Aczone is as good as Oracea, Finacea or Metrogel, apparently

aczone-box

Trolling patent applications is pretty turgid work. Mostly patents seem to be intellectuals marking out their claims in the hope that future products might result from their discoveries.

This patent application starts badly with firstly spelling Rosacea incorrectly as Rosascea. Pretty embarrassing Allergan ! To save you from seeing this misspelling again I’ll spell it correctly in the extract below.

Sometimes you find interesting information at the bottom of patent applications – where applicants sometimes provide proof that their invention works. In this patent application we find claims that Dapsone is as good as Finacea, Oracea, Metrogel 1% at reducing the facial lesions associated with rosacea.

Allergan, the makers of Aczone, are listed as the owner of this patent.

Back in June 2008 I wondered if Allergan buying Aczone, meant that they had plans for rosacea targeting. In August 2009 Allergan was warned by the FDA for overstating the efficacy and underplaying the risks of Aczone.

Patent Application 20100310480

DAPSONE TO TREAT ROSACEA

The methods described herein provide treatment of rosacea using topical formulations of dapsone. The methods also provide treatment of rosacea with topical dapsone in combination with other active agents, including metronidazole. The methods avoid negative hematologic side effects, including hemolysis and hemolytic anemia, that are associated with oral administration of dapsone.

[0007] In a preferred embodiment, the pharmaceutical composition is a semisolid aqueous gel. The semisolid aqueous gel includes a thickening agent, water, a solvent, preservative, microparticulate dapsone, dissolved dapsone, and caustic material. In a preferred embodiment, the caustic material is a base agent. In a preferred embodiment, the composition exhibits an optimal balance between dissolved dapsone that is available to cross through the stratum corneum of the epidermis and be absorbed into the lower two-thirds of the pilosebaceous unit; and microparticulate dapsone that is retained in or above the stratum corneum to serve as a reservoir or to provide dapsone to the supracorneum zone, crossing the stratum corneum of the epidermis only minimally as a solid. The solid microparticulate dapsone reservoir is slowly dissolved in body fluids before it is delivered through the stratum corneum

[0048] Currently, use of oral dapsone is generally limited, as its use may be associated with hematologic side effects, including hemolysis and hemolytic anemia that are dose-dependent and occur more frequently with increasing dose (Zhu and Stiller 2001; Jollow et al., 1995). The mechanism of dapsone-related hemolysis and hemolytic anemia involves oxidative damage to red blood cells and is associated with the dapsone hydroxylamine metabolite (Prendiville et al., 1988).

[0109] A review of historical results for other approved therapies shows that the mean changes from baseline in lesion count for the dapsone 2 timesa day group was close to that of other approved products for rosacea, including Finacea,(azelaic acid) Gel, 15%, Oracea  (doxycycline) 40 mg capsules, and the active comparator in this study, MetroGel (metronidazole), 1.0%.

See the Aczone Prescribing Information for the official list of indications, contraindications and known side effects for this treatment. The official web site for Aczone is at aczone.com. According to Allergan, women fare better on Aczone. See the Efficacy page for examples of the sorts of improvements that you might expect from Aczone after 12 weeks use.

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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