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ABSTRACT: The U.S. Food and Drug Administration has approved four distinct formulations of botulinum toxin (BoNT) serotypes A and B (BoNTA and BoNTB) for medical use. These four products are indicated for many medical applications, but the three BoNTA formulations are the most widely used worldwide and are the only products approved for aesthetic use. The latest approval of a BoNTA with no complexing proteins (incobotulinumtoxinA) necessitates a review and discussion of differences between available formulations and the effect that these differences may have on clinical practice.
To review the history, science, safety information, and current and emerging applications of BoNT in clinical and cosmetic practice and to compare commercially available BoNTA formulations.
Publications, clinical trials, and author experience were used as a basis for an up-to-date review of BoNT and its use in human medicine. The similarities and differences between formulations are presented, and diffusion, spread, equivalency ratios, stability, and storage are discussed.
Each commercial formulation has unique characteristics that may influence its use in aesthetic medicine. Familiarity with the similarities and differences between products will aid physicians in making patient care decisions.
New formulations, emerging uses, and continued research into the science and uses of BoNTA will lead to increasingly refined therapeutic approaches and applications. Continued education is important for physicians to optimize use of the agent according to the most current evidence and approaches.
Dermatologic Surgery 03/2013; 39(3 Pt 2):493-509. · 1.80 Impact Factor
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Alastair Carruthers,
Jean Carruthers,
William P Coleman,
Lisa Donofrio,
Timothy Flynn,
Michael Gold,
Moritz Heinz,
Laura Harrington,
Derek Jones,
David McDaniel,
Thomas Rohrer,
Andrea Schlöbe,
Nowell Solish,
Robert A Weiss
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ABSTRACT: BACKGROUND: Botulinum toxin type A is a proven, effective aesthetic treatment for glabellar frown lines. IncobotulinumtoxinA (NT 201, Xeomin/Xeomeen/Bocouture, Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a 150-kDa botulinum toxin type A free of complexing proteins. OBJECTIVE: To assess the efficacy and safety of incobotulinumtoxinA in a randomized, double-blind, placebo-controlled, Phase III study in patients with moderate to severe glabellar frown lines. MATERIALS AND METHODS: Two hundred seventy-six patients were randomized 2:1 to receive a single injection of 20 U of incobotulinumtoxinA or placebo, respectively. Efficacy was assessed at day 30 using a Food and Drug Administration-mandated composite endpoint; a responder was defined as a patient with a 2-point or greater improvement in glabellar frown lines on a 4-point scale as assessed by investigator and patient. Safety was assessed periodically through Day 120. RESULTS: Treatment with a single dose of incobotulinumtoxinA was significantly superior to placebo in the treatment of glabellar frown lines at Day 30 using the composite endpoint (p < .001), with investigators and patients assessing glabellar frown lines as significantly more improved after incobotulinumtoxinA injection than with placebo (p < .001). IncobotulinumtoxinA was well tolerated. CONCLUSION: A single dose of 20 U of incobotulinumtoxinA demonstrated efficacy and safety in the treatment of glabellar frown lines using new Food and Drug Administration efficacy variables.
Dermatologic Surgery 02/2013; · 1.80 Impact Factor
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Dermatologic Surgery 01/2013; 39(1 Pt 2):149. · 1.80 Impact Factor
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Dermatologic Surgery 09/2012; 38(9):1571-2. · 1.80 Impact Factor
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ABSTRACT: Mid-face reflation requires a sophisticated knowledge of bony and soft tissue anatomy.
To blend knowledge of the relevant anatomy with clinical experience to generate procedural guidelines for reproducible volumization of the midface.
A demonstration of cadaver head dissection was followed by injection of colored hyaluronic acid and calcium hydroxylapatite fillers into cadaver heads in the anatomy laboratory. The injected cadaver heads were then dissected to assess the anatomical position of the injected fillers. Live patient injections followed using the anatomic learning.
Best practice guidelines for midface and infraorbital hollow injections were discussed.
Aesthetic augmentation of the midface requires knowledge of the properties of each filler and of the underlying anatomy, as well as an understanding and documentation of the subject's aesthetic concerns.
Dermatologic Surgery 07/2012; 38(7 Pt 2):1223-33. · 1.80 Impact Factor
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Dermatologic Surgery 03/2012; 38(3):451-3. · 1.80 Impact Factor
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Rhoda S Narins,
Jean Carruthers,
Timothy C Flynn,
Thorin L Geister,
Roman Görtelmeyer,
Bhushan Hardas,
Silvia Himmrich,
Derek Jones,
Martina Kerscher,
Maurício de Maio,
Cornelia Mohrmann,
Rainer Pooth,
Berthold Rzany,
Gerhard Sattler,
Larry Buchner,
Ursula Benter,
Lusine Breitscheidel, Alastair Carruthers
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ABSTRACT: Aging in the lower face leads to lines, wrinkles, depression of the corners of the mouth, and changes in lip volume and lip shape, with increased sagging of the skin of the jawline. Refined, easy-to-use, validated, objective standards assessing the severity of these changes are required in clinical research and practice.
To establish the reliability of eight lower face scales assessing nasolabial folds, marionette lines, upper and lower lip fullness, lip wrinkles (at rest and dynamic), the oral commissure and jawline, aesthetic areas, and the lower face unit.
Four 5-point rating scales were developed to objectively assess upper and lower lip wrinkles, oral commissures, and the jawline. Twelve experts rated identical lower face photographs of 50 subjects in two separate rating cycles using eight 5-point scales. Inter- and intrarater reliability of responses was assessed.
Interrater reliability was substantial or almost perfect for all lower face scales, aesthetic areas, and the lower face unit. Intrarater reliability was high for all scales, areas and the lower face unit.
Our rating scales are reliable tools for valid and reproducible assessment of the aging process in lower face areas.
Dermatologic Surgery 02/2012; 38(2 Spec No.):333-42. · 1.80 Impact Factor
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Timothy C Flynn, Alastair Carruthers,
Jean Carruthers,
Thorin L Geister,
Roman Görtelmeyer,
Bhushan Hardas,
Silvia Himmrich,
Martina Kerscher,
Maurício de Maio,
Cornelia Mohrmann,
Rhoda S Narins,
Rainer Pooth,
Berthold Rzany,
Gerhard Sattler,
Larry Buchner,
Ursula Benter,
Constanze Fey,
Derek Jones
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ABSTRACT: Age-related upper face changes such as wrinkles, lines, volume loss, and anatomic alterations may affect quality of life and psychological well-being. The development of globally accepted tools to assess these changes objectively is an essential contribution to aesthetic research and routine clinical medicine.
To establish the reliability of several upper face scales for clinical research and practice: forehead lines, glabellar lines, crow's feet (at rest and dynamic expression), sex-specific brow positioning, and summary scores of forehead and crow's feet areas and of the entire upper face unit.
Four 5-point photonumerical rating scales were developed to assess glabellar lines and sex-specific brow positioning. Twelve experts rated identical upper face photographs of 50 subjects in two separate rating cycles using all eight scales. Responses of raters were analyzed to assess intra- and interrater reliability.
Interrater reliability was substantial for all upper face scales, aesthetic areas, and the upper face score except for the brow positioning scales. Intrarater reliability was high for all scales and resulting scores.
Except for brow positioning, the upper face rating scales are reliable tools for valid and reproducible assessment of the aging process.
Dermatologic Surgery 02/2012; 38(2 Spec No.):309-19. · 1.80 Impact Factor
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Gerhard Sattler, Alastair Carruthers,
Jean Carruthers,
Timothy C Flynn,
Thorin L Geister,
Roman Görtelmeyer,
Bhushan Hardas,
Silvia Himmrich,
Derek Jones,
Martina Kerscher,
Cornelia Mohrmann,
Rhoda S Narins,
Rainer Pooth,
Berthold Rzany,
Larry Buchner,
Ursula Benter,
Lusine Breitscheidel,
Maurício de Maio
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ABSTRACT: Sagging of the neck aesthetic area is an important indicator of age. The development of complex and globally accepted tools for proper assessment of the change in neck volume is an essential contribution to aesthetic research and the routine clinical setting.
To develop a grading scale for the objective assessment of the neck volume and to establish the reliability of this scale for clinical research and practice.
A 5-point rating scale was developed to assess neck volume objectively. Twelve experts rated frontal and lateral neck photographs of 50 subjects in two separate rating cycles using the neck volume scale. Responses of raters were analyzed to assess inter- and intrarater reliability.
Interrater reliability for the neck volume scale was almost perfect, with intraclass correlation coefficients for the first and second rating cycles of 0.85 and 0.84, respectively. Intrarater reliability for the neck volume scale was high (0.90) and Pearson correlation coefficients ranged between 0.88 and 0.95 and were statistically significant.
The neck volume scale demonstrates optimal reliability for clinical research and practice.
Dermatologic Surgery 02/2012; 38(2 Spec No.):343-50. · 1.80 Impact Factor
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Berthold Rzany, Alastair Carruthers,
Jean Carruthers,
Timothy C Flynn,
Thorin L Geister,
Roman Görtelmeyer,
Bhushan Hardas,
Silvia Himmrich,
Derek Jones,
Maurício de Maio,
Cornelia Mohrmann,
Rhoda S Narins,
Rainer Pooth,
Gerhard Sattler,
Larry Buchner,
Monica Merito,
Constanze Fey,
Martina Kerscher
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ABSTRACT: Twenty grading scales have been developed to assess age-related facial changes. Until now, the validity with regard to the patient's actual age and the clinical importance of combined measurement tools to describe facial aging was unclear.
To investigate the reliability and validity of a total face score and three global face assessment scales for estimated age, estimated aesthetic treatment effort, and signs of aging in the facial units.
Descriptive, reliability, correlation, and principal component analyses based on the assessment of 50 subjects by 12 raters using the 20 grading scales and the global face assessment scales.
Inter- and intrarater reliability was high for the total face score and for the scales on estimated age and aesthetic treatment effort. Actual age was highly correlated with these three measures. Facial aging was indicated particularly by scales of the lower face.
The aesthetic grading scales and global scales on estimated age and aesthetic treatment effort are reliable and valid instruments. The results suggest that a more-comprehensive evaluation of the human face and its age-related changes can help to identify important areas of facial aging and to define optimal aesthetic treatment strategies.
Dermatologic Surgery 02/2012; 38(2 Spec No.):294-308. · 1.80 Impact Factor
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Jean Carruthers,
Timothy C Flynn,
Thorin L Geister,
Roman Görtelmeyer,
Bhushan Hardas,
Silvia Himmrich,
Derek Jones,
Martina Kerscher,
Maurício de Maio,
Cornelia Mohrmann,
Rhoda S Narins,
Rainer Pooth,
Berthold Rzany,
Gerhard Sattler,
Larry Buchner,
Ursula Benter,
Lusine Breitscheidel, Alastair Carruthers
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ABSTRACT: The improvement of aesthetic treatment options for age-related mid face changes, such as volume loss, and the increase in patient expectations necessitates the development of more-complex and globally accepted assessment tools.
To develop three grading scales for objective assessment of the infraorbital hollow and upper and lower cheek fullness and to establish the reliability of these scales for clinical research and practice.
Three 5-point rating scales were developed to assess infraorbital hollow and upper and lower cheek fullness objectively. Twelve experts rated identical mid face photographs of 50 subjects in two separate rating cycles using the mid face scales. Test responses of raters were analyzed to assess intra- and interrater reliability.
Interrater reliability was substantial for the infraorbital hollow, upper cheek fullness, and lower cheek fullness scales. Intrarater reliability was high for all three scales. Both of the cheek fullness scales yielded higher reliabilities when three rather than two views were used to assess the volume changes of the cheek.
The mid face scales are reliable tools for valid and reproducible assessment of age-related mid face changes.
Dermatologic Surgery 02/2012; 38(2 Spec No.):320-32. · 1.80 Impact Factor
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ABSTRACT: Current guidelines from the Centers for Disease Control and Prevention (CDC) regarding the reconstitution and storage of botulinum toxin type A (BT-A) differ from those of the Centers for Medicare and Medicaid Services and current clinical practice. CDC guidelines require single-patient use of BT-A vials. Strict adherence to these guidelines creates waste and a significant financial impediment, and does not confer increased protection from infection, assuming standard safe injection practices are followed.
This study examines current clinical practices and provides expert consensus recommendations regarding the reconstitution and storage of BT-A. A review of the literature on the sterility and efficacy of BT-A stored beyond the recommended time period of 4 hours is also presented.
An Internet-based survey was used to analyze the current practices of physician members of the American Society for Dermatologic Surgery who administer botulinum type A toxins.
After reconstitution, the majority of physicians (68.6%) routinely store BT-A for a period of greater than 1 week and safely use each toxin vial for more than one patient. Not a single case of infection was observed.
This was a single survey with a 32.2% response rate.
A single vial of BT-A can be safely administered to multiple patients, assuming standard safe injection techniques are followed. After reconstitution, Our data suggest that BT-A can be stored beyond the recommended time period of 4 hours.
Journal of the American Academy of Dermatology 11/2011; 67(3):373-8. · 3.99 Impact Factor
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ABSTRACT: Botulinum toxin (BoNT) has been in use since the late 1970s, and over the last 20 years, its use has been extended to new indications in various areas of medicine. During these years of clinical use, some of the initial ideas have changed, and others have remained stable along with increasing experience with and knowledge about BoNTs.
To review the literature and prescribing information on all of the available products and to update the concept of handling toxins (preparations, reconstitution, storage, sterility, and dilution).
A review (not Cochrane type analysis) of the medical literature based on relevant databases (MEDLINE, PubMed, Cochrane Library, specialist textbooks, and manufacturer information) was performed.
Many of the precautions around BoNT use, often recommended by the manufacturers, are described in the clinical literature as too restrictive. The literature suggests that toxins may be sturdier and more-resistant to degradation than previously understood.
Dermatologic Surgery 07/2011; 37(11):1553-65. · 1.80 Impact Factor
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ABSTRACT: Drs. Alastair and Jean Carruthers are consultants to Allergan, Inc., and have been paid to do research by Allergan, Inc.
Dermatologic Surgery 07/2011; 37(7):929-30. · 1.80 Impact Factor
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C William Hanke,
Rod J Rohrich,
Mariano Busso, Alastair Carruthers,
Jean Carruthers,
Steven Fagien,
Rebecca Fitzgerald,
Richard Glogau,
Phyllis E Greenberger,
Z Paul Lorenc, [......],
Lisle Poulsen,
Lori Shoaf,
William Seward,
Wendy Smith Begolka,
Robert G Stanton,
Katherine J Svedman,
J Regan Thomas,
Jonathan M Sykes,
Carol Wargo,
Robert A Weiss
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ABSTRACT: The American Academy of Dermatology and the American Society of Plastic Surgeons, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Academy of Dermatology and the American Society of Plastic Surgeons established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report summarizes the deliberations and key points made by the panel and presenters to the panel, and includes a summary of the panel's near-term and longer term recommendations for next steps to help guide future efforts to address the safety, efficacy, and effectiveness of facial soft-tissue fillers. This report represents the panel's assessment of the medical knowledge available on facial soft-tissue fillers at the time of the conference.
Journal of the American Academy of Dermatology 04/2011; 64(4 Suppl):S53-65. · 3.99 Impact Factor
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C William Hanke,
Rod J Rohrich,
Mariano Busso, Alastair Carruthers,
Jean Carruthers,
Steven Fagien,
Rebecca Fitzgerald,
Richard Glogau,
Phyllis E Greenberger,
Z Paul Lorenc, [......],
Lisle Poulsen,
Lori Shoaf,
William Seward,
Wendy Smith Begolka,
Robert G Stanton,
Katherine J Svedman,
J Regan Thomas,
Jonathan M Sykes,
Carol Wargo,
Robert A Weiss
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ABSTRACT: The American Academy of Dermatology and the American Society of Plastic Surgeons, with the support of other sister societies, conducted the Facial Soft-Tissue Fillers: Assessing the State of the Science conference in December of 2009. The American Academy of Dermatology and the American Society of Plastic Surgeons established a panel of leading experts in the field of soft-tissue fillers-from researchers to clinicians-and other stakeholders for the conference to examine and discuss issues of patient safety, efficacy, and effectiveness in relation to the approved and off-label use of soft-tissue fillers, and other factors, including the training and level of experience of individuals administering fillers. This report represents the systematic literature review that examines comprehensively the available evidence and gaps in the evidence related to soft-tissue fillers, to inform and support the work of the state-of-the-science conference panel. This evidence-based medicine review will serve as the foundation for future evidence-based medicine reports in this growing field.
Journal of the American Academy of Dermatology 04/2011; 64(4 Suppl):S66-85, S85.e1-136. · 3.99 Impact Factor
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ABSTRACT: Use of botulinum toxin for esthetic purposes has rapidly expanded over the last 20 years. IncobotulinumtoxinA, also known as NT 201, is a new botulinum toxin type A (150 kDa) that is free from complexing proteins.
A prospective, multicenter, randomized, rater- and patient-blind, international Phase III trial to investigate the noninferiority of incobotulinumtoxinA to another botulinum toxin type A, onabotulinumtoxinA, in the treatment of glabellar frown lines.
A total of 381 patients were randomized in a 3:1 (incobotulinumtoxinA:onabotulinumtoxinA) ratio to receive 24 U incobotulinumtoxinA of or onabotulinumtoxinA. Efficacy end points included the percentage of responders (patients with an improvement of ≥1 point on a 4-point facial wrinkle scale) at maximum frown at weeks 4 and 12 as assessed by the investigators, and a panel of independent raters based on standardized digital photographs.
Four weeks after injection, response rates at maximum frown were 96.4% in the incobotulinumtoxinA group and 95.7% in the onabotulinumtoxinA group as assessed by independent raters. Analysis of the data confirmed the noninferiority of incobotulinumtoxinA. Response rates at rest were lower for both products. The rate of adverse events was low.
IncobotulinumtoxinA is equally as effective as onabotulinumtoxinA in the treatment of glabellar frown lines. Both preparations were well tolerated.
Dermatologic Surgery 12/2010; 36 Suppl 4:2146-54. · 1.80 Impact Factor
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ABSTRACT: Since its initial approval by the US Food and Drug Administration (FDA) 20 years ago for the treatment of strabismus, hemifacial spasm, and blepharospasm in adults, botulinum toxin (BTX) has become one of the most frequently requested products in cosmetic rejuvenation around the world. After years of clinical success and consistent safety in the upper face, the use of BTX has expanded and evolved to include increasingly complicated indications. In the hands of adept injectors, the focus has shifted from the treatment of individual dynamic rhytides to shaping, contouring, and sculpting, alone or in combination with other cosmetic procedures, to enhance the aesthetic appearance of the face. Although recent reports have questioned the safety of BTX, 25 years of therapeutic and over 20 years of cosmetic use has demonstrated an impressive record of safety and efficacy when used appropriately by experienced injectors.
Obstetrics and Gynecology Clinics of North America 12/2010; 37(4):571-82, ix. · 1.70 Impact Factor
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ABSTRACT: Combination treatment with toxins and fillers is the standard regimen in facial rejuvenation. Systematic studies of botulinum toxin alone and in combination with hyaluronic acid (HA) have not, however, been conducted in the lower face.
To evaluate safety and effectiveness and compare combination treatment with onabotulinumtoxinA and a 24-mg/mL smooth, cohesive HA gel filler with either treatment alone for rejuvenation of the perioral area and lower face in female subjects.
Ninety female participants aged 35 to 55 were randomized to one of three groups: 24-mg/mL cohesive gel alone (n=30), onabotulinumtoxinA alone (n=30), or the combination (n=30). Effectiveness outcomes included perioral, lip fullness, and oral commissure assessments and scores on the Cosmetic Improvement and Global Aesthetic Improvement Scales. Adverse events were monitored throughout.
For all end points and most time points, subjects treated with onabotulinumtoxinA plus the 24-mg/mL cohesive gel had greater improvement from baseline than subjects treated with onabotulinumtoxinA or the 24-mg/mL cohesive gel filler alone.
Based on a range of end points, onabotulinumtoxinA and 24-mg/mL cohesive HA gel treatments are effective and safe when either alone or in combination to rejuvenate the lower face. Combination therapy is superior to either modality used alone.
Dermatologic Surgery 12/2010; 36 Suppl 4:2121-34. · 1.80 Impact Factor
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ABSTRACT: OnabotulinumtoxinA is an established treatment for glabellar frown lines, but its effects on lines at repose are less well documented.
To assess the effect of onabotulinumtoxinA on elimination of mild lines at repose.
Data from two randomized, double-blind, placebo-controlled studies were included. Elimination of mild lines at repose was defined as change from mild to none on the Facial Wrinkle Scale.
Analysis included 183 participants who received 20 U of onabotulinumtoxinA and 64 participants who received placebo, all with mild lines at repose at baseline. Participants were evaluated 7, 30, 60, 90, and 120 days posttreatment. Compared to placebo, onabotulinumtoxinA-treated participants were significantly more likely to have their lines at repose eliminated at each study day; [odds ratios ranged from 42.7 (95% confidence interval (CI)=12.9-141.9) at day 30 to 4.9 (95% CI=2.2-10.8) at day 120 (p<.0001 at each day)]. The highest response rate was observed at day 30 (68%).
OnabotulinumtoxinA has demonstrated the ability to eliminate mild glabellar lines at repose for a significant number of patients. This effect, albeit more subtle than the effect on dynamic or more severe glabellar lines, may be an important treatment goal for patients who seek a smoother appearance at repose.
Dermatologic Surgery 12/2010; 36 Suppl 4:2168-71. · 1.80 Impact Factor
