Efficacy, patient-reported outcomes and safety profile of ATX-101 (deoxycholic acid), an injectable drug for the reduction of unwanted submental fat: results from a phase III, randomized, placebo-controlled study.

BACKGROUND: Unwanted submental fat (SMF) may result in an unattractive chin profile and dissatisfaction with appearance. An approved and rigorously tested non-surgical method for SMF reduction is lacking. OBJECTIVE: To evaluate the efficacy and safety of ATX-101 for the pharmacological reduction of unwanted SMF in a phase III randomized, double-blind, placebo-controlled study. METHODS: Patients (n = 360) with moderate or severe SMF were randomized to receive ATX-101 1 or 2 mg/cm(2) or placebo injected into their SMF for up to four treatments ~28 days apart, with a 12-week follow-up. Coprimary efficacy endpoints were the proportions of treatment responders, defined as a ≥1-point reduction in SMF on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS), and those satisfied with their appearance in association with their face and chin after treatment on the Subject Self-Rating Scale (SSRS score ≥4). Secondary efficacy endpoints included a ≥1-point improvement in SMF on the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) and changes in the Patient-Reported Submental Fat Impact Scale (PR-SMFIS). Additional patient-reported outcomes and changes in the Skin Laxity Rating Scale were recorded. Adverse events (AEs) and laboratory test results were monitored. RESULTS: Compared with placebo, a greater proportion of patients treated with ATX-101 1 and 2 mg/cm(2) showed a ≥1-point improvement in CR-SMFRS (58.3% and 62.3%, respectively, vs. 34.5% with placebo; P < 0.001) and patient satisfaction (SSRS score ≥4) with the appearance of their face and chin (68.3% and 64.8%, respectively, vs. 29.3%; P < 0.001). Patient-reported secondary efficacy endpoints showed significant improvements in SMF severity (PR-SMFRS; P = 0.009 for ATX-101 1 mg/cm(2) , P < 0.001 for ATX-101 2 mg/cm(2) vs. placebo) and emotions and perceived self-image (PR-SMFIS; P < 0.001). No overall worsening of skin laxity was observed. AEs were mostly transient, mild to moderate in intensity and localized to the treatment area. CONCLUSION: ATX-101 was effective and well tolerated, and may be an alternative to surgery for patients desiring improvement of their submental profile.

International consensus recommendations on the aesthetic usage of botulinum toxin type A (Speywood Unit)--Part II: Wrinkles on the middle and lower face, neck and chest.

BACKGROUND: Azzalure® (Galderma SA), a newly approved European botulinum neurotoxin type A (BoNT-A), is derived from Dysport™ (Ipsen Ltd.), which has a 20-year history of product consistency and has been widely used for various aesthetic and therapeutic applications. Azzalure® and Dysport™ are collectively referred to as BoNT-A (Speywood Unit) after the unit of their activity, and are distinct from other commercial BoNT-A preparations. Consensus has been developed for the treatment of upper facial wrinkles with BoNT-A (Speywood Unit). OBJECTIVE: To provide consensus recommendations on the treatment with BoNT-A (Speywood Unit) for wrinkles on the middle and lower face, neck and chest region. METHODS: The members of the International Board on Botulinum toxin Azzalure (IBBA) convened to develop consensus based on their extensive experience. RESULTS: The recommended final concentration of BoNT-A (Speywood Unit) is 200 Speywood Units/ml after reconstitution. The consensus recommendations were provided for nine indications, including lower eyelid wrinkles, bunny lines, drooping nasal tip, perioral wrinkles, masseter hypertrophy, drooping mouth corners, dimpled chin, platysmal bands and décolleté wrinkles. For each indication, anatomy of the region to be treated was discussed, as were potential side-effects. The consensus recommendations included the number and location of the injection points, dose range of each point and the total injection, as well as specific injection technique. CONCLUSION: These recommendations provide a guideline for physicians who wish to perform safe and efficacious treatment with BoNT-A (Speywood Unit) on the less commonly treated middle and lower face, neck and chest region.

[Treatment of HIV facial lipoatrophy with a submalar porous polyethylene implant (Medpor)]. / Traitement des lipoatrophies faciales utilisant des implants de Medpor en polyéthylène poreux.

Human immunodeficiency virus associated facial lipoatrophy is becoming epidemic and is a distressing sign for patients. Non permanent fillers provide only temporary results and cannot be the solution for severe cases. Lipodystrophy makes the lipofilling difficult to perform with a fibrous low quality fat difficult to harvest. We propose another solution using porous polyethylene implants (Medpor). Eight patients underwent submalar augmentation through an upper gingivobuccal sulcus incision that allows a subperiosteal dissection. The implants are carved to provide the desired augmentation. Overall, eight patients had good or very good aesthetic postoperative outcomes as determined by the patient and the surgeon. No complications occurred and results remain natural. Porous polyethylene implant (Medpor) is our treatment of choice for mild to severe facial lipoatrophy. Besides these implants could be removed easily later if needed.

[Botulinum toxin and wrinkles: few side effects and effective combining procedures with other treatments]. / Toxine botulique et rides: peu d'effets secondaires, et des associations thérapeutiques performantes.

Chemical denervation, through the biologic effect of botulinum toxin, provides a very effective, low risk, lasting treatment for hyperkinetic wrinkles, mainly of the upper face. Patients with such rhytides, when treated with surgical myotomies or other alternative medical treatments, are at greater risk and with potentially less lasting results. Botulinum toxin has been widely used for the last 20 years in many areas of medicine. It has been used for 13 years in dermatology and plastic surgery, without important complications or sequellae. Any complications appear to be reversible. In these two specialties, with the minute quantities (units) and volume of material injected, complications are infrequent; some of them are now anecdotal. The only main complication from a cosmetic point of view is blepharoptosis, which is more and more rare. Because of a better anatomical knowledge of the affected muscles, and our improved technique, risks are greatly reduced. In our two latest multicenter studies on glabellar wrinkles, between 2002 and 2004, we saw no blepharoptosis. Conversely, in case of dynamic wrinkles associated with muscle, fat, and skin relapse, and/or deep furrows, only surgical procedures and/or other surface treatments are effective. Botulinum toxin injections are not meant to replace upper, mid, or mandibular face and neck lifts; indeed, botulinum toxin injections may optimize results from these surgical procedures. These injections play a fundamental process in producing long lasting results. The current and future evolution, in cosmetic surgery, is toward full achieved, but focused, natural, and minimally invasive surgical procedures in combination with effective and minimal risk techniques such as the botulinum toxin injections. To optimize the effect of the medical procedures, botulinum toxin should be injected three weeks before surgery. In addition botulinum toxin injections may optimize and prolong the effect of the surface procedures, as lasers, peels and fillers. This medicosurgical combination is one of the examples that best describes the evolution of plastic and aesthetic surgery in 2004.