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`Doxycycline hyclate reduces comedones by 50 percent
`Kapes, Beth A.
`,
`Dermatology Times, suppl. Bringing Acne Treatment to the Forefront 22 (Nov
`2001): 519.
`
`Find a copy
`
`~Link Check for full textvia OCLC Unk Resolver
`http://setonhall.on.worldcat.org/atoztitles/link?
`sid=ProQ:&issn=01966197&volume=22&1ssue=&title=Dermatology+Times&spage=S19&date=2001-11-
`0l&atitle=Doxycycline+hyclate+reduces+comedones+by+50+percent&au=Kapes%2C+Beth+A&Id=doi:
`
`Abstract (summary)
`
`Dentists who regularly prescribe a 20-mg dose of Perlostat for its antHnflammatory role agalnst periodontal
`dlsease reported their theory that doxycycllne hyclate may also be effective agalnst adult acne. With thls
`hypothesis, the drug's manufacturer CollaGenex Pharmaceutlcals, embarked on the placebo-controlled, double-
`bllnded, slxmonth, 50 patient cllnical trial to evaluate Doxycycllne's efficacy in treatlng moderate acne.
`
`Full Text
`Newtown, Pa. - The subtherapeutic dosage of doxycycllne hyclate tablets (Dermostat), 20 mg, ls a valuable
`therapy against moderate acne whlle malntainlng a somewhat Independent stature from its antlmicrobial
`affects, according to a multlcenter clinical trlal.
`
`Doxycycline hyclate did reveal statlstically significant benefits agalnst each of the preestablished prlmary
`endpolnts, lncludlng reduclng totallnflammatory lesions and totallesion counts. Most surprlslngly, doxycyllne
`hyclate appears to reduce the total number of comedones by 50 percent, the study's chair, Robert Skldmore,
`M.D., chlef of dermatology, Unlversity of Florlda Medlcal Center, sald.
`
`Dentlsts who regularly prescribe a 20-mg dose of Perlostat for its anti-lnflammatory role agalnst perlodontal
`dlsease reported thefr theory that doxycyclfne hyclate may also be effectfve against adult acne. Wfth thls
`hypothesis, the drug's manufacturer CollaGenex Pharmaceuticals, embarked on the placebo-controlled, double-
`bllnded, slxmonth, 50 patlent clinfcal trial to evaluate Doxycyclfne's efflcacy in treating moderate acne. Rodney
`Kovach, M.D., chief of dermatology, West Virginia Unfversfty Health Seiences Center, also conducted the study.
`
`"While I was inltially skeptlcal ofthe drug effectively addresslng each of the endpolnts- especially the antlcipated
`goal of reducing overail comedones - we dld find this pllot study to show Dermostat's effectiveness an all Ieveis,"
`Dr. Skldmore sald. "There were very few slde effects, in additlon to showing an absence of photosensitivity a slde
`effect seen in many acne theraples."
`
`http://search.proquest.com .ezproxy.shu.edu/printviewfile?accountid= 13793
`
`Dr. Reddy's Laboratories, Ud., et al.
`V.
`Galderma Laboratories, lnc.
`lPR2015-__
`Exhibit 1015
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`1/3
`
`Exh. 1015
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`7/16/2015
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`Dr. Skidmore said the study clearly illustrates the potential clinical benefit of Dermostat in the management of
`inflammatory acne, while showing no bacterial resistance in its submicrobial dosage.
`
`The most compelling evidence that the long-term, low-dose therapy may be beneficial for the treatment of acne
`was presented in the data analysis confirming no evidence of an antimicrobial effect, changes in resistance
`profiles on the skin flora, or cross-resistance to other antibiotics when compared with placebo.
`
`While discussions with the FDA for approval of doxycycline hyclate tablets as Dermostat are planned for this fall,
`and patent applications have been filed with the U.S. Patent and Trademark Office, Dr. Skidmore contended that
`patients with moderate acne could gain benefit from the drug now.
`
`"Periostat was approved by the FDA in 1998, and it could currently be used for its antHnflammatory benefits
`with excellent results," Dr. Skidmore said. "Dermatologists should see from this study that Dermostat appears to
`be a relatively innocuous therapy that can be administered long-term with potentially few side effects." DT
`
`Auth orAffi liation
`By Beth A. Kapes
`
`Staff Correspondent
`
`Copyright Advanstar Communications, Inc. Nov 2001
`
`Indexing ( details)
`
`Subject
`
`Title
`
`Clinical trials;
`Pharmaceuticals;
`Acne;
`Derm atology
`Doxycycline hyclate reduces comedones by 50
`percent
`Kapes, Beth A
`Dermatology Tim es
`22
`Bringing Acne Treatment to the Forefront
`519
`1
`2001
`Nov 2001
`Advanstar Communications, Inc.
`North Olmsted
`United States
`
`Author
`Pu blication title
`Volume
`Supplement
`Pages
`Number of pages
`Publication year
`Pu blication date
`Publisher
`Place of publication
`Country of
`pu blication
`Medical Sciences--Dermatology And Venereology
`Publication subject
`ISSN
`01966197
`CODEN
`DETIEG
`Source type
`Trade Journals
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`Language of
`pu blication
`Document type
`ProQuest document
`ID
`Document URL
`
`Copyright
`
`Last u pdated
`Database
`
`English
`
`Feature
`231159471
`
`http:/ /search .proquest.com/docview/2311594
`71 ?accountid= 13793
`Copyright Advanstar Communications, Inc.
`Nov 2001
`2013-12-04
`ProQuest Central
`
`Copyright© 2015 ProQuest LLC. All rights reserved. Termsand Conditions
`
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`Exh. 1015

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