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`Aczone Fails to Impress for Rosacea
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`Written by David Pascoe in Aczone (Dapsone Gel 5%), Allergan, clinical trials with 0 Comments
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`i~1
`ADhrii~TM ~
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`I)~lmi
`
`~BI, 5N
`
`We don’t often get to see the actual results from clinical
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`trials. Companies are happy to receive publicity for their
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`research and development programs, especially if a new
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`product looks promising. If things don’t go we during
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`__~g clinical trials, though, it seems that we just never hear
`about that product again.
`
`Search the site
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`Oustom Search
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`Site Sponsors
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`Allergan, the makes of Aczone are unusual in this regard. ~ "~ -)
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`In 2BO6 we learnt that Aczone (Topical 5% Dapsone), an approved acne treatment would
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`be trialled as a treatment for rosacea.
`
`--t~ ~1~ ~j
`¯
`~w~l~ ~iiJ~
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`The trial, NCTBB249782 a multiple arm Phase II trial, would compare Aczone once and
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`twice a day, to the inactive gel vehicle, M etrogel 1% on its own a nd Aczone in the morning
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`in combination with Metrogel in the evening.
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`All things going well this sort comparison would be able to position Aczone as a viable
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`adjunct to, or indeed a more effect alternative to the market leading Metrogel.
`
`~,
`
`:
`
`How Did It GO?
`
`"OR SENSITIVE SK ~,
`
`.~ ~.~o~°~o~.~ 0
`
`~,~
`
`~-~’Pa -Oil
`
`Allergan have a site dedicated to promoting their clinical trials -
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`www.allerganclinicaltrials.com. The site also has a section where trial results are
`
`,,i~
`=~::
`
`orOer
`
`Q ~er~f
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`disclosed.
`
`The trial of Aczone as a rosacea treatment can only be described as disappointing.
`
`What Did the Trial Discover?
`
`Please Like Us
`
`Some highlights from AZC ROS 01, "A Phase II, Randomized, Partial-Blind, Parallel-Group,
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`~ ~llW, I~
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`Active- and Vehicle-Controlled, M ulticenter Study of the Safety and Efficacy of AczoneTM
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`(dapsone) Gel, 5% in Subjects with Papulopustular Rosacea".
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`¯ Aczone twice a day was better than Aczone once a day
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`¯ Aczone twice a day was not significantly better than the vehicle gel twice a day
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`¯ Combining Aczone and M etrogel 1% was not significantly better than M etrogel 1%
`
`Recent Articles
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`on its own.
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`¯ None of any combination of the treatments was able to make a significant dent in
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`erythema or telangiectasia.
`
`Aclaris are the new owners of Rhofade
`
`Would you give 1+ years off your life for a cure?
`
`Raising the bar on rosacea treatment - we want to
`
`be clear!
`
`Galderma for sale -why we need the right buyer
`
`BioPharmX developing topical Minocycline Gel 1%
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`https://rosacea-support.org/aczone-fails-to-impress-for-rosacea.html
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`10/29/2018
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`1 of 4
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`Aczone Fails to Impress for Rosacea ¯ Rosacea Support Group
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`Page 2 of 4
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`Ta keaway Poi nts
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`Notch this up as another data point. Rosacea treatments are hard. Even established acne
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`treatments are no shoe-in to treat the papules and pustules of rosacea. Failures are going
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`to be more common than successes.
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`Further, bettering the existing established treaments of topical metronictazole, topical
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`Generic Oracea - sadly just not going to happen
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`UK Health Regulator warns about Mirvaso and
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`cardiovascular effects
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`Leo Pharma is the new owner of Finacea
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`How would you like Metrogel and Finacea to be
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`over the counter?
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`azelaic acid, systemic antibiotics is an extra hill to climb for emerging treatments.
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`Rosacea sufferers have higher cardio vascular
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`Allergan Isn’t Giving Up
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`Despite this set back, Allergan continues the research and development of new treatments
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`for several conditions.
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`For rosacea sufferers are considered, the most promising would be the Oxymetazoline
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`based topical that they call AG N-199201. This was formerly known as V-101 when it was
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`being development by Vicept Therapeutics.
`
`Related Articles
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`¯ FDA gets tough with Allergan over Aczone
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`¯ aczone (topical dapsone) recruiting trial participants
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`¯ Allergan buys Aczone, has plans for rosacea targeting ?
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`¯ New Drugs Cost $4b - $11 b To Develop
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`¯ Allergan Developing Oxymetazoline (AGN-199201/V-101 ) Cream Formulations
`
`aczone (topical dapsone)
`t ecruiting tt ial pal [icipa nts
`A large Phase II Clinical Trial for
`treating rosaeea with Aczone is
`looking for participants, The
`trial aims to compare Aczone
`(5% topical dapsone gel) with
`,~,::>~ I i: 2 ~:~)(
`Ii,
`i,i[:,:~:f,:,,i,::¢ [
`
`Allergan buys Aczone, has plans
`for r osacea talgeting ?
`OK this story is getting so much
`coverage in the online press
`tlqat I thought I should covel it
`here too. Allergan is buying the
`topical dapsone product called
`J J~,e I : ),:,
`Ii
`ri: ii ,m,, 1-~’
`
`Aczone Gel (5% Dapsone) gets
`FDA approval for Ache
`The LI.S. Food and Drug
`Administration (FDA) has
`approved Aczone (dapsone)
`Gel, 5% for tile topical
`treatment of acne vulgaris in
`~., ,) )’,
`h ,t,,
`{q,,,I ,,
`
`i~i ,’,)’
`
`o
`Read more about: Aczone (Dapsone Gel BY0), Allergan, clinical trials
`
`About the Author: David Pascoe started the Rosacea Support Group in ~j~
`
`October 1998. More from this author.
`
`( FOLLOW ROSACEASUPPORT )
`
`HD~j~
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