COSMETIC DERMATOLOGY: PRINCIPLES AND PRACTICE in .NET framework

Create QR Code ISO/IEC18004 in .NET framework COSMETIC DERMATOLOGY: PRINCIPLES AND PRACTICE

COSMETIC DERMATOLOGY: PRINCIPLES AND PRACTICE
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Reloxin/Dysport
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Dysport is sold in bottles containing 500 U of BTX-A Dysport will be marketed in the United States as Reloxin Medicis Pharmaceutical Corporation, which will manufacture and distribute Reloxin in the United States, was awaiting FDA approval for this product at the time of publication Because Reloxin is simply the American brand name for Dysport, which is produced in the United Kingdom, the terms are interchangeable Reloxin will be the term used for the remainder of this portion of the discussion Similar to Botox, the neurotoxin is produced from C botulinum One unit of Botox is equivalent to 25 to 4 U of Reloxin14,15 The units and dilution must be adjusted accordingly Reloxin is manufactured as freeze-dried 500-U vials and preserved as a powder One bottle of Botox contains 5 ng of protein while a vial of Reloxin contains 435 ng16 DILUTION AND STORAGE The shelf life of the packaged Reloxin vial is approximately 1 year, if refrigerated at 2 to 8 C17 The vial should be used within 24 hours of reconstitution, for the
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CLINICAL INDICATIONS
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In the 1970s, Dr Alan Scott became the first scientist to use BTX to treat strabismus in monkeys Within 7 years, he had performed the first human trials4 Subsequently, ophthalmologists began using BTX to treat strabismus, nystagmus, and blepharospasm5,6 In 1990, the first paper reporting the use of BTX for cosmetic purposes was published7 Since that time, the use of BTX has become increasingly widespread and is currently the most popular nonsurgical cosmetic procedure, with 278 million injections performed in 20078 The use of Botox Cosmetic in the United States grew by 41592% from 1997 to 2007 despite the fact that the FDA had yet to approve of its use for cosmetic purposes until halfway through this period!7,8 The cosmetic indications for BTX currently include the prevention and treatment of dynamic wrinkles (wrinkles in motion ) and amelioration of excessive sweating (hyperhidrosis) BTX is also used to ameliorate platysmal banding in
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same reasons that this is recommended with Botox Reloxin can be diluted with 09% preservative-free or preservative-containing saline as suggested in Table 22-3 Using a dilution with 25 mL provides 20 U of Reloxin per 01 mL Reconstituted Reloxin should not be frozen A series of separate studies on glabellar lines were carried out at major cosmetic centers across the United States in order to assess the efficacy, tolerability, and safety of Reloxin prior to FDA approval In two parallel groups of placebo-controlled double-blinded studies including 300 and 158 patients, respectively, subjects were randomized to either Reloxin (50 U) or placebo The study durations were respectively 150 and 180 days Based on visual response scales assessed by investigators and patients, both studies concluded that at 30 days postinjection, Reloxin significantly reached studydesigned improvement endpoints in 90% of patients and reduced the severity of glabellar lines significantly better than placebo (p 0001) The median time of onset was either 2 or 3 days for both studies The median duration of effect was 85 days, with significant efficacy through day 12018 A larger multicenter open-label study was carried out in 21 centers across the United States and enrolled 1200 patients over a 13-month duration Reloxin (50 U) was used for glabellar lines to assess effectiveness and duration Results suggested an onset of action within 3 days and a median duration of 88 days for effect In all series, Reloxin was deemed safe with negligible adverse effects19 Reloxin performs similarly to Botox and is injected in the same sites and manner as Botox It is important to remember that the dose of Reloxin is different than the dose of Botox; otherwise, these are virtually identical products XEOMIN Xeomin (Merz Pharmaceuticals, Frankfurt, Germany) is also a BTX-A prod
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uct containing only the 150 kDa neurotoxin component The smaller size of this compound may increase its diffusion rates; however, this has not been clearly established Xeomin was introduced in Germany in 2005 and is not currently available in other European countries or the United States It is manufactured as 100-U vials Merz Pharmaceuticals claims that the product is highly purified and contains only 600 pg of bacterial proteins,20 which may result in lower immune response In addition, Xeomin differs from Botox and Reloxin in one of its constituent elements While Botox and Reloxin contain sodium chloride and lactose, respectively, Xeomin contains saccharose The clinical conversion rate of Botox to Xeomin is reported as 1:121 A number of major studies conducted and reported by Jost et al demonstrated equal efficacy and safety profiles of Xeomin in the treatment of focal dystonias as compared to Botox The five clinical trials involved 862 patients and found no difference between the two BTX-A toxins in terms of onset of action, duration, or waning of effect22 Further research is needed to evaluate efficacy in cosmetic dermatology and antigenic response of this product NEURONOX Neuronox is a BTX-A complex manufactured by Medy-Tox, Inc (Seoul, South Korea) Neuronox was introduced in South Korea and is currently available in Asia, the Middle East, and Africa It is manufactured as 100-U vials of neurotoxin along with 05 mg of human serum albumin and 09 mg of sodium chloride The conversion rate of Neuronox to Botox is reported to be 1:1 The manufacturers of Neuronox claim that their product is safe and effective; however, efficacy, tolerability, and safety needs to be evaluated by further well-designed research investigations23 PROSIGNE Prosigne (Lanzhou Institute of Biological Products, Lanzhou, China) is a BTX-A product available in China, Southeast Asia, and certain parts of South America The product is manufactured as 50- and 100-U vials There is a lack of evidence regarding the clinical efficacy and safety of Prosigne for the treatment of focal dystonias and hemifacial spasm Evidence is also lacking in terms of ascertaining the precise role of Prosigne in the cosmetic realm To date, only two studies have evaluated this product Tang et al retrospectively studied 785 patients with hemifacial spasm and various types of focal dystonias,
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including blepharospasm to compare Prosigne with Botox They found no significant differences between the two preparations and found an equivalence ratio of 1:15 between Botox and Prosigne24 In the other study, Rieder et al evaluated 28 patients using equivalent units of Botox and Prosigne They demonstrated similar results with both drugs, suggesting a direct bioequivalence Because of the discrepancy between the two studies, which could be due to heterogeneity of patients and methods of sampling, further research is needed in this area to accurately establish the bioequivalence of Prosigne in comparison to other BTX-A preparations25
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