Validation of a Photonumeric Assessment Scale for Grading the Slope of the Asian Forehead.

Background: As the number of aesthetic treatments has grown, so have the number of photonumeric assessment scales used to compare the effectiveness of these aesthetic treatments in specific anatomical areas; however, these are primarily based on Caucasian features.

Objective: To assess the validity of the first aesthetic scale for assessing the slope of the Asian forehead. A secondary objective was to correlate this scale with subject demographics and baseline characteristics.

A Validated Assessment Scale for Asian Chin Projection.

Background: As the number of different aesthetic treatments increase, numerous photonumeric assessment scales have been developed and validated to measure the effectiveness of these new treatments and techniques. Photonumeric rating scales have been developed to objectively assess improvements in anatomical areas; however, these have been based on the features of Caucasian patients.

Objective: To develop and validate a Chin Projection Scale for use in the female Asian patient population.

Validated Assessment Scales for the Female Asian Calf.

Background: Clinical photonumeric scales have been developed and validated to objectively measure the effectiveness of aesthetic treatments in specific anatomical areas; however, these are based on the typical features of Caucasian patients. No clinical scale for Asian calf appearance currently exists.

Objective: To develop and validate a calf assessment scale for use in the female Asian patient population.

Durability, Behavior, and Tolerability of 5 Hyaluronidase Products.

Background: Hyaluronic acid (HA) dermal fillers are commonly used in cosmetic dermatology. Due to differences in their physical characteristics, HA fillers demonstrate different sensitivity to degradation by hyaluronidase (Hase) because of HA concentration and differences in cross-linking. Similarly, there are differences in the activity of Hase products depending on source and concentration.

Growing evidence of the beneficial effects of a marine protein-based dietary supplement for treating hair loss.

Background: Hair loss is a common condition among women with a range of causes including nutritional deficiencies.

Aims: To review the clinical data supporting the use of an oral marine supplement designed to promote hair growth.

Patients/methods: Adult women with temporary thinning hair.

A Six-week Low-level Laser Therapy Protocol is Effective for Reducing Waist, Hip, Thigh, and Upper Abdomen Circumference.

Objective: The efficacy of low-level laser therapy for noninvasive body contouring has been previously demonstrated in clinical trials leading to its market clearance. Subjects achieved these beneficial effects following three weekly low-level laser therapy treatments for two weeks. The objective of this study was to determine if the same aesthetic benefit can be achieved following one weekly low-level laser therapy treatment for six weeks.

Combining Microfocused Ultrasound With Botulinum Toxin and Temporary and Semi-Permanent Dermal Fillers: Safety and Current Use.

Background: A microfocused ultrasound system with visualization (MFU-V) is currently indicated for use as a noninvasive dermatological aesthetic treatment to lift the eyebrows, lax submental and neck tissue, and improve lines and wrinkles of the décolleté.

Objective: To determine the existence of any safety signals when combining MFU-V with botulinum toxin-A and/or semipermanent and temporary dermal fillers.

Materials And Methods: A retrospective chart review was performed using subjects who received aesthetic treatments including incobotulinumtoxinA injection, cohesive polydensified matrix hyaluronic acid (CPM HA) dermal fillers, and calcium hydroxylapatite (CaHA) dermal fillers within 6 months of treatment with MFU-V in the same or different anatomic areas.

The Safety and Efficacy of a Sustainable Marine Extract for the Treatment of Thinning Hair: A Summary of New Clinical Research and Results from a Panel Discussion on the Problem of Thinning Hair and Current Treatments.

Alopecia and thinning hair are highly prevalent conditions affecting a large proportion of men and women. Diffused hair loss is often more difficult to diagnose in women, mostly due to over-reliance on the assumption of hormonal influences, and it is commonly treated with a multi-therapy approach. Clinical studies have demonstrated the effectiveness of a nutraceutical supplement to provide essential nutrients that aid in stimulating existing hair growth and reducing hair shedding.

Safety and Efficacy of Microfocused Ultrasound in Tightening of Lax Elbow Skin.

Background: With the increased popularity of minimally invasive cosmetic treatments, this study evaluates the efficacy and safety of microfocused ultrasound with visualization (MFU-V) for tightening lax skin above the elbow.

Methods: Subjects were treated bilaterally above the elbows with MFU-V using transducers with different focal depths. Photographs were taken before treatment and at 90- and 180-day follow-ups.

Multicenter pivotal study of vacuum-assisted precise tissue release for the treatment of cellulite.

Background: Cellulite refers to the dimpled appearance of skin occurring where the dermis is tethered by subcutaneous fibrous septa arranged perpendicularly to the skin surface.

Objective: To demonstrate the safety and efficacy of a new system for vacuum-assisted precise tissue release for the treatment of cellulite.

Materials And Methods: Adult women with moderate to severe cellulite (N = 55) underwent a single treatment.

A prospective multicenter pilot study of the safety and efficacy of microfocused ultrasound with visualization for improving lines and wrinkles of the décolleté.

Background: A previous pilot study demonstrated microfocused ultrasound with visualization (MFU-V) to lift and tighten the décolleté produced significant and durable aesthetic improvements.

Objective: To further evaluate the safety and effectiveness of MFU-V for improving lines and wrinkles of the décolleté in a larger patient population.

Materials And Methods: Healthy women with moderate-to-severe décolleté skin lines and wrinkles were enrolled.

Safety and efficacy of RT002, an injectable botulinum toxin type A, for treating glabellar lines: results of a phase 1/2, open-label, sequential dose-escalation study.

Background: RT002 is a new injectable BoNTA product. This formulation limits the spread of BoNTA, potentially permitting safe administration of larger doses and possibly extending its duration of action.

Objective: This phase 1/2 clinical study was designed to establish the safety of RT002 for the treatment of moderate-to-severe glabellar lines.

Safety and efficacy of microfocused ultrasound to lift, tighten, and smooth the buttocks.

Background: Microfocused ultrasound has been shown to lift and tighten lax eyebrows, submental, and neck skin.

Objective: The aim of this study was to evaluate the safety and effectiveness of microfocused ultrasound to lift, tighten, and smooth the buttocks.

Materials And Methods: Thirty-one subjects, with buttock skin laxity, were entered into the study.

Persistence of nasolabial fold correction with a hyaluronic acid dermal filler with retreatment: results of an 18-month extension study.

Background: An 18-month persistence study reported nasolabial fold (NLF) improvements using a small gel-particle hyaluronic acid (SGP-HA) dermal filler lasted up to 18 months after one retreatment.

Objective: [corrected] To evaluate the efficacy and persistence of SGP-HA for the correction of NLFs for up to 36 months.

Methods & Materials: Subjects completing the 18-month persistence study were permitted to enroll in an 18-month extension trial.

Extended-release fluvoxamine and improvements in quality of life in patients with obsessive-compulsive disorder.

Objective: We hypothesized that subjects with obsessive-compulsive disorder (OCD) who received extended-release fluvoxamine (fluvoxamine ER) in a 12-week placebo-controlled trial would exhibit improvements in psychosocial domains of health-related quality of life (HRQOL) and that additional improvements would occur after a 40-week open-label extension trial. We also hypothesized that greater OCD symptom improvement in the first 12 weeks of treatment would be associated with greater HRQOL improvement after 52 weeks of treatment.

Methods: In the 12-week placebo-controlled trial, subjects were randomized to receive placebo or 100 mg/d of fluvoxamine ER and then titrated in weekly 50 mg increments to a final dose of 100 to 300 mg/d.

Relative bioavailability of sapropterin from intact and dissolved sapropterin dihydrochloride tablets and the effects of food: a randomized, open-label, crossover study in healthy adults.

Background: Phenylketonuria (PKU) is an autosomal recessive metabolic disorder characterized by hyperphenylalaninemia in association with neurocognitive and neuromotor impairment. Sapropterin dihydrochloride (hereafter referred to as sapropterin) administered orally as dissolved tablets is approved by the US Food and Drug Administration for hyperphenylalaninemia in patients with tetrahydrobiopterin responsive PKU.

Objectives: This study compared the relative oral bioavailability of sapropterin when administered as intact and dissolved tablets.

The nightly administration of sodium oxybate results in significant reduction in the nocturnal sleep disruption of patients with narcolepsy.

Background: Previous studies indicate that nightly sodium oxybate administration reduces nocturnal sleep disruption in narcolepsy. The present study provided an opportunity to further characterize these sleep-related effects in patients with narcolepsy during treatment with sodium oxybate as monotherapy or in combination with modafinil.

Methods: This double-blind, placebo-controlled study enrolled 278 patients with narcolepsy taking modafinil 200-600 mg daily for the treatment of excessive daytime sleepiness (EDS).

Exacerbation of cataplexy following gradual withdrawal of antidepressants: manifestation of probable protracted rebound cataplexy.

Background: A double-blind, placebo-controlled sodium oxybate trial provided a unique opportunity to compare changes in cataplexy following gradual withdrawal from antidepressants in narcolepsy patients.

Methods: Of 228 enrolled patients, 71 discontinued antidepressant therapy. Data from 57 patients were available for analysis: 37 patients discontinued tricyclic antidepressants (TCAs) and 20 discontinued selective serotonin reuptake inhibitors (SSRIs).

The clinical development of gamma-hydroxybutyrate (GHB).

The discovery of gamma-hydroxybutyrate (GHB) over 40 years ago led to its immediate use as a general anesthetic agent. Subsequent research demonstrated that GHB is an endogenous compound in the mammalian brain and current research suggests that GHB is a probable neurotransmitter. In the United States, reports of anabolic effects lead to its misuse among body builders during the 1980's while the intoxicating properties of the drug lead to its popularization as a substance of abuse during the 1990's.

The Xyrem risk management program.

Sodium oxybate, also known as gamma-hydroxybutyric acid (GHB), was discovered in 1960 and has been described both as a therapeutic agent with high medical value and, more recently, a substance of abuse. The naturally occurring form of this drug is found in various body tissues but has been studied most extensively in the CNS where its possible function as a neurotransmitter continues to be studied. Sodium oxybate has been approved in different countries for such varied uses as general anaesthesia, the treatment of alcohol withdrawal and addiction, and, most recently, cataplexy associated with narcolepsy.

From club drug to orphan drug: sodium oxybate (Xyrem) for the treatment of cataplexy.

Narcolepsy, a rare disease with a prevalence of 0.05% in the general population, affects an estimated 140,000 patients in the United States. Patients have been able to lead fuller personal and professional lives since the Food and Drug Administration approved sodium oxybate (Xyrem) in 2002 for treatment of cataplexy in patients with narcolepsy.