Dermal fillers: an update.

Injection of dermal fillers is the second most frequent nonsurgical cosmetic procedure performed in the USA. Dermal fillers are an option in the treatment of volume deficiency, scars, and rhytides; facial sculpting; facial contouring; and augmentation of specific anatomical sites such as the lips. The number of injectable dermal fillers available on the market increases yearly.

Efficacy of incobotulinumtoxinA for treatment of glabellar frown lines: a post hoc pooled analysis of 2 randomized, placebo-controlled, phase 3 trials.

Background: Botulinum neurotoxin type A trials in aesthetic indications have used differing efficacy parameters and responder definitions.

Objective: To analyze the treatment efficacy and duration of incobotulinumtoxinA for glabellar frown lines using pooled data from 2 large, Phase 3, placebo-controlled trials, and end points similar to those used in previous botulinum neurotoxin type A studies.

Materials And Methods: IncobotulinumtoxinA and placebo groups comprised 366 and 181 subjects, respectively.

Long-term efficacy, safety and durability of Juvéderm® XC.

Over the last decade, there has been increasing interest in minimally invasive cosmetic treatments, especially for facial rejuvenation. Next to botulinum toxin injection, the injection of soft tissue fillers is the second most frequent minimally invasive procedure performed in the USA. Hyaluronic acid (HA) is the most commonly used dermal filler.

A randomized, placebo-controlled, double-blind phase III trial investigating the efficacy and safety of incobotulinumtoxinA in the treatment of glabellar frown lines using a stringent composite endpoint.

Background: A prospective, randomized, double-blind, multicenter, Phase III trial of incobotulinumtoxinA using new Food and Drug Administration endpoints.

Objective: To investigate the efficacy and safety of a single dose of incobotulinumtoxinA for the treatment of glabellar frown lines.

Materials And Methods: Two hundred seventy-one subjects with moderate to severe glabellar frown lines at maximum frown-as assessed by an investigator according to the facial wrinkle scale (FWS)-were randomized 2:1 to receive one treatment of 20 U of incobotulinumtoxinA or placebo, respectively, and assessed over 120 days.

Systematic review of clinical trials of small- and large-gel-particle hyaluronic acid injectable fillers for aesthetic soft tissue augmentation.

Background: Hyaluronic acid (HA) is the most frequently injected filler for soft tissue augmentation in the United States.

Objective: To systematically review published evidence for aesthetic use of small- and large-gel-particle HA.

Methods And Materials: Clinical data on anatomic area, level of evidence, patient population, trial design, endpoints, efficacy, and safety were extracted from PubMed.

A randomized, evaluator-blinded, controlled study of the effectiveness and safety of small gel particle hyaluronic acid for lip augmentation.

Objectives: To assess the effectiveness and safety of small gel particle hyaluronic acid (SGP-HA) for lip augmentation.

Methods: Adults (n = 180; aged 18-65) scoring 1 (very thin) to 2 (thin) on the 5-point validated Medicis Lip Fullness Scale (MLFS) for the upper or lower lip were randomized (3:1) to SGP-HA (≤1.5 mL/lip) or no treatment.

Development and validation of a new clinically-meaningful rating scale for measuring lateral canthal line severity.

Background: Several scales have been employed for evaluating the effects of cosmetic treatments in the periorbital area. The Food and Drug Administration (FDA) has recently issued new recommendations specifying a rigorous process to validate new aesthetic scales.

Objectives: The authors describe and validate a new clinical rating scale: the Investigator's Global Assessment of Lateral Canthal Line (IGA-LCL) severity scale.

Long-term effectiveness and safety of small gel particle hyaluronic acid for hand rejuvenation.

Background: Fillers to reverse the effects of fat atrophy can help restore the hands' youthful appearance.

Objective: To evaluate the effectiveness and safety of small gel particle hyaluronic acid (SGP-HA) for hand rejuvenation through 1 year.

Materials And Methods: A prospective open-label study recruited adults with moderate to severe vascular, bony, and tendon prominence.

Results of a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a botulinum toxin type A topical gel for the treatment of moderate-to-severe lateral canthal lines.

Background: Injections of botulinum toxin type A are commonly used to treat facial wrinkles; however, undesirable effects are associated with injections (e.g., pain, bruising, ptosis, immunogenicity, and needle aversion).

Safety and effectiveness of small and large gel-particle hyaluronic acid in the correction of perioral wrinkles.

Background: FDA-approved for the correction of moderate-to-severe facial wrinkles and folds, small gel-particle hyaluronic acid (SGP-HA, Restylane, Medicis Aesthetics, Inc., Scottsdale, AZ) and large gel-particle hyaluronic acid (LGP-HA, Perlane, Medicis Aesthetics, Inc., Scottsdale, AZ) were studied to evaluate their safety for the correction of oral commissures, marionette lines, upper perioral rhytides and nasolabial folds (NLFs).

Cosmeceuticals: current trends and market analysis.

The desire to maintain a youthful image combined with an emerging global market with disposable income has driven the development of many new industries. The cosmeceutical industry is based on the development and marketing of products that lie between cosmetics and pharmaceuticals. Today, there are over 400 suppliers and manufacturers of cosmeceutical products, and the industry is estimated to grow by 7.

Investigator global evaluations of efficacy of injectable poly-L-lactic acid versus human collagen in the correction of nasolabial fold wrinkles.

Background: Injectable poly-L-lactic acid (PLLA) is indicated in the United States for use in immune-competent patients for correction of shallow-to-deep nasolabial fold contour deficiencies and other facial wrinkles in which a deep dermal grid pattern injection technique is appropriate. It is also indicated for restoration and/or correction of signs of lipoatrophy in patients with human immunodeficiency virus.

Objective: The authors examine the efficacy of injectable PLLA for correction of nasolabial fold wrinkles, based on Investigator Global Evaluations (IGE).

Subject global evaluation and subject satisfaction using injectable poly-L-lactic acid versus human collagen for the correction of nasolabial fold wrinkles.

Background: This is a report of the secondary endpoints, Subject Global Evaluation (overall improvement) and Subject Satisfaction scores, from a study designed to examine the efficacy of injectable poly-L-lactic acid for the correction of nasolabial fold wrinkles over 25 months.

Methods: A randomized, subject-blinded, parallel-group, multicenter clinical study was conducted to compare the effects of injectable poly-L-lactic acid with those of human collagen for the treatment of nasolabial fold wrinkles at 13 months following the last treatment. Injectable poly-L-lactic acid-treated subjects were followed for 25 months.

Efficacy and safety evaluation of a novel botulinum toxin topical gel for the treatment of moderate to severe lateral canthal lines.

Background: Botulinum toxin type A (BoNTA) is commonly injected to treat facial wrinkles. Complications include pain, erythema, bruising, and potential infection. RT001 Botulinum Toxin Type A Topical Gel (RT001) is under development for the treatment of lateral canthal lines (LCLs).

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.

A lidocaine-containing formulation of large-gel particle hyaluronic acid alleviates pain.

Background: Effective pain management is an important component of aesthetic procedures.

Objective: To compare the pain relief and safety of large-gel particle hyaluronic acid (HA) plus 0.3% lidocaine (LGP-HA+L) with that of LGP-HA without lidocaine during correction of nasolabial folds (NLFs) and to assess filler safety in different skin types.

12-Month controlled study in the United States of the safety and efficacy of a permanent 2.5% polyacrylamide hydrogel soft-tissue filler.

Objective: To evaluate the safety and efficacy of a 2.5% polyacrylamide hydrogel in the aesthetic enhancement of nasolabial folds.

Methods And Materials: The safety and efficacy of a polyacrylamide hydrogel were compared with those of nonanimal stabilized hyaluronic acid (NASHA) in 315 subjects in a double-blind, randomized, multicenter, noninferiority trial with a 12-month follow-up.

The effects of BOTOX injections on emotional experience.

Although it was proposed over a century ago that feedback from facial expressions influence emotional experience, tests of this hypothesis have been equivocal. Here we directly tested this facial feedback hypothesis (FFH) by comparing the impact on self-reported emotional experience of BOTOX injections (which paralyze muscles of facial expression) and a control Restylane injection (which is a cosmetic filler that does not affect facial muscles). When examined alone, BOTOX participants showed no pre- to posttreatment changes in emotional responses to our most positive and negative video clips.

An analysis of efficacy data from four phase III studies of botulinum neurotoxin type A-ABO for the treatment of glabellar lines.

Background: A new formulation of a botulinum neurotoxin type A (BoNTA-ABO; Dysport [abobotulinumtoxinA], Medicis Aesthetics, Scottsdale, AZ) has recently been approved in the United States for the treatment of moderate to severe glabellar lines.

Objective: We describe the results of four phase III studies of BoNTA-ABO for the treatment of glabellar lines.

Methods: Of the four studies reported here, three were double-blind, multicenter, randomized, placebo-controlled studies and one was an open-label extension study.

A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles.

Background: Injectable poly-L-lactic acid (PLLA) is a synthetic, biodegradable, biocompatible polymer device.

Objective: We sought to compare the efficacy and safety of injectable PLLA with human-derived collagen in treating nasolabial fold wrinkles.

Methods: In this randomized, evaluator-blinded, parallel-group, multicenter study, subjects received injectable PLLA (n = 116) or collagen (n = 117) injections (1-4 visits, 3-week intervals).

Evaluation of variable-dose treatment with a new U.S. Botulinum Toxin Type A (Dysport) for correction of moderate to severe glabellar lines: results from a phase III, randomized, double-blind, placebo-controlled study.

Background: In April, the U.S. Food and Drug Administration approved a new U.

Randomized, placebo-controlled study of a new botulinum toxin type a for treatment of glabellar lines: efficacy and safety.

Background: A new botulinum toxin type A (BoNT-A) has been assessed in the United States for treatment of glabellar lines. In April 2009, the US FDA approved the Biologics License Application for a new US formulation of BoNT-A (Dysport [abobotulinum toxin A]; Medicis Aesthetics Inc., Scottsdale, AZ).

Twelve-month persistency of a novel ribose-cross-linked collagen dermal filler.

Background: The porcine collagen-derived dermal filler Dermicol-P35 (Evolence, Colbar LifeScience Ltd, Herzliya, Israel) has low immunogenicity and the potential to provide a long-lasting corrective response for soft-tissue contour deficiencies and deformities. OBJECTIVE The objective was to assess the persistence of the corrective response with Dermicol-P35 up to 12 months after obtaining an optimal cosmetic result (OCR) in a randomized, multicenter study comparing the efficacy and safety of Dermicol-P35 with the hyaluronic acid (HA) filler Restylane (Medicis Pharmaceutical Co.).

Hyaluronic acid gel fillers in the management of facial aging.

Time affects facial aging by producing cellular and anatomical changes resulting in the consequential loss of soft tissue volume. With the advent of new technologies, the physician has the opportunity of addressing these changes with the utilization of dermal fillers. Hyaluronic acid (HA) dermal fillers are the most popular, non-permanent injectable materials available to physicians today for the correction of soft tissue defects of the face.