Maui + Derm 2017 March 19 - 24, 2017 Acne Vulgaris & EBDs

17 Pages·2017·1.94 MB·English

3/18/17
Academic Appointments
§ Ass§istaDnte Cplianrictaml Peronfte sosof rMedicine, Division of Dermatology, Nashville, TN USA
§Vanderbilt University School of Medicine: 2006 -2014
§Vanderbilt University School of Nursing: 2006 -Present
§ Adj§uncMt Aeshsiastrarnyt PMroefedssicoarl College: 2013 -Present
Maui + Derm 2017 §School of Medicine, Nashville, TN USA
March 19 -24, 2017 §Visi§tingH Puroafesshsaorn o Hf Doesrpmiattaoll,o Fgyudan University (Shanghai Medical University), Shanghai, China:
2006 -Present
Lasers, Lights, Radiofrequency and More §The First Hospital of China Medical University, Shenyang, China: 2008 -Present
§Guangdong Provincial People’s Hospital, Guangzhou, China: 2013 –Present
Fat and Acne §The People’s Hospital of Hunan Province: 2016 -2019
Presented by Michael H. Gold, MD
Gold Skin Care Center, Tennessee Clinical Research Center Nashville, TN USA §Visi§§tingFT Pihrroestf e FPsisreosort o pAfl ePffl’aisls itHaicto eSsudpr giHetaroyls opfit Faol sohf aZnh eUjniaivnegr Usintyi,v eGurasnigtdyo,n Hg,a Cnhgiznhao: u2,0 Z1h2e -jiParnegs:e 2n0t13 -
Present
Conflict of Interest
§Consultant to many pharmaceutical, cosmeceutical, laser and energy-based device companies
§Consultant, performs research and speaks on behalf of numerous pharmaceutical and medical
device companies
§For the benefit of this presentation: consultant, investigator, speaker for Lumenis, Syneron-
Candela, Aerolase, Advantix, Invasix, Allergan (Kybella), Neothetics, Zeltiq, Zimmer, and Syneron- Acne Vulgaris & EBDs
Candela
Presented by Michael H. Gold, MD
Gold Skin Care Center, Tennessee Clinical Research Center Nashville, TN USA
ALA-PDT for Acne
Acne Vulgaris Expert Review of Dermatology 2006
•Laser/Light technology for the treatment of acne vulgaris
•Work typically for acne via 3 main premises:
•Destruction of the P. acnes bacteria
•Destruction of the entire sebaceous gland and sebaceous output
•? Destroy P. acnesand partial destruction of sebaceous glands --ALA-PDT
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Acne Vulgaris Acne Vulgaris
•Laser/Light technology •Blu-U device FDA cleared for inflammatory acne
•Lasers/light sources to reduce the P. acnespopulation •Used originally for ALA-PDT therapy
•Blue Light Sources -Blu-U (Dusa) •Works for mild to moderate inflammatory acne vulgaris as well
•(InLutemnesen iPs)u,,l sEeldlip Lsigeh (tD DDeDv)i,c eelso–s QPuluasn(Stuynme/rVoans)c, uBlBigLh/tJ/oLuulme (eSnciist oOnn),e, /HMa2rm2 ony •2004 AAD Poster Presentation; J Drugs Dermatol 2004–Gold, Goldman, Rao
XL (Alma), Lumecca (Invasix)
•Blu-U more effective in inflammatory acne lesions than 1% clindamycin
•Vascular Lasers –Cynergy (Cynosure), V-Beam Perfecta (Candela), N-Lyte solution
(ICN), AdvaTX (Advantix)
•Safety and efficacy proved
•Short-Pulsed 650 usec 1064 nm –Aerolase Neo
BLU-U Blue Light Photodynamic Therapy IPL Technology
Illuminator Model 4170
Open BLU-U Closed BLU-U
Presented by Michael H. Gold, MD
Gold Skin Care Center, Tennessee Clinical Research Center Nashville, TN USA
Acne Vulgaris Solta Isolaz
•Laser/Light technology
•Intense Pulsed Light (IPL) technology for acne-many systems
exist
•Quantum, VascuLight, Lumenis One, M22 by Lumenis
•Other systems –Harmony by Alma, BBL by Sciton, Isolaz by
Solta, Elos Plus by Syneron, Lumecca (Invasix)
•ClearTouch, SkinStation by Radiancy
•Ross V (2002 ASLMS) –50% inflammatory acne lesion Presented by Michael H. Gold, MD
improvement Gold Skin Care Center, Tennessee Clinical Research Center Nashville, TN USA
•Elman M, Lebzelter J. Light therapy in the treatment of
acne vulgaris. Dermatol Surg 2004; 30: 130-146.
•85% > 50% improvement; 15-20% non-responders
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Solta -ISOLAZ Photopneumatic Technology:
In Side Out Light Amplified Tx Zone The Mechanism
•Multi-Application Platform
• Acne therapy -iACTherapy
• Skin rejuvenation -iSRTherapy
• Hair removal -iHRTherapy
•Only system to clear the pores from the
dermis outward
•Only system FDA cleared to treat
comedonal & pustular acne
•Proprietary iTM Technology •Hand piece is •Targets elevated •Light applied to •Targets are safely
• Accumulates 3x Energy in Deep Targets placed on closer to skin’s treatment area and painlessly
While Keeping the Epidermis Cool treatment area surface destroyed
• Uesnehsa inMcPe dM dueltei-pP puolsree tcelcehannoslionggy for •reBdlouocde dconcentration
•Melanin concentration
reduced
AdvaTX
Gold MH, Biron J. J Drugs Dermatol 2008; 7(2):139-145
Presented by Michael H. Gold, MD
Gold Skin Care Center, Tennessee Clinical Research Center Nashville, TN USA
ADVATx Dermatological Laser Aerolase Neo
High powered, Long-term Yellow laser
589nm, yellow reductionof –the optimal wavelength
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Easyuseand Pefofticeinetn atnd twerneaeavrtegmlye enlongstt sht h.i naA ntth taehn emy s eoaltamhneeirn t l iaimns eeth,r eth e
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of acne 532 nm.
No consumables Etfsorcfefare arpcststm, iowvereianartstiss, Absorption 532 nm589 nm Gold Skin CParree sCeenntteer,d T ebnyne Msseice hCalineicl aHl R. eGseoalrdch, CMenDter Nashville, TN USA
& wrinkles MHbeOla2nin
350 450 550 650 750
Wavelength(nm)
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LightPod Neo® Acne Vulgaris
The Single Most Versatile Laser in the World. Period.
• 650-microsecond technology for up to 255 J/cm2 in a single pulse
duration •Laser/Light technology
• More than 50 FDA cleared medical aesthetic indications •Lasers to reduce the sebaceous glands themselves
• Ability to perform anesthetic, gel & skin contact free treatment on •810 nm diode laser with indocyanine green (Cynosure)
all skin types
•1450 nm SmoothBeamlaser (Candela-Syneron)
• Eliminates pain, burns or adverse effects of the previous •1320 nm CoolTouch IIIlaser (CoolTouch Corp-Syneron)
generation of lasers
•1319 nm Sciton Profilelaser (Sciton Corp)
• No costly service contracts
Laser Therapy of Acne Vulgaris in Asians
Acne Laser –1450 nm
Photoderm, Photoimmun Photomed 2009;25:3-7
Smoothbeam-Candela
Significant reduction in acne counts –5.43 to 0.43 –destruction of sebaceous glands
Fractora by Invasix for Acne
Presented by Michael H. Gold, MD
Gold Skin Care Center, Tennessee Clinical Research Center Nashville, TN USA
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Fat Reduction Kybella by Allergan
Presented by Michael H. Gold, MD Presented by Michael H. Gold, MD
Gold Skin Care Center, Tennessee Clinical Research Center Nashville, TN USA Gold Skin Care Center, Tennessee Clinical Research Center Nashville, TN USA
Introducing KYBELLA™ (deoxycholic acid) Injection •KYBELLA™ (deoxycholic acid) Injection
KYBELLA™ is the first and only FDA approved injectable
•KYBELLA™ 10mg/mL issupplied in 2mL, single patient drug that contours and improves the appearance of
use vials(4 pack) submental fullness Lysis of adipocytes
•Store at room temperature 20°C to25°C (68°F to 77°F) Wfath ceenl lisn. jOecntceed d inetsotr souybecdu, ttahnoesoeu cse fllast c, aKnYnBoEtL LsAto™r ec aour saecsc tuhme udleatsetr fuacttion of HAdeiapltohcyytes
•Excursions are permitted between 59°F to 86°F
•Each vial is for a single patient use Ttore tahtem peanttie wnitt’hs aKeYsBtEhLeLtAic™ g oisa clsu sfotor maniz iemd pbryo vtheed pchhiyns ician
•Do not dilute or admix KYBELLA™ profile
•Discard unused portion Orentrceea tthmee anets itsh neotitc erxepsepcotnesde is achieved with KYBELLA™, Submental fat
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Please see complete KYBELLA™ (deoxycholic acid) injection Important Safety Informationon slides 58 -60. The safe and effective use of KYBELLA™ for the treatment of
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Lipo 202 by Neothetics LIPO-202:
Potential Best-in-Class Non-Surgical Procedure
•Salmeterol Xinafoate LLIIPPOO--220022
•Long-acting beta-2 adrenergic AAddmmiinniissttrraattiioonn
receptor agonist
•Target Patients Are Not Obese
•Maintain stable weight and lifestyle
•BMI < 30 kg/m2
•Once-Weekly Injections for 8 Weeks
•Measurable results as soon as Week 4
•30-gauge, ½ -Inch Needle
Presented by Michael H. Gold, MD •No numbing agent required •20 injections spaced 4 cm apart
Gold Skin Care Center, Tennessee Clinical Research Center Nashville, TN USA •No recovery or down time •Drug diffuses ~2 cm in radius
•Favorable Safety and Tolerability Profile
•Similar to placebo
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Well Understood, Targeted Mechanism of Action Key Highlights
•Triggers body’s metabolism of stored triglycerides via natural process of lipolysis •Salmeterol Xinafoate (SX) for Injection for non-ablative, localized
•Resulting in reduction in size / volume of fat cells in treatment area LIPO-202 fat reduction and body contouring in central abdominal bulging
LIPO-202 shrinks fat cells without killing them Phase 3 -Ready due to subcutaneous fat in non-obese subjects
•Mimics endogenous process
Known Mechanism•Stimulation of lipolysis via β2-adrenergic receptor
•No fat cell death or apoptosis
•~800 patients in 6 clinical studies
ComDpaetalling •Statistically significant and clinically meaningful reductions
•Safety equivalent to placebo
R5e0g5u(lba)t(o2r)y •Referenceable safety profile of SX as SEREVENT DISKUS®ADVAIR®
Pathway HFA and ADVAIR DISKUS®
•Pivotal Phase 3 studies to be completed in 2015
Phase 3 in 2015 •2 concurrent studies in the U.S. –800 patients each (400 LIPO-
202, 400 Placebo)
The Emerging market for Lipodissolving CoolSculpting System and Applicators
•So this field is changing and changing quickly
•Use only FDA approved products
Cryolipolysis
Semin Cutan Med Surg 32; 31-34: 2013
The next evolution of the world’s #1
non-invasive fat reduction treatment
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Zeltiq CryoLipolysis Zeltiq CryoLipolysis
Lasers Surg Med 2009; 41: 703 –708. Lasers Surg Med 2009; 41: 785 –795.
Long-term efficacy follow-up on two cryolipolysis case studies
Journal of Cosmetic Dermatology, 15, 561-564
CoolMini
Submental and Other Small Area Indications
Presented by Michael H. Gold, MD
Gold Skin Care Center, Tennessee Clinical Research Center Nashville, TN USA
CoolMini Applicator Clinical Studies
•Submental Area
•Designed for submental fat
•IDE Pilot –15 subjects (2013)
•Ideal for smaller bulges •Mexico Feasibility Study –32 Subjects (Q3 2014)
•US Pivotal Study –60 Subjects (Q1/Q2 2015)
•Treat new areas of undesirable fat
•Brian Zelickson –Minneapolis
•Suzanne Kilmer –Sacramento
•Jay Burns -Dallas
•European Pilot Evaluation –150+ Subjects (current)
•Distal Thigh (Above Knee)
•Multi-Centered Study –40 Subjects (current)
•Brian Biesman –Nashville
•Jeffrey Dover/Michael Kaminer –Boston
•Roy Geronemus –New York
•Leyda Bowes -Miami
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Mexico Feasibility Subject 005 MRI Results Methods
•Multi-center study: Drs. Burns, Kilmer, and Zelickson
•Study population: n=60 male and female subjects
•Device: CoolMini small volume vacuum applicator (prototype)
•60 minute cycle at -10°C
•1 treatment cycle per visit
•Up to 2 treatment visits, 6 weeks apart
•Final follow-up 12 weeks after final treatment
Baseline 10 Weeks Post 1 Tx
ConfidFeonrt Iianlt e–rPnraol pUesret yO onfl yZELTIQ 43
Applicator Shapes What’s Next?
•Let’s make a big CoolMini for the flanks and abdomen!
Surface Parallel Plate Cup
•Prototypemachined metal insert modified a standard parallel
plate CoolCore into a cooled, contoured cup applicator
• Special purpose • General purpose • General purpose
• Non-pinchable fat • Medium heat • Fast heat extraction
• Slow heat extraction extraction • Enhanced comfort
• The basis for the new
CoolAdvantage
Applicators
Introducing the CoolAdvantage
Cool Advantage Family Family of Applicators
3–in–1 Design
•Three different contours
Single Applicator Replaces Three Applicators
•CoolCore
•CoolCurve+
•CoolFit
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Introducing the CoolAdvantage Applicator Series It Starts with…Years of Research
Improved Comfort
Greater Comfort
• New cup design
• Lower suction pressure for
gentler tissue draw
•Contoured cup cooling surface
•Shorter treatment times
•Greater comfort
•Better patient experience
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It Starts with…Years of Research It Starts with…Years of Research
Better Patient Experience
Faster Treatment Time
Even distribution of cold
Colder Temperatures
Shorter Time Greater versatility
More tissue is in contact with the cold surface
Almost half the time!
(35 minute treatment time)
Study Objective Methods
•Contoured cup, medium-sized applicator was developed to cool tissue more •Study population: n=19 male and female subjects
efficiently •Randomized left / right flank treatments to compare applicators
•increase tissue contact
•CoolCore applicator vs. CoolAdvantage (prototype)
•reduce vacuum pressure
•CoolCore 60 minutes at -10°C
•reduce treatment time
•CoolAdvantage 35 minutes at -11°C
•Evaluate prototype CoolAdvantage vs. standard CoolCore applicator for safety,
efficacy, and patient preference •1 treatment cycle
•Final follow-up 12 weeks post-treatment
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Z Wave by Zimmer
Equivalent Efficacy, Reduced Pain, Greater Patient Preference
•Equivalent Efficacy: Bilateral flank treatments showed similar
efficacy by
•Ultrasound fat layer reduction measurements
•Independent photo review by 3 blinded physician Beyond Submental Fat
evaluators
•45% reduced procedure discomfort compared to standard
CoolCore
•85% preferred CoolAdvantage in patient surveys
Presented by Michael H. Gold, MD
Gold Skin Care Center, Tennessee Clinical Research Center Nashville, TN USA
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Radial Pulsed Therapy
Zimmer Z-Wave Shock Wave Technology
The Handpiece & Software
Major Use in US: Acceleration of Recuperation, Diminished Pain, UltraShape
Quicker Recovery and Improvement of Fat Reduction and the new UltraShape Power
•Cool Sculpt
•Vanquish
•Liposonix
•Thermi
•Liposuction
Presented by Michael H. Gold, MD
Gold Skin Care Center, Tennessee Clinical Research Center Nashville, TN USA
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