<p>BACKGROUND: The use of blunt-tipped microcannulas for injection of hyaluronic acid (HA) filler... more <p>BACKGROUND: The use of blunt-tipped microcannulas for injection of hyaluronic acid (HA) filler in the lip and perioral area has gained popularity as they provide important safety-related advantages compared to traditional hypodermic needles. This study was conducted to assess the safety and effectiveness associated with the use of a blunt-tipped microcannula for lip augmentation and correction of perioral rhytids using a small-particle, hyaluronic acid gel plus lidocaine (SPHAL).</p> <p>METHODS: A multi-center, open-label, prospective, study enrolled 60 subjects. Subjects reported injection-related events (IREs) for 2 weeks posttreatment via diary. Adverse events (AEs) were collected throughout the study. Secondary assessments at 4 and 12 weeks posttreatment included treating investigator- and subject-reported improvement in lip fullness using the Global Aesthetic Improvement Scale (GAIS) and investigator-assessed improvement in lip fullness using the Medicis Lip Fullness Scale (MLFS).</p> <p>RESULTS: Sixty subjects were enrolled and treated with a mean total volume (ie, both lips and optional perioral rhytids) of 2.2 mL. Treatment-emergent adverse events (TEAEs) reported and assessed as related to the product and/or injection procedure included injection site swelling (13.3%), injection site bruising (6.7%), and injection site pain (1.7%). These were typically mild and transient in nature. No serious AEs (SAEs) were reported. Following treatment, clinically significant improvement using the GAIS and MLFS was demonstrated throughout the study (GAIS improvement at week 12 for both lips: investigator-reported, 98.0%; subject-reported, 84.3%; MLFS improvement at week 12: investigator-reported, 96.1%).</p> <p>CONCLUSION: SPHAL was well tolerated and effective following injection with a blunt-tipped microcannula. No unanticipated safety concerns were identified in the study population.</p> <p><em>J Drugs Dermatol. 2018;17(1):10-16.</em></p>.
BELOTERO BALANCE ® (Injectable hyaluronic acid) BELOTERO BALANCE ® implant package is provided st... more BELOTERO BALANCE ® (Injectable hyaluronic acid) BELOTERO BALANCE ® implant package is provided sterile. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or other licensed healthcare practitioner. Information for the use of BELOTERO BALANCE is provided in this Labeling for Physicians and the Instructions for Use, as well as in Labeling for Patients. BEFORE USING BELOTERO BALANCE, PLEASE READ THE FOLLOWING INFORMATION THOROUGHLY. Please direct any questions to Merz North America, Inc., Franksville, WI 53126 at (866) 862-1211. DESCRIPTION BELOTERO BALANCE is a sterile, bioresorbable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel device. BELOTERO BALANCE is a bacterially fermented, injectable, hyaluronic-acid-based dermal filler. After extraction and purification, hyaluronic acid manufactured from streptococcal cultures is cross-linked with a binding agent 1,4-butanediol diglycidyl ether (BDDE) in two consecutively executed reactions and reconstituted in a physiologic buffer at pH 7 and concentration of 22.5 mg/mL. INTENDED USE/INDICATIONS BELOTERO BALANCE is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. CONTRAINDICATIONS • BELOTERO BALANCE is contraindicated in patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies. • BELOTERO BALANCE contains trace amounts of gram-positive bacterial proteins, and is contraindicated for patients with a history of allergies to such material. • BELOTERO BALANCE must not be implanted into blood vessels. Implantation of BELOTERO BALANCE into dermal vessels may cause vascular occlusion, infarction, or embolic phenomena. WARNINGS • Use of BELOTERO BALANCE at specific sites in which an active inflammatory process (skin eruptions such as cold sores, cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled.
BACKGROUND Filler injection for cosmetic treatment of the aging face may be complicated by visual... more BACKGROUND Filler injection for cosmetic treatment of the aging face may be complicated by visual impairment, skin necrosis, or anaphylaxis because of accidental intravascular injection. Blood aspiration test (withdrawal of blood by the syringe plunger before injection) may decrease the risk of intravascular injection. OBJECTIVE To evaluate the reliability of the aspiration test. METHODS AND MATERIALS A red ink solution was withdrawn from a cup using a syringe containing 0.1 mL filler (17 different filler products); when there was no aspiration, retesting was performed with larger-gauge needles until aspiration was observed. In a white rabbit, aspiration was attempted after puncturing the ear vein and withdrawing the syringe plunger (5 different filler products). RESULTS The aspiration test with an ink solution in vitro was negative with 8 filler products (47%) and positive with 9 filler products (53%); for all products that had a negative aspiration test, the test became positive when a larger-gauge needle was used. All 5 products tested with the rabbit ear aspiration test were positive. CONCLUSION The aspiration test was reliable with 53% syringes and needles tested. Fillers that have a negative aspiration test may be applied when the needle gauge is adjusted.
acial expressions convey emotions and indicate characteristics such as age and quality of life. 1... more acial expressions convey emotions and indicate characteristics such as age and quality of life. 1,2 Facial rejuvenation treatments must Disclosure: Dr. Percec is a paid consultant and speaker for Galderma. Drs. Bertucci and Solish are paid consultants, speakers, and clinical trial investigators for Galderma. Mr. Wagner and Drs. Nogueira and Mashburn are employees of Galderma Laboratories, L.P.
BACKGROUND Hyaluronic acid (HA) dermal fillers are frequently used to correct or smooth facial wr... more BACKGROUND Hyaluronic acid (HA) dermal fillers are frequently used to correct or smooth facial wrinkles and folds such as nasolabial folds. OBJECTIVE To compare the efficacy and safety of 2 HA gels, formulated by 2 different manufacturing processes: XpresHAn Technology (HA RRL [with lidocaine]) and Hylacross technology (HA JU-a comparator product without lidocaine). PATIENTS AND METHODS One hundred seventy subjects with bilateral nasolabial folds rated as moderate or severe, according to the Wrinkle Severity Rating Scale (WSRS), received injections of HA RRL in the nasolabial folds on one side of the face and HA JU on the other side. Investigator-and subject-assessed wrinkle severity was measured up to 48 weeks after final injection. RESULTS HA RRL exhibited a similar safety and efficacy profile compared with HA JU. Noninferiority of HA RRL was demonstrated at 24 weeks (WSRS mean change from baseline mean difference 20.1 [95% confidence interval: 20.15, 0.01], p = .090). Incidence of adverse events was 40% for both treatments. CONCLUSION HA RRL exhibited a similar safety and efficacy profile compared with HA JU. This study was funded by Galderma. G. Monheit, S. Fagien, D. Jones, D. Bank, and N. Sadick are paid consultants and clinical trial investigators for Galderma. A. Nogueira and J.H. Mashburn are employees of Galderma Laboratories, L.P. The authors have indicated no significant interest with commercial supporters.
BACKGROUND Injectable fillers, such as those containing hyaluronic acid (HA), are increasingly us... more BACKGROUND Injectable fillers, such as those containing hyaluronic acid (HA), are increasingly used to smooth age-related facial creases and wrinkles. OBJECTIVE To compare efficacy and safety of a HA gel with lidocaine formulated by XpresHAn Technology (HA RDL) with a HA gel without lidocaine produced by Hylacross technology (HA JUP) in the treatment of moderate-to-severe nasolabial folds. MATERIALS AND METHODS Subjects (n = 162) received initial and touch-up injections with HA RDL and HA JUP on either side of the face. Investigator-and subject-assessed wrinkle severity was measured up to 48 weeks after final injection. RESULTS Mean (SD) Wrinkle Severity Rating Scale was improved by 1.1 (0.75) and 1.1 (0.68) with HA RDL and HA JUP , respectively, at 24 weeks; improvements were sustained up to Week 48 with both treatments. Noninferiority of HA RDL was demonstrated (mean difference 20.09 [95% confidence interval: 20.18 to 20.01], p = .032) at 24 weeks. Adverse events were reported in 43% subjects, 12% were treatment related, with a similar distribution for both treatments. CONCLUSION Effectiveness and safety profiles of HA RDL and HA JUP were comparable. Supported by Galderma. A. Nogueira and J.H. Mashburn are employees of Galderma. Medical writing assistance was provided by H. Shawcross and S. Brown of Fishawack Communications, funded by Galderma. R. Weiss has received support for clinical research and has served as a consultant for Galderma. M. Gold, S. Grekin, and R. Narins have received support from Galderma for clinical research. L. Donofrio has received support for clinical research, served as a consultant, and participated in advisory boards for Galderma. L. Baumann has served as a primary investigator for Galderma.
According to Figure 1.1, Hispanics are also disproportionately affected by the HIV virus (19 perc... more According to Figure 1.1, Hispanics are also disproportionately affected by the HIV virus (19 percent) since Hispanics make up approximately 12 percent of the U.S. population. Overall, the African-American and Hispanic populations are greatly affected by HIV among men and women. HIV/AIDS is the leading cause of death among African-Americans between the ages of 25 to 44 years of age (Kates et al., 2002). It is important to note that Asian/Pacific Islander and American Indian/Alaska Native ethnicities each make up less than one percent of the new HIV infections and AIDS cases in the U.S. Ethnic minorities now represent the majority of new HIV infections and people living with AIDS (Kates et al., 2002). Risk Factors. Figure 1.2 displays AIDS cases by the top four risk factors and gender as reported by the CDC through December 2001.
To perform a longitudinal drug utilization evaluation and to analyse the antibiotic resistance pa... more To perform a longitudinal drug utilization evaluation and to analyse the antibiotic resistance patterns of Pseudomonas aeruginosa as well as the consumption of selected antibiotics. Data from 1992-1997 were collected from the Hospital Pharmacy database at the University Teaching Hospital (1200 beds) where physicians&#39; prescriptions are recorded. To analyse antibiotic consumption, ATC/DDD methodology was used. To express the dynamics of the drug consumption, the value of index I was established. To analyse the resistance patterns of Pseudomonas aeruginosa, data from the antibiotic centre database at The Teaching Hospital were examined. The rate of consumption is on the rise among extend spectrum aminopenicillins, carbapenems, glycopeptides, third generation cephalosporins and second generation macrolides and fluoroquinolones. Antibiotics with a decline in the rate of consumption are first generation macrolides and tetracyclines. The consumption of relatively new and expensive antibiotics increased during the observation period between 1992-1997. Resistance of Pseudomonas aeruginosa to selected antibiotics was identified to be increasing. In the case of amikacin and ceftazidime a possible association between resistance and consumption was found. Copyright (c) 2000 John Wiley &amp; Sons, Ltd.
METHODS: An open-label, non-comparative 12 week prospective study conducted in 4 U.S. centers eva... more METHODS: An open-label, non-comparative 12 week prospective study conducted in 4 U.S. centers evaluated the safety and effectiveness of SPHAL in conjunction with a blunt-tipped cannula. Adverse events (AEs) were collected throughout the study. Subjects reported predefined, expected post-treatment injection site reactions during the first 2 weeks post-treatment via diary. Effectiveness assessments at 4 and 12 weeks post-treatment included treating invesitgatorand subject-reported Global Aesthetic Improvement Sclae (GAIS) scores and treating investigator-reported evaluations using the Medicis Lip Fullness Scale (MLFS).1
acial expressions convey emotions and indicate characteristics such as age and quality of life. 1... more acial expressions convey emotions and indicate characteristics such as age and quality of life. 1,2 Facial rejuvenation treatments must Disclosure: Dr. Percec is a paid consultant and speaker for Galderma. Drs. Bertucci and Solish are paid consultants, speakers, and clinical trial investigators for Galderma. Mr. Wagner and Drs. Nogueira and Mashburn are employees of Galderma Laboratories, L.P.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-... more This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
BELOTERO BALANCE ® (Injectable hyaluronic acid) BELOTERO BALANCE ® implant package is provided st... more BELOTERO BALANCE ® (Injectable hyaluronic acid) BELOTERO BALANCE ® implant package is provided sterile. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or other licensed healthcare practitioner. Information for the use of BELOTERO BALANCE is provided in this Labeling for Physicians and the Instructions for Use, as well as in Labeling for Patients. BEFORE USING BELOTERO BALANCE, PLEASE READ THE FOLLOWING INFORMATION THOROUGHLY. Please direct any questions to Merz North America, Inc., Franksville, WI 53126 at (866) 862-1211. DESCRIPTION BELOTERO BALANCE is a sterile, bioresorbable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel device. BELOTERO BALANCE is a bacterially fermented, injectable, hyaluronic-acid-based dermal filler. After extraction and purification, hyaluronic acid manufactured from streptococcal cultures is cross-linked with a binding agent 1,4-butanediol diglycidyl ether (BDDE) in two consecutively executed reactions and reconstituted in a physiologic buffer at pH 7 and concentration of 22.5 mg/mL. INTENDED USE/INDICATIONS BELOTERO BALANCE is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. CONTRAINDICATIONS • BELOTERO BALANCE is contraindicated in patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies. • BELOTERO BALANCE contains trace amounts of gram-positive bacterial proteins, and is contraindicated for patients with a history of allergies to such material. • BELOTERO BALANCE must not be implanted into blood vessels. Implantation of BELOTERO BALANCE into dermal vessels may cause vascular occlusion, infarction, or embolic phenomena. WARNINGS • Use of BELOTERO BALANCE at specific sites in which an active inflammatory process (skin eruptions such as cold sores, cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled.
Journal of the American Academy of Dermatology, 2018
We define the Chern character of the index class of a G-invariant family of G-transversally ellip... more We define the Chern character of the index class of a G-invariant family of G-transversally elliptic operators, see [6]. Next we study the Berline-Vergne formula for families in the elliptic and transversally elliptic case.
Journal of the American Academy of Dermatology, 2018
Importance: Negative expectations on the part of the patient or the dermatologist can negatively ... more Importance: Negative expectations on the part of the patient or the dermatologist can negatively influence treatment responses resulting in the nocebo effect. Objective: To elucidate the relevance of the nocebo effect in daily dermatologic practice. Evidence review: The search strategy for this review involved searching Medline and SCOPUS for articles published through July 28, 2016, using the key words ''placebo'' or ''nocebo'' and ''cutaneous'' or ''skin.'' Findings: The nocebo effect can impede patient compliance, the healing process, and treatment responses. The biologic bases of both the placebo effect and the nocebo effect are beginning to be elucidated. Some individuals may be genetically more predisposed to the nocebo effect. Conclusions and relevance: How the dermatologist approaches the patient and what language and intonation and body language the dermatologist uses can promote either the placebo effect or the nocebo effect. Examples of key phrases to avoid and to use are included. The first duty of the dermatologist is to do no harm. Commercial support: None identified. 7924 Objective assessment of dry skin roughness in a pediatric population Ga€ etan Boyer,
<p>BACKGROUND: The use of blunt-tipped microcannulas for injection of hyaluronic acid (HA) filler... more <p>BACKGROUND: The use of blunt-tipped microcannulas for injection of hyaluronic acid (HA) filler in the lip and perioral area has gained popularity as they provide important safety-related advantages compared to traditional hypodermic needles. This study was conducted to assess the safety and effectiveness associated with the use of a blunt-tipped microcannula for lip augmentation and correction of perioral rhytids using a small-particle, hyaluronic acid gel plus lidocaine (SPHAL).</p> <p>METHODS: A multi-center, open-label, prospective, study enrolled 60 subjects. Subjects reported injection-related events (IREs) for 2 weeks posttreatment via diary. Adverse events (AEs) were collected throughout the study. Secondary assessments at 4 and 12 weeks posttreatment included treating investigator- and subject-reported improvement in lip fullness using the Global Aesthetic Improvement Scale (GAIS) and investigator-assessed improvement in lip fullness using the Medicis Lip Fullness Scale (MLFS).</p> <p>RESULTS: Sixty subjects were enrolled and treated with a mean total volume (ie, both lips and optional perioral rhytids) of 2.2 mL. Treatment-emergent adverse events (TEAEs) reported and assessed as related to the product and/or injection procedure included injection site swelling (13.3%), injection site bruising (6.7%), and injection site pain (1.7%). These were typically mild and transient in nature. No serious AEs (SAEs) were reported. Following treatment, clinically significant improvement using the GAIS and MLFS was demonstrated throughout the study (GAIS improvement at week 12 for both lips: investigator-reported, 98.0%; subject-reported, 84.3%; MLFS improvement at week 12: investigator-reported, 96.1%).</p> <p>CONCLUSION: SPHAL was well tolerated and effective following injection with a blunt-tipped microcannula. No unanticipated safety concerns were identified in the study population.</p> <p><em>J Drugs Dermatol. 2018;17(1):10-16.</em></p>.
BELOTERO BALANCE ® (Injectable hyaluronic acid) BELOTERO BALANCE ® implant package is provided st... more BELOTERO BALANCE ® (Injectable hyaluronic acid) BELOTERO BALANCE ® implant package is provided sterile. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or other licensed healthcare practitioner. Information for the use of BELOTERO BALANCE is provided in this Labeling for Physicians and the Instructions for Use, as well as in Labeling for Patients. BEFORE USING BELOTERO BALANCE, PLEASE READ THE FOLLOWING INFORMATION THOROUGHLY. Please direct any questions to Merz North America, Inc., Franksville, WI 53126 at (866) 862-1211. DESCRIPTION BELOTERO BALANCE is a sterile, bioresorbable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel device. BELOTERO BALANCE is a bacterially fermented, injectable, hyaluronic-acid-based dermal filler. After extraction and purification, hyaluronic acid manufactured from streptococcal cultures is cross-linked with a binding agent 1,4-butanediol diglycidyl ether (BDDE) in two consecutively executed reactions and reconstituted in a physiologic buffer at pH 7 and concentration of 22.5 mg/mL. INTENDED USE/INDICATIONS BELOTERO BALANCE is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. CONTRAINDICATIONS • BELOTERO BALANCE is contraindicated in patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies. • BELOTERO BALANCE contains trace amounts of gram-positive bacterial proteins, and is contraindicated for patients with a history of allergies to such material. • BELOTERO BALANCE must not be implanted into blood vessels. Implantation of BELOTERO BALANCE into dermal vessels may cause vascular occlusion, infarction, or embolic phenomena. WARNINGS • Use of BELOTERO BALANCE at specific sites in which an active inflammatory process (skin eruptions such as cold sores, cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled.
BACKGROUND Filler injection for cosmetic treatment of the aging face may be complicated by visual... more BACKGROUND Filler injection for cosmetic treatment of the aging face may be complicated by visual impairment, skin necrosis, or anaphylaxis because of accidental intravascular injection. Blood aspiration test (withdrawal of blood by the syringe plunger before injection) may decrease the risk of intravascular injection. OBJECTIVE To evaluate the reliability of the aspiration test. METHODS AND MATERIALS A red ink solution was withdrawn from a cup using a syringe containing 0.1 mL filler (17 different filler products); when there was no aspiration, retesting was performed with larger-gauge needles until aspiration was observed. In a white rabbit, aspiration was attempted after puncturing the ear vein and withdrawing the syringe plunger (5 different filler products). RESULTS The aspiration test with an ink solution in vitro was negative with 8 filler products (47%) and positive with 9 filler products (53%); for all products that had a negative aspiration test, the test became positive when a larger-gauge needle was used. All 5 products tested with the rabbit ear aspiration test were positive. CONCLUSION The aspiration test was reliable with 53% syringes and needles tested. Fillers that have a negative aspiration test may be applied when the needle gauge is adjusted.
acial expressions convey emotions and indicate characteristics such as age and quality of life. 1... more acial expressions convey emotions and indicate characteristics such as age and quality of life. 1,2 Facial rejuvenation treatments must Disclosure: Dr. Percec is a paid consultant and speaker for Galderma. Drs. Bertucci and Solish are paid consultants, speakers, and clinical trial investigators for Galderma. Mr. Wagner and Drs. Nogueira and Mashburn are employees of Galderma Laboratories, L.P.
BACKGROUND Hyaluronic acid (HA) dermal fillers are frequently used to correct or smooth facial wr... more BACKGROUND Hyaluronic acid (HA) dermal fillers are frequently used to correct or smooth facial wrinkles and folds such as nasolabial folds. OBJECTIVE To compare the efficacy and safety of 2 HA gels, formulated by 2 different manufacturing processes: XpresHAn Technology (HA RRL [with lidocaine]) and Hylacross technology (HA JU-a comparator product without lidocaine). PATIENTS AND METHODS One hundred seventy subjects with bilateral nasolabial folds rated as moderate or severe, according to the Wrinkle Severity Rating Scale (WSRS), received injections of HA RRL in the nasolabial folds on one side of the face and HA JU on the other side. Investigator-and subject-assessed wrinkle severity was measured up to 48 weeks after final injection. RESULTS HA RRL exhibited a similar safety and efficacy profile compared with HA JU. Noninferiority of HA RRL was demonstrated at 24 weeks (WSRS mean change from baseline mean difference 20.1 [95% confidence interval: 20.15, 0.01], p = .090). Incidence of adverse events was 40% for both treatments. CONCLUSION HA RRL exhibited a similar safety and efficacy profile compared with HA JU. This study was funded by Galderma. G. Monheit, S. Fagien, D. Jones, D. Bank, and N. Sadick are paid consultants and clinical trial investigators for Galderma. A. Nogueira and J.H. Mashburn are employees of Galderma Laboratories, L.P. The authors have indicated no significant interest with commercial supporters.
BACKGROUND Injectable fillers, such as those containing hyaluronic acid (HA), are increasingly us... more BACKGROUND Injectable fillers, such as those containing hyaluronic acid (HA), are increasingly used to smooth age-related facial creases and wrinkles. OBJECTIVE To compare efficacy and safety of a HA gel with lidocaine formulated by XpresHAn Technology (HA RDL) with a HA gel without lidocaine produced by Hylacross technology (HA JUP) in the treatment of moderate-to-severe nasolabial folds. MATERIALS AND METHODS Subjects (n = 162) received initial and touch-up injections with HA RDL and HA JUP on either side of the face. Investigator-and subject-assessed wrinkle severity was measured up to 48 weeks after final injection. RESULTS Mean (SD) Wrinkle Severity Rating Scale was improved by 1.1 (0.75) and 1.1 (0.68) with HA RDL and HA JUP , respectively, at 24 weeks; improvements were sustained up to Week 48 with both treatments. Noninferiority of HA RDL was demonstrated (mean difference 20.09 [95% confidence interval: 20.18 to 20.01], p = .032) at 24 weeks. Adverse events were reported in 43% subjects, 12% were treatment related, with a similar distribution for both treatments. CONCLUSION Effectiveness and safety profiles of HA RDL and HA JUP were comparable. Supported by Galderma. A. Nogueira and J.H. Mashburn are employees of Galderma. Medical writing assistance was provided by H. Shawcross and S. Brown of Fishawack Communications, funded by Galderma. R. Weiss has received support for clinical research and has served as a consultant for Galderma. M. Gold, S. Grekin, and R. Narins have received support from Galderma for clinical research. L. Donofrio has received support for clinical research, served as a consultant, and participated in advisory boards for Galderma. L. Baumann has served as a primary investigator for Galderma.
According to Figure 1.1, Hispanics are also disproportionately affected by the HIV virus (19 perc... more According to Figure 1.1, Hispanics are also disproportionately affected by the HIV virus (19 percent) since Hispanics make up approximately 12 percent of the U.S. population. Overall, the African-American and Hispanic populations are greatly affected by HIV among men and women. HIV/AIDS is the leading cause of death among African-Americans between the ages of 25 to 44 years of age (Kates et al., 2002). It is important to note that Asian/Pacific Islander and American Indian/Alaska Native ethnicities each make up less than one percent of the new HIV infections and AIDS cases in the U.S. Ethnic minorities now represent the majority of new HIV infections and people living with AIDS (Kates et al., 2002). Risk Factors. Figure 1.2 displays AIDS cases by the top four risk factors and gender as reported by the CDC through December 2001.
To perform a longitudinal drug utilization evaluation and to analyse the antibiotic resistance pa... more To perform a longitudinal drug utilization evaluation and to analyse the antibiotic resistance patterns of Pseudomonas aeruginosa as well as the consumption of selected antibiotics. Data from 1992-1997 were collected from the Hospital Pharmacy database at the University Teaching Hospital (1200 beds) where physicians&#39; prescriptions are recorded. To analyse antibiotic consumption, ATC/DDD methodology was used. To express the dynamics of the drug consumption, the value of index I was established. To analyse the resistance patterns of Pseudomonas aeruginosa, data from the antibiotic centre database at The Teaching Hospital were examined. The rate of consumption is on the rise among extend spectrum aminopenicillins, carbapenems, glycopeptides, third generation cephalosporins and second generation macrolides and fluoroquinolones. Antibiotics with a decline in the rate of consumption are first generation macrolides and tetracyclines. The consumption of relatively new and expensive antibiotics increased during the observation period between 1992-1997. Resistance of Pseudomonas aeruginosa to selected antibiotics was identified to be increasing. In the case of amikacin and ceftazidime a possible association between resistance and consumption was found. Copyright (c) 2000 John Wiley &amp; Sons, Ltd.
METHODS: An open-label, non-comparative 12 week prospective study conducted in 4 U.S. centers eva... more METHODS: An open-label, non-comparative 12 week prospective study conducted in 4 U.S. centers evaluated the safety and effectiveness of SPHAL in conjunction with a blunt-tipped cannula. Adverse events (AEs) were collected throughout the study. Subjects reported predefined, expected post-treatment injection site reactions during the first 2 weeks post-treatment via diary. Effectiveness assessments at 4 and 12 weeks post-treatment included treating invesitgatorand subject-reported Global Aesthetic Improvement Sclae (GAIS) scores and treating investigator-reported evaluations using the Medicis Lip Fullness Scale (MLFS).1
acial expressions convey emotions and indicate characteristics such as age and quality of life. 1... more acial expressions convey emotions and indicate characteristics such as age and quality of life. 1,2 Facial rejuvenation treatments must Disclosure: Dr. Percec is a paid consultant and speaker for Galderma. Drs. Bertucci and Solish are paid consultants, speakers, and clinical trial investigators for Galderma. Mr. Wagner and Drs. Nogueira and Mashburn are employees of Galderma Laboratories, L.P.
This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-... more This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
BELOTERO BALANCE ® (Injectable hyaluronic acid) BELOTERO BALANCE ® implant package is provided st... more BELOTERO BALANCE ® (Injectable hyaluronic acid) BELOTERO BALANCE ® implant package is provided sterile. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or other licensed healthcare practitioner. Information for the use of BELOTERO BALANCE is provided in this Labeling for Physicians and the Instructions for Use, as well as in Labeling for Patients. BEFORE USING BELOTERO BALANCE, PLEASE READ THE FOLLOWING INFORMATION THOROUGHLY. Please direct any questions to Merz North America, Inc., Franksville, WI 53126 at (866) 862-1211. DESCRIPTION BELOTERO BALANCE is a sterile, bioresorbable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel device. BELOTERO BALANCE is a bacterially fermented, injectable, hyaluronic-acid-based dermal filler. After extraction and purification, hyaluronic acid manufactured from streptococcal cultures is cross-linked with a binding agent 1,4-butanediol diglycidyl ether (BDDE) in two consecutively executed reactions and reconstituted in a physiologic buffer at pH 7 and concentration of 22.5 mg/mL. INTENDED USE/INDICATIONS BELOTERO BALANCE is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. CONTRAINDICATIONS • BELOTERO BALANCE is contraindicated in patients with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple severe allergies. • BELOTERO BALANCE contains trace amounts of gram-positive bacterial proteins, and is contraindicated for patients with a history of allergies to such material. • BELOTERO BALANCE must not be implanted into blood vessels. Implantation of BELOTERO BALANCE into dermal vessels may cause vascular occlusion, infarction, or embolic phenomena. WARNINGS • Use of BELOTERO BALANCE at specific sites in which an active inflammatory process (skin eruptions such as cold sores, cysts, pimples, rashes, or hives) or infection is present should be deferred until the underlying process has been controlled.
Journal of the American Academy of Dermatology, 2018
We define the Chern character of the index class of a G-invariant family of G-transversally ellip... more We define the Chern character of the index class of a G-invariant family of G-transversally elliptic operators, see [6]. Next we study the Berline-Vergne formula for families in the elliptic and transversally elliptic case.
Journal of the American Academy of Dermatology, 2018
Importance: Negative expectations on the part of the patient or the dermatologist can negatively ... more Importance: Negative expectations on the part of the patient or the dermatologist can negatively influence treatment responses resulting in the nocebo effect. Objective: To elucidate the relevance of the nocebo effect in daily dermatologic practice. Evidence review: The search strategy for this review involved searching Medline and SCOPUS for articles published through July 28, 2016, using the key words ''placebo'' or ''nocebo'' and ''cutaneous'' or ''skin.'' Findings: The nocebo effect can impede patient compliance, the healing process, and treatment responses. The biologic bases of both the placebo effect and the nocebo effect are beginning to be elucidated. Some individuals may be genetically more predisposed to the nocebo effect. Conclusions and relevance: How the dermatologist approaches the patient and what language and intonation and body language the dermatologist uses can promote either the placebo effect or the nocebo effect. Examples of key phrases to avoid and to use are included. The first duty of the dermatologist is to do no harm. Commercial support: None identified. 7924 Objective assessment of dry skin roughness in a pediatric population Ga€ etan Boyer,
Uploads
Papers by Jay Mashburn