PrabotulinumtoxinA vs OnabotulinumtoxinA for the Treatment of Adult Males With Moderate to Severe Glabellar Lines: Post-hoc Analyses of the Phase III Clinical Study Data.

BACKGROUND: Despite a growing interest among men in cosmetic procedures such as botulinum toxin, comparator clinical trial data in this population are limited. OBJECTIVES: The authors sought to compare the efficacy and safety of prabotulinumtoxinA and onabotulinumtoxinA for the treatment of males with moderate to severe glabellar lines. METHODS: Post-hoc analyses were performed on the subpopulation of male patients treated with either a single dose of 20 U prabotulinumtoxinA (n = 25) or 20 U onabotulinumtoxinA (n = 31) in the EVB-003 Phase III glabellar line clinical study. One key efficacy endpoint was the proportion of responders with a ≥1-point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale. RESULTS: Compared with onabotulinumtoxinA-treated males, the percentages of responders who had a ≥1-point improvement on the Glabellar Line Scale at maximum frown were higher at all postbaseline time points for prabotulinumtoxinA-treated males (P > 0.05 at all visits) by an absolute overall mean difference of 10.1% across all visits. Similar trends were observed for efficacy endpoints based on global aesthetic improvement and subject satisfaction. PrabotulinumtoxinA-treated males had a higher incidence of treatment-related headache and eyelid ptosis. CONCLUSIONS: The percentages of patients who met the definition of a responder were higher at almost all time points examined for prabotulinumtoxinA-treated males. Despite the high level of consistency across all measures, differences between the 2 treatment groups did not reach statistical significance. Further study is warranted to establish if these post-hoc analyses observations are reproducible in a larger male patient population.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the efficacy and safety of prabotulinumtoxinA compared to onabotulinumtoxinA and placebo for the treatment of glabellar lines. METHODS: This was a 150-day, multicenter, double-blind, controlled, single-dose Phase III study. Adult patients (n = 540) with moderate to severe glabellar lines at maximum frown as assessed by the investigator on the validated 4-point Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), who also felt that their glabellar lines had an important psychological impact, were enrolled. Patients were randomized 5:5:1 to receive a single treatment (0.1 mL injected into each of 5 glabellar sites) of 20 U prabotulinumtoxinA (n = 245), 20 U onabotulinumtoxinA (n = 246), or placebo (n = 49). The primary efficacy endpoint was the proportion of responders (patients with a Glabellar Line Scale score of 0 or 1 at maximum frown by investigator assessment) on day 30. RESULTS: Responder rates for the primary efficacy endpoint were 87.2%, 82.8%, and 4.2% in the prabotulinumtoxinA, onabotulinumtoxinA, and placebo groups, respectively. The absolute difference between prabotulinumtoxinA and onabotulinumtoxinA groups was 4.4% (95% confidence interval [-1.9, 10.8]). Given that the lower bound of the 95% confidence interval for the difference was less than -10.0%, noninferiority of prabotulinumtoxinA vs onabotulinumtoxinA was concluded. Five patients (3 prabotulinumtoxinA, 1.2%; 1 onabotulinumtoxinA, 0.4%; 1 placebo, 2.0%) experienced serious adverse events, none of which were study drug related. CONCLUSIONS: A single treatment of 20 U prabotulinumtoxinA was safe and effective and noninferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines.

Bio-Dermal Restoration With Rapidly Polymerizing Collagen: A Multicenter Clinical Study.

BACKGROUND: Despite the increasing popularity of facial contouring with hyaluronic acid, innovation has been limited to iterations that feature different particle sizes, concentrations, and degrees of crosslinking. Bio-dermal restoration is a new approach for correcting facial tissue defects by supplementing the natural dermal structure providing a scaffold for fibroblast adherence and proliferation. OBJECTIVES: The purpose of the study was to evaluate the safety of RPC Pure-Collagen for the treatment of facial contours. METHODS: A prospective, multicenter, open-label study in 30 patients treated with RPC Pure-Collagen in the nasolabial fold and followed up to 12 weeks after injection. A subset of patients was further followed up to 9 months after treatment. RPC Pure-Collagen is a sterile, nonpyrogenic, viscous, clear solution composed of pure porcine collagen ethylenediamine tetraacetic acid (EDTA) and Mannitol that can be injected through a 30 gauge needle as a liquid and fibrilizes in situ forming a natural, open 3-dimensional collagen matrix for bio-dermal restoration. RESULTS: No treatment related adverse events were noted in addition to transient injection site reactions typical to injection procedures, which were mild or moderate in severity except for one case of severe bruising. There were no reports of hypersensitivity, supporting that RPC Pure Collagen does not require skin testing prior to treatment. Performance results showed a significant improvement from baseline upon treatment, and at the end of the study, on both the Merz Aesthetic Scale and the Global Aesthetic Improvement Scale assessments. CONCLUSIONS: This initial study shows that RPC Pure-Collagen is safe for its use in facial contouring and provides good indication for long-term safety. Bio-dermal restoration with RPC Pure-Collagen holds promise as safe, lasting, and natural facial contouring treatment.

A Two-Phase Pilot Study to Evaluate the Safety and Tolerability of an In Situ Polymerizing Collagen.

BACKGROUND: Demand for collagen-based fillers has declined primarily because of limited long-term clinical benefit and the introduction of hyaluronic acid compositions. In situ polymerizing collagen is a noncrosslinked solution of porcine collagen containing a collagenase shield that undergoes fibrillogenesis on injected into tissues forming a natural matrix. OBJECTIVE: Conduct a prospective, single-center, dual-phase open-label study in 8 subjects to evaluate the safety, tolerability, and efficacy of the porcine collagen composition. METHODS: In Phase I, potential hypersensitivity of the collagen composition was evaluated after skin testing in the back (men) or forearms of subjects (women). In Phase II, subjects showing no signs of hypersensitivity received collagen injections into the nasolabial area followed by evaluation at 1, 4, 8, and 12 weeks using the Global Aesthetic Improvement Scale. RESULTS: None of the subjects had signs of hypersensitivity and all continued in Phase II. The treating physician(s) reported no post-treatment adverse events. Improvement of the nasolabial fold was observed by the physicians and confirmed by assessment of high-resolution photographs and Global Aesthetic Improvement Scale scores over the 12-week treatment were maintained. CONCLUSION: In this pilot clinical study in situ polymerizing collagen was shown to be safe and effective throughout the 3-month study period.

Radiological assessment of the breast following enhancement with Macrolane: Managing the challenges.

Macrolane VRF®, a biodegradable, stabilized hyaluronic acid gel, was used for breast enhancement 2008-2012. Similar to permanent implants, the presence of Macrolane gel may interfere with interpretation of mammography. This short communication aims to provide a guide to the appearance of Macrolane on radiology examination (including mammography, ultrasound and magnetic resonance imaging) and aid selection of the most appropriate imaging modality to facilitate breast examination in women who have undergone Macrolane breast enhancement.

Efficacy and Safety of IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results From a Randomized, Double-Blind, Placebo-Controlled, Phase III Study.

BACKGROUND: Treating upper facial lines (UFL)-a combination of glabellar frown lines (GFL), horizontal forehead lines (HFL), and lateral periorbital lines (LPL)-is a common aesthetic practice. OBJECTIVE: To provide the first placebo-controlled evidence of the efficacy and safety of incobotulinumtoxinA for UFL. METHODS: Healthy subjects (≥18 years) with moderate-to-severe GFL, HFL, and LPL on the Merz Aesthetics Scales (MAS) at maximum contraction were randomized to incobotulinumtoxinA or placebo. For incobotulinumtoxinA, 54 to 64 U were administered (GFL, 20 U; HFL, 10-20 U; LPL, 24 U). Investigator-assessed MAS scores were evaluated for each area at maximum contraction on Day 30, both separately (responder = score of "none" [0] or "mild" [1]) and combined (UFL; sum score ≤3). Adverse events were recorded until 120 ± 7 days after treatment. RESULTS: Overall, 156 subjects were treated (incobotulinumtoxinA: 105; placebo: 51). On Day 30 at maximum contraction, a significant (p ≤ .0001) effect of incobotulinumtoxinA versus placebo for GFL (84.5% vs 0.0%, respectively), HFL (70.9% vs 2.1%), LPL (64.1% vs 2.1%), and UFL combination (55.3% vs 0.0%) was demonstrated for investigator-assessed "none" or "mild" scores. Two cases of mild eyelid ptosis occurred with incobotulinumtoxinA. CONCLUSION: IncobotulinumtoxinA demonstrated significant efficacy in treating GFL, HFL, and LPL separately and combined, as well as a good safety profile.

Early clinical experience of hyaluronic acid gel for breast enhancement.

BACKGROUND: An increasing number of women are seeking minimally-invasive procedures to enhance the shape and volume of their breasts. Early, limited use of Macrolane™ suggests it is a promising agent for non-surgical breast enhancement. OBJECTIVE: To assess the safety and efficacy of Macrolane™ in non-surgical breast enhancement. METHODS: A prospective report of 194 women presenting for non-surgical breast enhancement at London Bridge Plastic Surgery between November 2007 and August 2009. SAFETY: Adverse events were reported in a total of 21.1% of patients. Minor adverse events (12%) were mainly confined to product migration, lumpiness, scar pigmentation and breast pain. All events were of mild to moderate intensity and resolved promptly without any additional treatment. Major adverse events (8.7%) included infection, capsular contracture, early resorption and product removal. EFFICACY: EFFICACY of treatment was assessed by patients using the five-point Global Esthetic Improvement Scale (GEIS). Patient satisfaction with treatment was consistently high with a mean score≥3.3 at all time points during follow-up. Patient-assessed GEIS indicated that some degree of improvement was seen by all (100%) patients at all time points up to and including 12 months irrespective of whether they had been re-treated. At the time of analysis, follow-up data are available for 45% of patients at 12 months, with 19% of all patients presenting for re-treatment with Macrolane™ to date and 5.7% going on to have breast implants. CONCLUSION: This review represents the largest European clinical experience with Macrolane™ for breast enhancement. It shows that Macrolane™ can provide satisfactory improvement in breast shape. It is associated with high patient satisfaction, and provides a long-lasting result. Follow-up to data have been adequate to identify early complications; however, further follow-up is required to monitor long-term outcomes. The impact of HA on breast cancer remains inconclusive to date.

Nonsurgical hand rejuvenation with Dermicol-P35 30G.

Aesthetic hand rejuvenation and restoration have been relatively overlooked compared with other aesthetic enhancements. Cosmetic dermal fillers provide physicians and patients with a nonsurgical option for restoring volume and a youthful appearance to the aging and damaged hand. This paper presents the clinical experience of patients who received Dermicol-P35 30G (Evolence Breeze; Ortho Dermatologics, Skillman, NJ) injection for rejuvenation and restoration of the hand.

Autologous cell therapy: current treatments and future prospects .

Autologous cell therapy (ACT) is a novel therapeutic intervention that uses an individual's cells, which are cultured and expanded outside the body, and reintroduced into the donor. Advantages of such an approach include the minimization of risks from systemic immunological reactions, bio-incompatibility, and disease transmission associated with grafts or cells not cultivated from the individual. So far, this form of therapy has been used successfully to bioengineer skin substitutes, aid wound healing, counteract chronic inflammation, treat burns and pressure ulcers, and improve postoperative healing. The authors will review the promising outcomes of various therapeutic interventions using ACT, as well as the concerns raised with using explanted material, and any potential alteration through the cultivation process. This review will discuss its role in assisting the healing process of conditions such as a damaged myocardium, developing hyaline cartilage, and in the treatment of neurodegenerative diseases and other ailments that benefit from the immediate availability of a donor. The use of ACT for cosmetic enhancement or corrective surgery is also gaining recognition as a creditable form of treatment and has been shown to reduce the risk of rejection and to have longer lasting effects than conventional treatments. This form of treatment is under intense investigation with the hope that it will eventually be able to replace conventional forms of plastic surgery to improve the repair process of aging or damaged tissues. .