9/25/2018
`AczoneFails to Impress for Rosacea * Rosacea Support Group
` http://rosacea-support.org:80/aczone-fails-to-impress-for-rosacea. html
`418 captures
`1 Aug 2012-3 Jan 2015
`
`JUL AUG SEP
`< 01 >
`2011 2012 2013
`
`ROSACEA SUPPORT GROUP
`
`@® @® 2
`Ei |
`this
`captu
`
`e home
`
`« questions & answers
`«
`forum
`*
`resources
`« australia
`+ FAQ
`co
`book reviews
`advertise here
`about
`blog
`search
`
`d
`od
`°
`
`°c
`
`<— Usinga Hair Dryer to Pre-Flush before Pulse Dye Laser Treatment
`
`More Demodex Dreaming: Mites are the Chicken? —
`
`Aczone Fails to Impress for Rosacea
`
`July 23rd, 2012, by David Pascoe | aczone,allergan, clinical trials
`
`MOOOSSEE
`ACZO NE
`(sre
`Gel, 5%
`“Wrastel las
`
`=a— 4.) We don’t often get to see the actual results from clinical trials. Companies are happy to receive publicity for their
`= A dgx11| research and development programs, especially ifa new product looks promising.Ifthings don’t go we during
`a clinicaltrials, though, it seems that we just never hear about that product again.
`Allergan, the makes of Aczone are unusualin this regard.
`
`30
`
`In 2006 welearnt that Aczone (Topical 5% Dapsone), an approved acne treatment wouldbe trialled as a treatment
`9 forrosacea.
`
`Thetrial, NCT00249782 a multiple arm Phase II trial, would compare Aczone once and twice a day, to the inactive
`gel vehicle, Metrogel 1% on its own and Aczone in the morning in combination with Metrogel in the evening.
`
`All things going well this sort comparison would be able to position Aczoneas a viable adjunct to, or indeed a more effect alternative to the market
`leading Metrogel.
`
`How Did It Go?
`
`Allergan haveasite dedicated to promotingtheir clinical trials — www.allerganclinicaltrials.com . The site also has a section wheretrial results are
`disclosed.
`
`Thetrial of Aczone as a rosacea treatment can only be described as disappointing.
`
`What Did the Trial Discover?
`
`Some highlights from AZC ROS 01, “A Phase II, Randomized, Partial-Blind, Parallel-Group, Active- and Vehicle-Controlled, Multicenter Study of the
`Safety and Efficacy ofAczoneTM (dapsone) Gel, 5% in Subjects with Papulopustular Rosacea”.
`
`« Aczone twice a day wasbetter than Aczone once a day
`« Aczone twice a day wasnotsignificantly better than the vehicle gel twice a day
`e Combining Aczone and Metrogel 1% wasnotsignificantly better than Metrogel 1% on its own.
`e None of any combination of the treatments was able to make a significant dent in erythemaor telangiectasia.
`
`Takeaway Points
`
`Notch this up as another data point. Rosacea treatments are hard. Even established acne treatments are no shoe-in to treat the papules and pustules of
`rosacea. Failures are going to be more commonthan successes.
`
`Further, bettering the existing established treaments of topical metronidazole, topical azelaic acid, systemic antibiotics is an extra hill to climb for
`emerging treatments.
`
`https://web.archive.org/web/201 20801 225046/http:/rosacea-support.org:80/aczone-fails-to-impress-for-rosacea.html
`
`1/6
`
`1 of 6
`
`Almirall EXHIBIT 2010
`
`Amneal v. Almirall
`IPR2018-00608
`
`
`AczoneFails to Impress for Rosacea * Rosacea Support Group
` http://rosacea-support.org:80/aczone-fails-to-impress-for-rosacea. html
`418 captures
`1 Aug 2012-3 Jan 2015
`
`JUL AUG SEP
`< 01 >
`2011 2012 2013
`
`ROSACEA SUPPORT GROUP
`
`@® @® 2
`Ei |
`this
`captu
`
`e home
`
`« questions & answers
`«
`forum
`*
`resources
`« australia
`+ FAQ
`co
`book reviews
`advertise here
`about
`blog
`search
`
`d
`od
`°
`
`°c
`
`<— Usinga Hair Dryer to Pre-Flush before Pulse Dye Laser Treatment
`
`More Demodex Dreaming: Mites are the Chicken? —
`
`Aczone Fails to Impress for Rosacea
`
`July 23rd, 2012, by David Pascoe | aczone,allergan, clinical trials
`
`MOOOSSEE
`ACZO NE
`(sre
`Gel, 5%
`“Wrastel las
`
`=a— 4.) We don’t often get to see the actual results from clinical trials. Companies are happy to receive publicity for their
`= A dgx11| research and development programs, especially ifa new product looks promising.Ifthings don’t go we during
`a clinicaltrials, though, it seems that we just never hear about that product again.
`Allergan, the makes of Aczone are unusualin this regard.
`
`30
`
`In 2006 welearnt that Aczone (Topical 5% Dapsone), an approved acne treatment wouldbe trialled as a treatment
`9 forrosacea.
`
`Thetrial, NCT00249782 a multiple arm Phase II trial, would compare Aczone once and twice a day, to the inactive
`gel vehicle, Metrogel 1% on its own and Aczone in the morning in combination with Metrogel in the evening.
`
`All things going well this sort comparison would be able to position Aczoneas a viable adjunct to, or indeed a more effect alternative to the market
`leading Metrogel.
`
`How Did It Go?
`
`Allergan haveasite dedicated to promotingtheir clinical trials — www.allerganclinicaltrials.com . The site also has a section wheretrial results are
`disclosed.
`
`Thetrial of Aczone as a rosacea treatment can only be described as disappointing.
`
`What Did the Trial Discover?
`
`Some highlights from AZC ROS 01, “A Phase II, Randomized, Partial-Blind, Parallel-Group, Active- and Vehicle-Controlled, Multicenter Study of the
`Safety and Efficacy ofAczoneTM (dapsone) Gel, 5% in Subjects with Papulopustular Rosacea”.
`
`« Aczone twice a day wasbetter than Aczone once a day
`« Aczone twice a day wasnotsignificantly better than the vehicle gel twice a day
`e Combining Aczone and Metrogel 1% wasnotsignificantly better than Metrogel 1% on its own.
`e None of any combination of the treatments was able to make a significant dent in erythemaor telangiectasia.
`
`Takeaway Points
`
`Notch this up as another data point. Rosacea treatments are hard. Even established acne treatments are no shoe-in to treat the papules and pustules of
`rosacea. Failures are going to be more commonthan successes.
`
`Further, bettering the existing established treaments of topical metronidazole, topical azelaic acid, systemic antibiotics is an extra hill to climb for
`emerging treatments.
`
`https://web.archive.org/web/201 20801 225046/http:/rosacea-support.org:80/aczone-fails-to-impress-for-rosacea.html
`
`1/6
`
`1 of 6
`
`Almirall EXHIBIT 2010
`
`Amneal v. Almirall
`IPR2018-00608
`
`
`
`9/25/2018
`AczoneFails to Impress for Rosacea * Rosacea Support Group
` http://rosacea-support.org:80/aczone-fails-to-impress-for-rosacea. html
`JUL AUG SEP
`@®
`01 >
`18 captures
`2011 2012 2013
`1 Aug 2012-3 Jan 2015
`For rosacea sufferers are considered, the most promising would be the Oxymetazoline based topical that they call AGN-199201. This was formerly
`known as V-101 when it was being development by Vicept Therapeutics.
`
`Related Articles
`
`EDAgets tough with Allergan over Aczone
`aczone (topical dapsone) recruiting trial participants
`Allergan buys Aczone, has plansfor rosacea targeting?
`
`Allergan DevelopingOxymetazoline (AGN-199201/V-101) Cream Formulations
`
`Dinit
`
`Read more about: aczone, allergan, clinical trials
`
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`https://web.archive.org/web/201 20801 225046/http:/rosacea-support.org:80/aczone-fails-to-impress-for-rosacea.html
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`AczoneFails to Impress for Rosacea * Rosacea Support Group
`JUL AUG SEP
` http://rosacea-support.org:80/aczone-fails-to-impress-for-rosacea. html
`18 captures
`1 Aug 2012-3 Jan 2015
`
`@
`
`01 >
`2011 2012 2013
`
`- Recent Articles
`
`Metronidazole Gel 2% Good for Acne
`
`Just Diagnosed: JAMA Rosacea Patient Page
`Ocular Rosacea Diagnostic Test One Step Closer
`More Demodex Dreaming: Mites are the Chicken?
`AczoneFails to Impress for Rosacea
`Using a Hair Dryer to Pre-Flush before Pulse Dye Laser Treatment
`Novartis Must DropFougera’s Generic Metrogel
`Does Finacea improve ND: YAG Laser Treatments?
`Combine Brimonidine and Oxymetazoline, Why Not?
`reating Rosacea with Collagen(Matricol)
`
`oO
`Oo
`
`°°°°°°°O
`
`o
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`ooo0o00
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`My Treatments: Rozex,Doryx, ZincO
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`Rosacea Cure eBooks: All Just SPAM?
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`Finacea
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`Metronidazole (metrogel)
`Low Dose Accutane
`How to cure a red face
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`JUL AUG SEP
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`2011 2012 2013 1 Aug 2012-3 Jan 2015
`¢ Eucerin Redness Relief
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