9/25/2018
`
`Aczone Fails to Impress for Rosacea - Rosacea Support Group
`
` http://rosacea-support.org:80/aczone-fails—to-impress-for-rosacea.html
`18 captures
`1Au92012-3Jan 2015
`
`JUL AUG SEP
`4 01 F
`2011 2012 2013
`
`® ® 8
`n a
`1 ,
`,
`
`ROSACEA SUPPORT GROUP
`
`home
`
`5] estions & nswer’s
`forum
`resources
`australia
`mQ
`book reviews
`advertise here
`about
`mg
`sea 0
`
`<— Using, a 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 l acz-one, Mgag, clinical trials
`
`WNW!”
`Aczo NE
`lglflfillmslfi
`E .
`
`)La‘wltgl .215
`
`We don’t often get to see the actual results from clinical trials. Companies are happy to receive publicity for their
`w '11 allflu research and development programs, especially if a new product looks promising. If things don’t go we during
`5"“
`clinical trials, though, it seems that we just never hear about that product again.
`Allergan, the makes ofAczone are unusual in this regard.
`In 2006 we learnt that Aczone (Topical 5% Dapsone), an approved acne treatment would be trialled as a treatment
`9 for rosacea.
`
`30
`
`The trial, 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 Aczone as a viable adjunct to, or indeed a more effect alternative to the market
`leading Metrogel.
`
`HOW Did It Go?
`
`Allergan have a site dedicated to promoting their clinical trials 7 www.allerganclinicaltrialscam . The site also has a section where trial results are
`disclosed.
`
`The trial 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 was better than Aczone once a day
`- Aczone twice a day was not significantly better than the vehicle gel twice a day
`. Combining Aczone and Metrogel 1% was not significantly better than Metrogel 1% on its own.
`. None of any combination of the treatments was able to make a significant dent in erythema or 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 common than 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/20120801225046/http:/rosacea-support.org:80/aczone-faiIs-to-impress-for-rosacea.html
`
`1/6
`
`1 0f 6
`
`Almirall EXHIBIT 2010
`
`Amneal V. Almirall
`IPR2018-00608
`
`
`
`Aczone Fails to Impress for Rosacea - Rosacea Support Group
`
` http://rosacea-support.org:80/aczone-fails—to-impress-for-rosacea.html
`18 captures
`1Au92012-3Jan 2015
`
`JUL AUG SEP
`4 01 F
`2011 2012 2013
`
`® ® 8
`n a
`1 ,
`,
`
`ROSACEA SUPPORT GROUP
`
`home
`
`5] estions & nswer’s
`forum
`resources
`australia
`mQ
`book reviews
`advertise here
`about
`mg
`sea 0
`
`<— Using, a 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 l acz-one, Mgag, clinical trials
`
`WNW!”
`Aczo NE
`lglflfillmslfi
`E .
`
`)La‘wltgl .215
`
`We don’t often get to see the actual results from clinical trials. Companies are happy to receive publicity for their
`w '11 allflu research and development programs, especially if a new product looks promising. If things don’t go we during
`5"“
`clinical trials, though, it seems that we just never hear about that product again.
`Allergan, the makes ofAczone are unusual in this regard.
`In 2006 we learnt that Aczone (Topical 5% Dapsone), an approved acne treatment would be trialled as a treatment
`9 for rosacea.
`
`30
`
`The trial, 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 Aczone as a viable adjunct to, or indeed a more effect alternative to the market
`leading Metrogel.
`
`HOW Did It Go?
`
`Allergan have a site dedicated to promoting their clinical trials 7 www.allerganclinicaltrialscam . The site also has a section where trial results are
`disclosed.
`
`The trial 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 was better than Aczone once a day
`- Aczone twice a day was not significantly better than the vehicle gel twice a day
`. Combining Aczone and Metrogel 1% was not significantly better than Metrogel 1% on its own.
`. None of any combination of the treatments was able to make a significant dent in erythema or 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 common than 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/20120801225046/http:/rosacea-support.org:80/aczone-faiIs-to-impress-for-rosacea.html
`
`1/6
`
`1 0f 6
`
`Almirall EXHIBIT 2010
`
`Amneal V. Almirall
`IPR2018-00608
`
`
`
`9/25/2018
`
`Aczone Fails to Impress for Rosacea - Rosacea Support Group
`
`JUL AUG SEP
`http://rosacea-support.org:80/aczone-fails—to-impress-for-rosacea.html
`
`01 P
`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—l99201. This was formerly
`known as V—lOl when it was being development by Vicept Therapeutics.
`
`Related Articles
`
`FDA gets tough with Allergan over Aczone
`aczone (topical dapsone) recruiting trial participants
`Allergan buys Aczone, has plans for rosacea targmgl
`
`Allergan Developniggiymetazoline (AGN—l99201/V—10 1) Cream Formulations
`
`13w:
`
`Read more about: aczone allergam, clinical trials
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`Aczone Fails to Impress for Rosacea - Rosacea Support Group
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`http://rosacea-support.org:80/aczone-fails—to-impress-for-rosacea.html
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`01 p
`18 captures
`2011 2012 2013
`1 Aug 2012- 3 Jan 2015
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`http://rosacea-support.org:80/aczone-fails—to-impress-for-rosacea.html
`
`01 P
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