Journal of Clinical and Aesthetic Dermatology

MauiDerm Abstract Supplement 2016

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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[ M AY 2 0 1 6 • V O L U M E 9 • N U M B E R 5 ] S U P P L E M E N T T O T H E J O U R N A L O F C L I N I C A L A N D A E S T H E T I C D E R M AT O L O G Y S5 S 5 d apsone could affect the normal microbiome of facial skin where it is usually applied. This study assessed in vitro activity of dapsone versus Gram- positive and Gram-negative bacterial p athogens obtained from patients with infections. Methods: CANWARD is a national surveillance system of antibiotic resistance in Canada. Antimicrobial s usceptibility was assessed using CLSI broth microdilution method. Fifteen centers collected 3,511 isolates from blood, respiratory tract, urine, and wounds. MIC panels were prepared at the Health Sciences Centre in Winnipeg, Canada. Results: Dapsone demonstrated relatively poor activity versus Gram- negative bacilli with most MIC50, MIC90 in the range of 512µg/mL and >512dg/mL, respectively. In contrast, dapsone demonstrated activity versus Gram-positive cocci, such as Staphylococcus, Streptococcus, and Enterococcus: several strains of S. epidermidis had MICs of 32 and 64dg/mL; there were strains of E. faecalis with MICs of 8, 16, 32, and 64dg/mL; and several strains of S. agalactiae and S. pyogenes demonstrated dapsone MICs of 4 to 64dg/mL. Conclusion: Dapsone has demonstrated antimicrobial activity in vitro. Whether this activity is part of the mechanism of action of topical dapsone in acne remains unknown. There are few cutaneous pharmacokinetic data including skin concentration data in the literature about dapsone; however, topical dapsone as a 2% nanoemulsion has shown very high (1196–3837.34dg/cm 2 ) local skin concentrations. At these levels, topical dapsone would be expected to affect the skin flora of patients with acne (especially Gram-positive cocci, such as Staphylococcus and Streptococcus). These concentrations are multiple times higher (20x–1000x) than the dapsone MICs found of many MSSA, MRSA, S. epidermidis, S. agalactiae and S. pyogenes; any of which may be present on the skin of acne patients. Whether this results in resistance to dapsone (i.e., in Gram- p ositive cocci, such as Staphylococcus and Streptococcus) or more importantly results in resistance to chemically unrelated antimicrobials is currently unknown. Evolution of Acne Assessments and Impact on Acne Medications: An Evolving, Imperfect Paradigm Presenters: 1 Linda Stein Gold, MD; 2 J erry Tan, MD; 3 L eon Kircik, MD; 4 Marie-Jose Rueda, MD Affiliations: 1 Department of Dermatology, Henry Ford Hospital, Detroit, MI; 2 University of Western Ontario and Windsor Clinical Research Inc., Ontario, Canada; 3 Indiana University Medical Center, Indianapolis, IN; 4 Galderma Laboratories, L.P., Fort Worth, TX Background: Outcomes for success in acne trials include statistically significant differences from baseline between treatment arms in lesion counts (comedonal, inflammatory, and/or total) and in categorical improvement in investigator global assessments (IGA). However, IGA scales are not standardized and there have been important differences in clinical trial endpoints.. Objectives: We evaluated differences in outcome measures and definition of success in acne trials and their impact on FDA approval and indications for acne medications. Methods: Review of acne clinical trial literature, prescribing information, and regulatory guidelines for currently approved acne medications in the United States. Results: The impression of overall acne severity is subjective and arises from a composite of lesion size/density/type plus lesion distribution and intensity of involvement at affected sites. Numerous IGA scales exist, which are similar on cursory evaluation, but have a number of important variations. Scales vary in number of categories (4–7), inclusion of skin discoloration (erythema present or not), guidance about area of involvement (e.g., half, whole face), or overall quantity of lesions present (rare, some, few, many). One scale defines "clear" as including rare open and closed c omedones. Finally, most scales mix inflammatory and noninflammatory lesions, yet it is very uncommon for these lesions to respond to an acne therapy in the same fashion over the s ame time frame. There are also differences in definitions of global success: Two grade improvement or achievement of clear/almost clear. Outcome success may not be a ccurately translated into corresponding terminology for indications, as most currently approved acne drugs are indicated in the United States "for treatment of acne vulgaris," which at times is independent of efficacy shown on specific lesion types and inclusion severity in clinical trials. Conclusion: Variability in investigator global assessment scales and definitions of success confound comparison of acne trial results. Harmonization and standardization of these factors will facilitate meta- analytics and treatment selection in patient care. Outcome measure success has not consistently been incorporated into acne medication indications. AESTHETICS ATX-101 (Deoxycholic Acid Injection) is Safe and Effective in Men: Results from a Pooled Analysis of the REFINE Trials Presenters: 1,2 Vince Bertucci; 3 Jean Carruthers; 4 Joel Schlessinger; 5 Todd M. Gross; 5 Paul F. Lizzul; 5,6 Frederick C. Beddingfield, III; 5 Christine Somogyi Affiliations: 1 Division of Dermatology, University of Toronto, Toronto, ON, Canada; 2 Bertucci MedSpa, Woodbridge, ON, Canada; 3 Department of Ophthalmology and Visual Sciences, University of British Columbia, Vancouver, BC, Canada; 4 Skin Specialists, P.C., Omaha, NE; 5 Allergan plc, Irvine, CA; 6 David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA Background: ATX-101 (deoxycholic acid injection) is a first- in-class injectable treatment for submental fat (SMF) reduction. Because a strong chin and defined jawline are often associated with authority, self-confidence, and

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