Validation of a Midfacial Scale and Its Use in a Randomized, Evaluator-Blinded Study of CPM-HA-V.

BACKGROUND: Age-related loss of midfacial contour is frequently corrected using dermal fillers. A validated photonumeric scale is beneficial when evaluating post-treatment aesthetic improvement. OBJECTIVE: To present scale-development activities for the Merz Cheek Fullness Assessment Scale (MCFAS) and report pilot-study results of a hyaluronic-acid filler (Belotero Volume with Lidocaine; CPM-HA-V) to treat midfacial volume loss. METHODS: A 5-point photonumeric scale was developed to objectively assess midface volume loss. Rater reliability was evaluated using live assessments. The clinical relevance of a 1-point difference in severity grade was evaluated using photographic comparisons. Pilot-study participants, with moderate-to-severe volume loss on the MCFAS, were randomized 2:1 to treatment or untreated control. Effectiveness was evaluated using the MCFAS, and adverse events were recorded. RESULTS: The MCFAS demonstrated substantial intra- and interrater agreement among physicians (weighted kappa > 0.6). The mean absolute difference (95% confidence interval) in scale ratings was 1.12 (1.00, 1.24) for photographic pairs differing by one grade and was 0.55 (0.48, 0.63) for pairs of the same grade, suggesting a 1-point difference is clinically relevant. In the pilot study, significant  (P < 0.0001) differences were observed in MCFAS response rates between treatment and control. No safety concerns were identified. CONCLUSION: The MCFAS is a validated, reliable, and clinically relevant photonumeric scale for rating midfacial volume loss in males and females of various ages and skin types. In a pilot study, CPM-HA-V was found to be safe and tolerable, and the MCFAS was able to detect clinically meaningful post-treatment changes. J Drugs Dermatol. 2024;23(1):     doi:10.36849/JDD.7981.

Efficacy and Safety of RelabotulinumtoxinA, a New Ready-to-Use Liquid Formulation Botulinum Toxin: Results From the READY-1 Double-Blind, Randomized, Placebo-Controlled Phase 3 Trial in Glabellar Lines.

BACKGROUND: RelabotulinumtoxinA (RelaBoNT-A, Galderma, Uppsala, Sweden) is an innovative, ready-to-use liquid botulinum toxin A, produced using PEARLTM manufacturing technology that yields a potent, complex-free formulation. OBJECTIVES: The READY-1 study examined efficacy and safety outcomes following a single RelaBoNT-A treatment for glabellar line correction. METHODS: Adults with moderate-to-severe glabellar lines received RelaBoNT-A (50 U) or placebo in a 3:1 randomized, 6-month, Phase 3, multicenter, double-blind study. Primary endpoints (examined at Month 1, maximum frown) comprised the composite ≥2-grade response, defined as ≥2-grades' improvement from baseline on concurrent investigator (GL-ILA) and subject (GL-SLA) severity scales (US endpoint), and the investigator-reported responder rate for subjects scored as 0 (none) or 1 (mild) (GL-ILA scale only; EU endpoint). Subject satisfaction and treatment-emergent adverse events (TEAEs) were reported. RESULTS: Overall, 297 adults were randomized and treated. Month 1 composite ≥2-grade responder rate was 82.9% (RelaBoNT-A, N=199) versus 0% (placebo, N=67; p<0.001). Month 1 investigator-reported none-or-mild responder rate was 96.3% (RelaBoNT-A) versus 4.5% (placebo; p<0.001). GL-ILA scores (none-or-mild; ≥1-grade improvement) remained higher with RelaBoNT-A (23.6%; 58.1%) versus placebo (1.5%; 10.4%) through Month 6 (p<0.001). In the Kaplan-Meier analysis, 75% still showed GL-ILA and GL-SLA improvements from baseline at 169 days (end-of-study). Subjects reported onset of effect from Day 1 (39%) and satisfaction with natural-looking results (96.8%; Month 1). RelaBoNT-A-related TEAEs were low (3.6%) and typically mild. CONCLUSIONS: A single RelaBoNT-A treatment was effective and demonstrated a favorable safety profile. RelaBoNT-A provided significant improvements in glabellar line severity, high satisfaction, rapid onset, and enduring effectiveness throughout the 6-month study period.

ODSS vs. ABSIS and PDAI oral parts in pemphigus vulgaris: inter-rater reliability and testing times.

OBJECTIVES: The existence of standard methods for diagnosis and measuring the severity of diseases leads to a more accurate severity assessment, the possibility of following up, and the possibility of comparing the results of studies. This study aimed to compare different pemphigus vulgaris (PV) assessment methods regarding inter-observer reliability and testing times-focusing on oral parts. MATERIALS AND METHODS: Two dermatologists evaluated orally involved PV patients by oral parts of Autoimmune Bullous Skin Disorder Intensity Score (ABSIS), Pemphigus Disease Area Index (PDAI), and Oral Disease Severity Score (ODSS). RESULTS: Seventy patients completed the study. The intraclass correlation coefficient showed the evaluators' agreements on ABSIS, PDAI, and ODSS with 0.98, 0.94, and 0.95, respectively. Reliability analyses showed near-perfect relationships between each scoring methods pairs. There was no association between lesion sites and disease severity. The PDAI scoring duration was significantly shorter, and the ABSIS scoring duration was significantly longer. CONCLUSION: ODSS is valid for evaluating oral involvement in patients with PV and relates to ABSIS and PDAI almost perfectly. Besides, it was shown that the evaluation of patients' oral involvement based on PDAI and ODSS is done in about 1 min, which seems clinically reasonable.

A Novel 3-Point Injection Technique for OnabotulinumtoxinA in the Upper Depressor Anguli Oris.

BACKGROUND AND OBJECTIVE: To evaluate the efficacy and safety of onabotulinumtoxinA (ONA) injections to the depressor anguli oris (DAO) to improve downturned mouth. PATIENTS AND METHODS/MATERIALS: This prospective, placebo-controlled, study enrolled subjects aged 18 to 65 years. Injections were performed using a novel 3-point technique in the upper DAO (1.5 U/injection site). The primary end point was a DAO contraction scale 1-grade improvement. Subjective evaluation was performed using the Global Aesthetic Improvement Scale (GAIS). RESULTS: Ten subjects received ONA and 10 placebo (saline) injections. In ONA-treated subjects, DAO scores showed significant improvements at Weeks 4 and 12 ( p < .001) compared with baseline. No significant difference between visits was observed for placebo-injected subjects. Global Aesthetic Improvement Scale scores showed that 100% of subjects were improved compared with baseline at Week 4% and 90% at Week 12. By contrast, 90% and 80% of placebo-treated subjects had "no change" in their DAO appearance at Weeks 4 and 12. Subject GAIS assessments matched the live evaluator at Week 4; 60% continued to report improvement at Week 12. Treatment was well tolerated. CONCLUSION: OnabotulinumtoxinA injections to the DAO using a 3-point technique provide clinically meaningful improvements in appearance. Treatment was well tolerated and in most individuals lasted at least 12 weeks. IDENTIFIER: ClinicalTrials.gov NCT04240535.

Cellulite Pathophysiology and Psychosocial Implications.

BACKGROUND: Cellulite is a highly prevalent aesthetic condition in postpubertal women. OBJECTIVE: The objective of this article was to describe the latest data on the pathophysiology of cellulite and to highlight the psychosocial aspects that should be considered when treating cellulite. METHODS: A roundtable meeting was convened to discuss and share views on the latest data on the pathophysiology and psychosocial aspects of cellulite. The participants' experience helped guide a narrative review on this topic. RESULTS: The pathophysiology of cellulite primarily involves fibrous septal changes. Strategies targeting the fibrous septa have shown the most consistent efficacy, while showing inconsistent or short-term results when targeting the other components of cellulite, such as decreased dermal thickness, vascular alterations, and inflammation. Female sex, increased age, and high body mass index contribute to cellulite pathophysiology. CONCLUSION: Patients seeking treatment for cellulite are willing to endure numerous treatments, high cost, temporary and/or delayed results, and invasive procedures with potential adverse effects. Psychological discomfort has been reported among patients with cellulite, and understanding their behaviors and psychological characteristics can help clinicians provide better care to these patients seeking treatment.

Cellulite: Clinical Challenges and Future Perspectives.

BACKGROUND: Existing cellulite interventions pose various clinical challenges related mostly to ecchymosis and recovery time. OBJECTIVE: To discuss the current treatment options for minimizing recovery time, efficacy of these options, and investigations into possible future approaches. METHODS: A roundtable meeting was convened to discuss and share views on the clinical challenges seen in the present practice of cellulite treatments along with future approaches and mitigation strategies. The participants' views helped guide a narrative review on this topic. RESULTS: Cosmetic clinicians have a range of new interventions to choose from for cellulite improvement, each with different benefits and safety aspects. Bruising is a typical side effect that is seen with treatments targeting the fibrous septa, such as subcision and injectable treatments, and in some cases may produce long-lasting hyperpigmentation from postinflammatory hyperpigmentation or hemosiderin staining. Various strategies that could potentially mitigate bruising and other adverse effects of cellulite treatment are under clinical investigation, including, but not limited to, different injection techniques and dilutions, compression garments, cold packs, arnica gel, pulsed dye laser treatment, intralesional epinephrine, and tranexamic acid. CONCLUSION: Clinical challenges including varying treatment outcomes and certain treatment sequelae remain, and further research is needed to prevent side effects and improve treatment outcomes.

Development and Validation of a Photonumeric Scale for Evaluation of Jawline Contour.

BACKGROUND: A naturally aged face is often characterized by a noticeable lack of jawline contour and decreased volume in the lower region. Several options are available to redefine the jawline. To objectively evaluate treatment-related improvements in clinical practice and research, a validated photonumeric scale is needed. OBJECTIVE: To present scale-development methods for the Merz Jawline Assessment Scale and establish its reliability. METHODS: A 5-point photonumeric scale was developed to objectively assess jawline volume loss and contour disruption using male and female subjects of various ages and skin types. Seven board-certified dermatologists and plastic surgeons evaluated 90 subjects live in 2 sessions, 3 weeks apart to establish intra- and interrater reliability. RESULTS: The weighted kappa for intra- and interrater agreement were ≥ 0.7 in all cases. Intrarater agreement between the 2 rating sessions was nearly perfect (median weighted kappa = 0.908). Substantial interrater agreement between each rater pair was also demonstrated for both rating sessions. CONCLUSION: The Merz Jawline Assessment Scale is a validated and reliable photonumeric scale for rating loss of jawline volume and contour. The scale maintains its validity and reliability with reproducible results across a diverse group of males and females of various ages and Fitzpatrick skin types. J Drugs Dermatol. 2023;22(2):203-209. doi:10.36849/JDD.7193.

Aesthetic Implantation of Calcium Hydroxylapatite Does Not Interfere With Radiological Assessment of Bones in the Dorsum of the Hands.

BACKGROUND: Calcium hydroxylapatite (CaHA) is a radiopaque dermal filler used to provide volume correction in the dorsum of the hand. OBJECTIVES: The aim of this study was to evaluate whether CaHA implantation in the dorsum of the hand interferes with radiological assessment by obscuring the bones. METHODS: This 2-year, prospective, single-center, open-label study enrolled 20 subjects with Merz Hand Grading Scale (MHGS) grades ranging from moderate (MHGS 2 or 3; n = 10) to very severe (MHGS 4; n = 10). All subjects received an initial CaHA treatment and were offered up to 3 retreatments to provide volume correction in the dorsum of the hands, over a period of 18 months. Bone obscuration was assessed by blinded, licensed radiologists responsible for interpreting plain radiographs (X-rays). RESULTS: CaHA was seen to be present in 100% of hands in Month 1 X-rays and in 83.3% in Month 24 X-rays, but no bone obscuration was reported in any X-rays at any evaluated time point. CONCLUSIONS: According to blinded radiologists, treatment with CaHA in the dorsum of the hand does not obscure radiographic assessment of the bones seen on X-rays up to 24 months after initial injection. The safety of CaHA retreatment was also demonstrated by the lack of bone obscuration after multiple retreatments.

Compositional and Morphological Analysis of Salt Stress Tolerant Mannitol-1-phosphate Dehydrogenase (mtlD)-Transgenic Potato Plants.

Undesired effects often occur in genetically modified (GM) plants, especially during metabolite engineering. Nevertheless, conducting a comparative study between GM and non-GM plants can identify the unintended alterations and facilitate the risk assessment of GM crops. This research compared the morphology and composition of a transgenic potato plant expressing mannitol-1-phosphate dehydrogenase (mtlD), with its non-transgenic counterpart. The results indicated significant differences in plant height, number of leaves, length and width of leaves, as well as tuber number and weight between the transgenic and non-transgenic plants. However, compositional analysis revealed no significant differences in soluble protein, starch, total sugar, fructose, fiber, and ascorbate contents between mtlD-GM and non-GM potatoes. Nevertheless, sucrose and glucose levels were found to be higher in the transgenic potato tubers and leaves, respectively, when compared to the non-transgenic plants. In addition to ammonium, potassium, chloride, nitrite, and nitrate levels, significant differences were observed in the amino acids asparagine, aspartic acid, glutamic acid, isoleucine, leucine, lysine, serine, and valine between the GM and non-GM plants. Apart from the target gene product, mannitol, all the changes in chemical compositions observed in the transgenic potato plants fell within the ranges of normal variability for potato plants. Moreover, despite some phenotypical differences between the mtlD-GM potato and its non-GM counterpart, it is believed that this variation is a common phenomenon among potato varieties. In conclusion, the morphological and compositional analysis of the mtlD-GM potato plant revealed substantial equivalence with its non-transgenic counterpart.

Effectiveness and Safety of Calcium Hydroxylapatite With Lidocaine for Improving Jawline Contour.

BACKGROUND: One of the early signs of aging is loss of jawline contour. Not all cases require surgical intervention and soft-tissue augmentation with injectable fillers may restore the profile and youthful appearance of the jawline. OBJECTIVE: To demonstrate the effectiveness and safety of calcium hydroxylapatite with lidocaine [CaHA (+); Radiesse® (+)] to improve the contour of jawline after deep (subdermal and/or supraperiosteal) injection. METHODS: Healthy eligible patients with moderate or severe ratings on the Merz Jawline Assessment Scale (MJAS) were randomized 2:1 to treatment with CaHA (+) or to control. Patients in the control group remained untreated until week 12, then received delayed treatment. Touch-ups were allowed in both groups, and re-treatment was allowed in the treatment group only. Effectiveness was evaluated on the MJAS, patient and investigator Global Aesthetic Improvement Scales, and FACE-Q™ questionnaires. Adverse events were recorded over a 60-week period. RESULTS: Treatment response rate (≥1-point MJAS improvement) was 93/123 (75.6%) for the treatment group and 5/57 (8.8%) for the control/delayed-treatment group at week 12. The difference between response rates was statistically significant (P<0.0001), showing superiority of treatment over control. Satisfaction with aesthetic improvement was reported by patients and treating investigators throughout the study. A total of 76/113 (67.3%) patients who responded to treatment 12 weeks after initial injection also demonstrated persistent improvement 48 weeks after initial treatment. The study demonstrated a favorable safety profile, with no reported unexpected adverse events. CONCLUSIONS: CaHA (+) is a safe and effective treatment for improving the contour of the jawline. J Drugs Dermatol. 2021;20(11): 1231-1238. doi:10.36849/JDD.6442.

AbobotulinumtoxinA for the Treatment of Moderate-to-Severe Glabellar Lines: A Randomized, Dose-Escalating, Double-Blind Study.

OBJECTIVE: To evaluate the efficacy and safety of AbobotulinumtoxinA (ABO) dose escalation in the correction of moderate-to-severe glabellar lines. DESIGN: Phase 2, 36-week, multicenter, randomized, dose-ranging, double-blind, placebo-controlled study. METHODS: Adults with moderate-to-severe glabellar lines received a single ABO treatment, dosed at 50, 75, 100, or 125 U, or placebo. Primary endpoint was week 4 composite ≥2-grade responder rate among those achieving a severity score of 0 (none) or 1 (mild) at maximum frown, evaluated using concurrent investigator and subject assessments. Secondary endpoints included ≥1-grade severity improvement, duration of effect, and reporting of treatment-emergent adverse events (TEAEs). RESULTS: Overall, 399 subjects were included (88.2% were female). Week 4 composite ≥2-grade ABO responder rate was 80.0% (50 U), 88.8% (75 U), 90.0% (100 U) and 95.1% (125 U), versus 2.6% with placebo (P<0.001). Responder rate (≥1-grade) ranged between 53% (50 U) and 69% (125 U) at week 24 and between 18% (50 U) and 31% (125 U) at week 36. Median time (weeks) to return to baseline severity/worse, among those scoring 0 (none) or 1 (mild), was 32.3 (50 U), 34.3 (75 U), 36.0 (100 U) and 36.6 (125 U), versus 23.7 (placebo). ABO-related TEAEs were reported in 4% of subjects (80% were mild). No seroconversion to ABO neutralizing antibodies was seen. CONCLUSION: A single ABO treatment provided rapid and effective improvements in glabellar line severity at all doses. Higher doses tended to demonstrate elevated response rates and longer duration of effect. All ABO doses were well-tolerated with low TEAE incidence. J Drugs Dermatol. 2021;20(9):980-987. doi:10.36849/JDD.6263.

A Randomized, Comparator-Controlled Study of HARC for Cheek Augmentation and Correction of Midface Contour Deficiencies.

BACKGROUND: HARC is a soft and flexible hyaluronic acid filler containing lidocaine, manufactured using XpresHAn® technology, restoring natural-looking volume and soft contours. OBJECTIVES: To evaluate safety and effectiveness of HARC for cheek augmentation and correction of midface contour deficiencies compared to a control product HAJV (hereafter referred to as Control). Primary objective was to demonstrate non-inferiority of HARC compared to the Control, by blinded evaluation of change from baseline in midface fullness 12 weeks after last injection, using a 4 grade midface volume scale (MMVS). MATERIALS AND METHODS: Subjects over the age of 21 with loss of fullness in the midface area (MMVS score 2, 3, or 4) were randomized 2:1 to treatment with HARC(n=142) or Control (n=68). Optional touch-up was allowed after 4 weeks. Study assessments included MMVS, aesthetic improvement, subject satisfaction, and safety. Subjects were followed for 48 weeks. RESULTS: Overall, most subjects were female (89%) and mean age was 53 years (range 24-80). Total mean volume injected was 4.3 mL for HARC and 4.9 mL for Control. Primary objective was met; mean change from baseline in MMVS score at week 12: -1.4 (HARC), -1.3 (Control), 95% CI: -0.22, 0.06. HARC effectiveness was supported by a high degree of aesthetic improvement and subject satisfaction throughout 48 weeks. Related adverse events were generally mild and transient. CONCLUSIONS:  HARC was well tolerated and non-inferior to Control for correction of midface fullness at 12 weeks after last injection. Aesthetic improvement and subject satisfaction were high and lasted through week 48.  J Drugs Dermatol. 2021;20(9):949-956. doi:10.36849/JDD.6191.

Validation of Photonumeric Assessment Scales for Temple Volume Deficit, Infraorbital Hollows, and Chin Retrusion.

BACKGROUND: Assessment scales are valuable tools in aesthetic clinical research and practice. OBJECTIVE: To validate 3 photonumeric scales covering temple volume deficit, infraorbital hollows, and chin retrusion. MATERIALS AND METHODS: Subjects reflecting the whole range of the scales were assessed independently by 3 evaluators at 2 separate occasions. Intraobserver agreement (the ability of each evaluator to assess the same grade for a specific subject at both evaluation occasions) and interobserver agreement (the degree to which evaluators independently provided identical grades for the same subject) were measured by weighted kappa statistics and percent exact agreement. RESULTS: Approximately 70 subjects were included in each scale validation. The predefined success criteria of an intraobserver weighted kappa coefficient of ≥0.6 and an interobserver median pairwise weighted kappa coefficient of ≥0.6 were met for each scale. These results indicate substantial agreement, both between the 2 evaluations, and between the 3 evaluators. CONCLUSION: These scales covering temple volume deficit, infraorbital hollows, and chin retrusion are validated assessment tools, based on live evaluations. Intraobserver agreement (between the 2 evaluations) and interobserver agreement (between the 3 evaluators) were both substantial.

Effectiveness of Combining High-Intensity Focused Radiofrequency and Non-Ablative Fractional Laser for Improving the Appearance of the Aging Face and Neck

Background: The safety and effectiveness of high-intensity precision radiofrequency (RF) for rejuvenating the aging neck and face, and of fractional laser therapy for treating photodamaged skin have each been previously demonstrated. Objective: To assess the effects of combining high-intensity precision RF and fractional laser therapy for treating the aging face and neck. Methods and Materials: Subjects (N=19) with Fitzpatrick skin types I to VI and mild-to-moderate solar elastosis and sun or age-related pigmentation on the face and/or neck were sequentially treated with high-intensity precision RF and fractionated laser devices during the same session. Three sessions were completed 30 days apart. Assessments were made 90 days after the last treatment. Results: Both Clinician and Subject Global Assessment of Improvement scores indicated clinical improvement (n=16, 84%) or no change (n=3, 16%) in skin quality. Clinical improvement was also observed in 16 subjects (68%) in masked assessment. Most subjects (90%) noted improved skin quality and 74% expressed at least some satisfaction with their treatment results. The most common adverse events were erythema (n=57, 45%) and edema (n=45, 35%). Conclusion: The results of this study establish the safety and effectiveness of combined treatment with a 1927 nm thulium laser and a high-intensity precision RF device. ClinicalTrials.gov Identifier: NCT03409965. J Drugs Dermatol. 2019;18(1):59-64.

A Double-Blind Randomized Controlled Trial Evaluating the Efficacy and Tolerability of a Topical Body Treatment in Combination With Cryolipolysis Procedures

Background: Non-surgical fat reduction through cold application, cryolipolysis, is an extremely popular procedure. Apoptosis of the fat cell content may take around 3 months to resolve. Objective: A topical test product was compared to a bland emollient as an adjunct to the cryolipolysis procedure of the upper arms to determine if the product could hasten outcomes in these patients. The product includes a peptide combination thought to stimulate autophagic breakdown of lipid droplets, thus speeding up the apoptotic process seen after cryolipolysis. Methods: A randomized, double-blind, comparator-controlled study in 11 patients compared the test product to a bland emollient on the upper arms of patients following cryolipolysis. Subjects were followed at 1, 4, 8, 12, and some at 24-weeks post treatment. Assessments were made through subjective and objective photographic analysis of the treated areas comparing changes in both arms. Results: The test product appeared to speed up the process of contour improvement with results at 8 weeks matching those attained at 12 weeks by the comparator and long-term results at 24 weeks appearing to maintain this advantage. When measured objectively using pixel analysis, 8 and 24-week contour improvement was statistically better than the comparator. Skin laxity was also improved. In additional assessments using 3D volume analysis, cases showed improved reduction of fat tissue on the treated sides. Conclusion: This pilot study introduces a potential advance in adjuvant topical therapy aiding the outcome of non-invasive fat reduction procedures. J Drugs Dermatol. 2019;18(4):342-348.

Nonsurgical Chin and Jawline Augmentation Using Calcium Hydroxylapatite and Hyaluronic Acid Fillers.

The shape of the jawline from the mandibular angle to its most forward point at the chin has a profound effect on an individual's appearance and is an area of concern for many seeking esthetic procedures. Dermal filler injections alone or in combination with other modalities, such as skin tightening energy devices, allow enhancement of the jawline while avoiding the need for surgical procedures. The authors introduce new anatomical zones and nomenclature to enhance safety and outcome when enhancing the jawline. Cadaver dissections were performed to better understand landmarks and potential risks and a topographic guide proposed to assist clinicians to create an esthetically pleasing jawline. Techniques for jawline rejuvenation with calcium hydroxylapatite (CaHA) and high G prime hyaluronic acid (HA) fillers are described. When considered as an esthetic unit, the jawline can be broken down into masseteric, buccal, and mental zones, each with their own injection protocols and safety considerations. Dermal fillers suitable for jawline rejuvenation include either CaHA with or without integral lidocaine, a high G prime HA filler, or a hybrid mixture of CaHA and HA, depending on the desired esthetic outcome and the individual's needs. Small volumes of product per injection point achieve the most natural esthetic outcome and minimize serious adverse events. With these techniques, the angle of the mandible is better defined, the pre- and postjowl hollows are filled, and as a result the jawline appears visibly straighter. CaHA and high G prime HA fillers are effective nonsurgical treatments for redefining the mandibular angle and straightening the contour of the jaw. For optimal results, the jawline should be considered as an esthetic unit and careful consideration paid to anatomical landmarks that influence efficacy and safety.

Comparative compositional analysis of transgenic potato resistant to potato tuber moth (PTM) and its non-transformed counterpart.

In this study, the compositions of transgenic potatoes (TPs) resistant to potato tuber moth (Phthorimaea operculella) were compared with those of its non-transgenic (NTP) counterparts. The light inducible promoter, phosphoenolpyruvate carboxylase led to the expression of Cry1Ab only in the leaves and light-treated tubers of the TPs. No significant differences were found in the moisture, ash, dry weight, total soluble protein, carbohydrate, starch, fiber, ascorbate, cations, anions, fatty acids, and glycoalkaloids contents of TP and NTP. Moreover, light treatment significantly affected the contents of ascorbate, acetate and nitrite anions, palmitic, stearic and linolenic fatty acids, α-haconine and α-solanine glycoalkaloids in TP and NTP tubers. While, significant differences were observed in the amino acid contents in light-treated tubers of TPs than the NTP ones. Although, light treatment in potato tubers resulted in marked metabolic changes, all the variations observed in the metabolites compositions were found to be within the desired reference ranges for potato plants. In conclusion, the results indicated that the TPs were substantially and nutritionally equivalent to the NTP counterparts.

Calcium Hydroxylapatite Dermal Filler for Treatment of Dorsal Hand Volume Loss: Results From a 12-Month, Multicenter, Randomized, Blinded Trial.

BACKGROUND: Calcium hydroxylapatite (CaHA) microspheres suspended in a carrier gel is an opaque dermal filler that has been used to provide immediate volume correction in the dorsal hands. OBJECTIVE: To assess the safety and effectiveness of CaHA for the correction of volume loss in the hands up to 12 months. MATERIALS AND METHODS: This multicenter, controlled, single-blind study (NCT01832090) included 114 subjects randomized 3:1 to CaHA treatment and untreated control groups. Effectiveness was assessed by blinded investigators using the validated Merz Hand Grading Scale (MHGS). Subject-reported improvement was assessed using the Global Aesthetic Improvement Scale. Effects of treatment on hand function were also assessed. RESULTS: A total of 75% of subjects achieved ≥1-point improvement on the MHGS (p < .0001) at 3 months (primary end point); this response was generally maintained through 12 months. Proportions of subjects reporting improvement ranged from 98% (3 months) to 86% (12 months). There were no clinically significant differences between control and CaHA-treated subjects in any hand function measure. Adverse events were generally expected, minor, short-lived, injection-related, and similar to those observed in previous CaHA clinical studies. CONCLUSION: Treatment with CaHA results in significant improvement in the appearance of the dorsal hand and is well tolerated.

Effectiveness and Safety of Large Gel Particle Hyaluronic Acid With Lidocaine for Correction of Midface Volume Deficit or Contour Deficiency.

BACKGROUND: Aging effects, such as facial flatness, increased tissue laxity, and soft tissue descent and deflation, contribute to midface deficiency. OBJECTIVE: To evaluate whether large gel particle hyaluronic acid with lidocaine (LGP-HAL) is more effective in the treatment of midface deficiencies than no treatment. MATERIALS AND METHODS: Subjects with mild to substantial loss of midface fullness were randomized 3:1 to LGP-HAL (Restylane Lyft; Galderma Laboratories, L.P., Fort Worth, TX) or no treatment. Treatment success was defined as at least 1-grade improvement in Medicis Midface Volume Scale (MMVS) on each side of the face at 8 weeks as assessed by a blinded evaluator. Secondary efficacy end points included MMVS score, global aesthetic improvement, and subject satisfaction. RESULTS: Significantly greater percent of subjects achieved treatment success in the LGP-HAL group compared to no treatment at all time points through Month 12 (p < .001). One year after initial treatment, 85% of subjects still had a global aesthetic improvement assessed by the treating investigator. Subject satisfaction demonstrated that LGP-HAL improved the aesthetic appearance of the midface. Most reported adverse events (80%) were mild in severity. CONCLUSION: The LGP-HAL treatment is well tolerated and provides significant improvement up to 12 months for the correction of midface deficiencies.

Selective Non-contact Field Radiofrequency Extended Treatment Protocol: Evaluation of Safety and Efficacy.

BACKGROUND AND OBJECTIVE: Currently there are many non-invasive radiofrequency (RF) devices on the market that are utilized in the field of aesthetic medicine. At this time, there is only one FDA cleared device on the market that emits RF energy using a non-contact delivery system for circumferential reduction by means of adipocyte disruption. Innovation of treatment protocols is an integral part of aesthetic device development. However, when protocol modifications are made it is important to look at the safety as well as the potential for improved efficacy before initiating change. The purpose of this study was to evaluate the safety and efficacy of a newly designed extended treatment protocol using an operator independent selective non-contact RF device for the improvement in the contour and circumferential reduction of the abdomen and flanks (love handles). METHODS: Twenty-five subjects enrolled in the IRB approved multi-center study to receive four weekly 45-minute RF treatments to the abdomen and love handles. Standardized digital photographs and circumference measurements were taken at baseline and at the 1- and 3-month follow-up visits. Biometric measurements including weight, hydration and body fat were obtained at baseline and each study visit. A subset of 4 subjects were randomly selected to undergo baseline serum lipid and liver-related blood tests with follow-up labs taken: 1 day post-treatment 1, 1 day post-treatment 4, and at the 1- and 3-month follow-up visits. RESULTS: Twenty-four subjects (22 female, 2 male), average age of 47.9 years (30-69 years), completed the study. The data of the twenty-four subjects revealed a statistically significant change in circumference P<.001 with an average decrease in circumference of 4.22cm at the 3-month follow-up visit. Lab values for the subset of 4 subjects remained relatively unchanged with only minor fluctuations noted in the serum lipid values in two of the subjects. Three independent evaluators viewed pre-treatment and 3-month post treatment photographs to determine which photo was the after photo. The evaluators were able to correctly identify the post treatment photos with an 88% accuracy rate. Treatments were well tolerated by all subjects. No study related adverse events were reported. CONCLUSION: This study found that an extended treatment protocol using a selective RF device is a safe and effective method for the reduction of circumference and improved contouring of the abdomen and love handles.