS: The authors conclude by discussing the benefits of the anti-dystrophic treatment with natural-origin remodeling PN-HPT® (Polynucleotides Highly Purified Technology).

PN-HPT® (Polynucleotides Highly Purified Technology) in facial middle third rejuvenation. Exploring the potential.

BACKGROUND: Wasting of soft tissues leads to flattening and deflation of the aging midface skin. Polynucleotides Highly Purified Technology (PN-HPT® ) demonstrated dermal hydration and elasticity as well as fibroblasts vitality and activity. AIMS: To probe the value of PN-HPT® in middle third rejuvenation in an open-design, exploratory prospective cohort study in 40 real-life ambulatorily treated women. METHODS: Three treatment sessions-at baseline (2-ml prefilled syringe containing 10 mg/ml PN-HPT® , 10 mg/ml hyaluronic acid, 200 mM mannitol) as intradermic gel, and after 3 weeks (2-ml prefilled syringe containing 20 mg/ml PN-HPT® intradermic gel) and 6 weeks (same treatment as baseline). The protocol allowed supplemental treatment with specifically formulated PN-HPT® (7.5 mg/ml) when needed in periocular and eyelid areas. ASSESSMENTS: sequential photographs of the facial middle third at baseline, third treatment session and 6-8 weeks after the third treatment session; scoring of overall skin quality and texture, skin quality determinants (wrinkles and skin roughness, skin elasticity, skin brightness), scar appearance, and subjective satisfaction with impromptu 10-cm Visual Analogue Scales. RESULTS: Significant improvement of overall skin quality and texture (from 7.0 ± 1.06 at baseline session to 7.8 ± 0.99 at follow-up), associated with highly significant improvements of wrinkles and skin roughness, elasticity, and brightness (-17.1%, +39.6%, and +51.1%, respectively). The severity scores of post-acne scars decreased from 7.6 ± 1.32 to 4.2 ± 2.13. Individual satisfaction score at the end of treatment: 0.8 ± 0.28. CONCLUSIONS: PN-HPT® candidate as a valuable option for facial middle third rejuvenation. Further trials will hopefully confirm these early results.

Dynamic quadripolar radiofrequency treatment of vaginal laxity/menopausal vulvo-vaginal atrophy: 12-month efficacy and safety.

BACKGROUND: Twelve-month extension of a previous spontaneous exploratory study investigating safety and efficacy of a new low-energy dynamic quadripolar radiofrequency (DQRF) device in: A) premenopausal women with symptoms of vaginal laxity, with special reference to dysuria, urinary incontinence and unsatisfactory sexual life (vaginal laxity arm of the study); B) postmenopausal women with vulvovaginal atrophy/genitourinary syndrome of menopause (VVA/GSM) and VVA/GSM-related symptoms (VVA/GSM arm of the study). DQRF treatment schedule in both study arms: 4 to 6 procedures of 15 to 20 min every 14 days (vaginal laxity, range 12-17 days; VVA/GSM, range 13-16). Operative temperatures in vaginal target tissues during procedure: vaginal laxity, 42 °C (range 40-43 °C); VVA/GSM, 40 °C (range 40-42 °C). METHODS: In the vaginal laxity arm of the study, 25 women with subjective sensation of vaginal introital laxity (very to slightly loose). Assessment of urinary incontinence, satisfaction with sexual relationship and contribution of pelvic organ prolapse: Vaginal Laxity Questionnaire (VLQ, Italian certified translation) and short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12, Italian certified translation). Further evaluation of sexual gratification: Sexual Satisfaction Questionnaire (SSQ). In the VVA/GSM arm of the study, 32 women with objective evidence of VVA and vaginal dryness and/or dyspareunia as most bothersome symptoms. Assessment of VVA/GSM symptoms and overall satisfaction with sexual life: specifically designed 10-cm visual analogue scales. RESULTS: All 4 to 6 planned DQRF sessions were well tolerated in both the vaginal laxity and VVA/GSM arms of the study, with no troubling pain, thermal injury or other immediate adverse effects during all the procedures. All screened women completed the planned DQRF treatment sessions in both arms of the extension study. There was no participant attrition with only a few occasionally missing visits over the 12-month follow-up period. Improvements were rapid in self-perception of introital looseness and related symptoms like dysuria/urinary incontinence and unrewarding sexual relationship (vaginal laxity patients) and atrophy-related symptoms including painful and unsatisfactory sexual activity (VVA/GSM patients). Participating women consistently reported wide-spectrum strong clinical improvements by the end of the planned DQRF sessions. Clinical improvements remained steady for the whole follow-up period in postmenopausal women; a statistically non-significant tendency to slight deterioration in VLQ, PISQ-12 and SSQ mean scores was detected after 6 to 9 months of follow-up in the vaginal laxity arm of the study. CONCLUSIONS: Safety was excellent during all DQRF procedures and over the 12 months following the end of the treatment sessions. VLQ, PISQ-12 and SSQ scores (women with vaginal laxity), VAS self-evaluation of VVA/GSM symptoms and overall satisfaction with sexual life (women with VVA/GSM symptoms) improved rapidly, reaching almost normal levels by the last DQRF session and suggesting rapid, but also persistent, vaginal rejuvenation in both indications. A late tendency to some slight deterioration in women treated for vaginal laxity suggests such women might benefit from new DQRF treatments 6 to 9 months after the previous cycle.

Photoepilation and Skin Photorejuvenation: An Update.

The effectiveness of intense pulsed light (IPL) and laser devices is widely accepted in aesthetic dermatology for unwanted hair removal and treatment of a variety of cutaneous conditions. Overall, most comparative trials have demonstrated similar effectiveness for IPL and laser devices. Literature studies alternatively favor the IPL and laser concepts, but the incidence of severe local pain and side effects were generally lower with IPL. IPL phototherapy, already established as a sound option in photoepilation and treatment of photoaging, hyperpigmentation and other skin conditions, is also considered first choice in the phototherapy of skin vascular malformations. When treating large areas, as often required in photoepilation and many aesthetic dermatology indications, IPL technologies show advantages over laser-based devices because of their high skin coverage rate. Compared to lasers, the wide range of selectable treatment settings, though a strong advantage of IPL, may also imply some more risk of local thermal side effects, but almost only in the hands of poorly trained operators. Overall, the strongest advantages of the IPL technologies are robust technology, versatility, lower purchase price, and the negligible risk of serious adverse effects in the hands of skilled and experienced operators.

A Study Case in Photoepilation, the HPPL™ and IFL™ Technologies.

The High Power Pulsed Light™ [HPPL™] and Incoherent Fast Light™ technologies [IFL™, Novavision Group S.p.A., 20826 Misinto (MB), Italy] are recent innovations in the field of unwanted hair removal with intense pulsed light devices. IFL™ is a further improvement over the already advanced characteristics of the HPPL™ technology. A selection of photoepilation case histories with the HPPL™ and IFL™ technologies is presented; a short introduction highlights the main features of the two technologies. All study materials were appropriately peer-reviewed for ethical problems.

Case Histories of Intense Pulsed Light Phototherapy in Dermatology - the HPPL™ and IFL™ Technologies.

The intense pulsed light (IPL) and laser technologies are widely used for skin rejuvenation and for treating several dermatological disorders such as skin dyschromia and acne, and for non-ablative dermal remodeling of rhytides and hypertrophic scars. Technological evolution is rapid. The High Power Pulsed Light™ [HPPL™] and Incoherent Fast Light™ technologies [IFL™, Novavision Group S.p.A., 20826 Misinto (MB), Italy] are recent innovations in the field of IPL technologies; IFL™ is a further evolution of the already advanced HPPL™ system. The paper presents a selection of case histories of dermatological lesions treated with the HPPL™ and IFL™ technologies. All study materials were appropriately peer-reviewed for ethical problems.

Technological evolution in the radiofrequency treatment of vaginal laxity and menopausal vulvo-vaginal atrophy and other genitourinary symptoms: first experiences with a novel dynamic quadripolar device.

BACKGROUND: This paper was a spontaneous, non-sponsored exploratory study to investigate the safety and efficacy of two schedules of thermal treatment with a new low-energy dynamic quadripolar radiofrequency (DQRF) device in: A) premenopausal women referring perception of vaginal introital laxity and related symptoms, with special reference to dysuria and urinary incontinence and unsatisfactory sexual activity (vaginal laxity arm of the study); B) postmenopausal women with vaginal atrophy and dryness and other vulvo-vaginal atrophy and genitourinary syndrome of menopause (VVA/GSM) related symptoms (VVA/GSM arm of the study). METHODS: As for the vaginal laxity arm of the study, 12 women with perception of very to slightly loose vaginal introital laxity underwent five 20-min DQRF thermal treatment sessions every 14±1 days. A Vaginal Laxity Questionnaire (VLQ, certified Italian translation) and short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12, Italian certified translation) were used to assess urinary incontinence, sexual gratification and the contribution of any concomitant pelvic organ prolapse. As for the VVA/GSM arm of the study, 13 women with objective evidence of VVA and vaginal dryness and/or dyspareunia rated as moderate/severe most bothersome symptoms underwent four 10-min DQRF sessions every 10±1 days. Specifically designed visual analogue scales (VAS) for VVA/GSM symptoms and overall satisfaction with sexual life were used. RESULTS: No adverse effects, including thermal burns or injuries, were reported during or after treatments in either arm of the study. Eleven of the enrolled women completed the five planned DQRF treatment sessions in the vaginal laxity arm of the study; 12 women completed the four DQRF sessions planned in the VVA/GSM arm of the study. Clinically and statistically significant improvements in self-perceived sensation of looseness and symptoms like dysuria/urinary incontinence and sexual function in the vaginal laxity arm of the study as well as VVA/GSM symptoms and overall satisfaction with sexual life in the VVA/GSM arm of the study. Improvements were already reported at the first assessment visit before the end of the planned DQRF sessions of each arm of the study, after, respectively, 56±4 and 30±3 days. CONCLUSIONS: The DQRF treatment was well tolerated, with no pain during the procedure and no untoward effect reported over the 2-month follow-up periods in both the vaginal laxity and VVA/GSM arms of the study. Improvements in self-reported VLQ and PISQ-12 scores (vaginal laxity arm) and VAS self-evaluation of VVA/GSM symptoms and overall satisfaction with sexual life (VVA/GSM arm of the study) were rapid and persistent. This suggests rapid and persistent vaginal rejuvenation as the basis of subjective improvement in symptoms and decreased sexual distress in both indications, including dysuria and urinary incontinence in menopausal women. Such promising exploratory findings deserve confirmation in larger studies.