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(12) Patent Application Publication (10) Pub. No.: US 2011/0294.896 A1 Garret (43) Pub US 2011 O294.896A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0294.896 A1 Garret (43) Pub. Date: Dec. 1, 2011 (54) TOPCAL TREATMENT WITH DAPSONE IN Publication Classification G6PD-DEFICIENT PATIENTS (51) Int. Cl. A6II 3/145 (2006.01) A6IP 7/10 (2006.01) (76) Inventor: John S. Garret, Fort Collins, CO A6IP 700 (2006.01) (US) (52) U.S. Cl. ........................................................ 514/646 (57) ABSTRACT (21) Appl. No.: 12/741,927 The present invention provides a pharmaceutical carrier sys tem comprising a dermatological composition that is a semi Solid aqueous gel, wherein dapsone is dissolved in the gel (22) PCT Fled: Nov. 7, 2007 Such that the dapsone has the capacity to cross the stratum corneum layer of the epidermis, and wherein the composition also contains dapsone in a microparticulate state that does not (86) PCT NO.: PCT/USO7/23468 readily cross the stratum corneum of the epidermis. The present invention also discloses the treatment of dermatologi S371 (c)(1), cal conditions in G6PD-deficient patients with the composi (2), (4) Date: Aug. 15, 2011 tion, while avoiding adverse hematologic effects. Patent Application Publication Dec. 1, 2011 Sheet 1 of 5 US 2011/0294.896 A1 Figure 1 756 Subjects Screened for G6PD Deficiency 686 subjects not G6PD deficient 6 subjects withdrew consent N= 64 Subjects Randomized Vehicle -> Dapsone gel sequence Dapsone gel -> Vehicle sequence N=32 (100%) N=32 (100%) - - Treatment Period 1: Vehicle Treatment Period 1: Dapsone gel Completed n=29 (91%) Completed n=25 (78%) Treatment Period 2: Dapsone gel Treatment Period 2: Vehicle Completed n=26 (81%) Completed n=21 (66%) Safety-evaluable n=31 Safety-evaluable n=25 Patent Application Publication Dec. 1, 2011 Sheet 2 of 5 US 2011/0294.896 A1 Figure 2 Change in Hb (gldL) Patent Application Publication Dec. 1, 2011 Sheet 3 of 5 US 2011/0294.896 A1 Figure 3 0.25 () () -0.75 -1.25 Change in Hb (g/dL) Patent Application Publication Dec. 1, 2011 Sheet 4 of 5 US 2011/0294.896 A1 Figure 4 5. -0.25 -0.50 -0.75 Change in Hb (g/dL) Patent Application Publication Dec. 1, 2011 Sheet 5 of 5 US 2011/0294.896 A1 Figure 5 Change in Hb (g/dL) US 2011/0294.896 A1 Dec. 1, 2011 TOPCAL TREATMENT WITH DAPSONE IN for treating dermatological conditions in a glucose-6-phos G6PD-DEFICIENT PATIENTS phate dehydrogenase-deficient patient are also contemplated by the present invention. 0006. The present invention provides a pharmaceutical BACKGROUND OF THE INVENTION carrier system comprising a dermatological composition that is a semi-solid aqueous gel, wherein dapsone is dissolved in 0001 Dapsone is a sulfone with both anti-inflammatory the gel Such that the dapsone has the capacity to cross the and antimicrobial properties. The oral formulation of the drug stratum corneum layer of the epidermis and become available is used to treat leprosy, dermatitis herpetiformis, and malaria, systemically, and wherein the composition also contains dap using typical doses of 100 mg to 300 mg daily, but histori Sone in a microparticulate state that does not readily cross the cally, it was also used to treat severe acne in doses ranging stratum corneum of the epidermis. The ratio of microparticu from 50 mg/day to 300 mg/week (Wolf et al., 2002; Ross late to dissolved dapsone is adjustable, but is preferably five 1961; Prendiville et al., 1988). Currently, use of oral dapsone or less. Second medical uses of the dermatological composi is generally limited to more severe forms of skin disease, as its tion and methods of manufacture of a medicament for treating use may be associated with hematologic side effects, includ dermatological conditions in a glucose-6-phosphate dehy ing hemolysis and hemolytic anemia that are dose-dependent drogenase-deficient patient using the dermatological compo and occur more frequently with increasing dose (Zhu and sition are also contemplated by the present invention. Stiller 2001; Jollow et al., 1995). 0007. In some embodiments, the dermatological compo 0002 The mechanism of dapsone-related hemolysis and sition for use in methods of treating glucose-6-phosphate hemolytic anemia involves oxidative damage to red blood dehydrogenase-deficient patients includes a thickening cells and is associated with the dapsone hydroxylamine agent; water, a high-boiling, nonionic organic solvent; a pre metabolite (Prendiville et al., 1988). Red blood cells are servative; dapsone in a microparticulate and dissolved State; Somewhat protected against oxidative injury and lysis by and a base solution. In one preferred embodiment, the com glutathione reduction, a metabolic pathway that involves the position includes about 0.5% to 4.0% carbomer; about 53.8% glucose-6-phosphate dehydrogenase (G6PD) enzyme. Con to 84.2% water; about 10% to 30% ethoxydiglycol; about sequently, individuals who are G6PD-deficient are more sen 0.2% methylparaben; about 5% to 10% dapsone in a micro sitive to developing hemolytic anemia after exposure to particulate and dissolved state; and about 0.1% to 2% sodium hemolytic stressors such as infection, administration of a hydroxide solution. In some embodiments, the composition variety of drugs, including dapsone, oringestion of fava beans includes about 1% carbomer; about 81.8% water; about 10% (Beutler 1994). G6PD deficiency is most prevalent in indi ethoxydiglycol; about 0.2% methylparaben; about 5% dap viduals of African, Southeast Asian, and Middle Eastern heri Sone in a microparticulate and dissolved state; and about 2% tage, and because the G6PD enzyme is encoded on the X sodium hydroxide solution. In another preferred embodi chromosome, the deficiency is more common in males. In the ment, the dermatological composition includes about 0.85% United States, a recent study of military personnel reported carbomer; about 66.95% water; about 25% diethylene glycol the prevalence of G6PD deficiency to be 2.5% in men and monoethyl ether; about 0.2% methylparaben; about 5% dap 1.6% in women (Chinevere et al., 2006). Amongst racial sone; and about 0.2% sodium hydroxide. Second medical groups, the prevalence was highest in African American men uses of the dermatological composition and methods of (12.2%), Asian men (4.3%), and African American women manufacture of a medicament for treating dermatological (4.1%), and lowest in Caucasian men and women (0.3% and conditions in a glucose-6-phosphate dehydrogenase-defi Zero, respectively). An early study that compared the effects cient patient using the dermatological composition are also of oral dapsone treatment in G6PD-deficient and non-defi contemplated by the present invention. cient men found that there was a direct, linear relationship 0008. In certain embodiments, the invention provides a between oral dapsone dose and extent of red blood cell method to treat a dermatological condition in a glucose-6- hemolysis in both the normal and deficient groups. The doses phosphate dehydrogenase-deficient patient comprising causing hemolysis in G6PD-deficient subjects were approxi applying topically a dermatological gel composition that mately half of the doses that caused hemolysis in subjects includes a semisolid aqueous gel; dapsone dissolved in the with normal G6PD levels (DeGowin et al., 1966). gel, wherein the dapsone has the capacity to cross the stratum 0003) What is needed is a method of treating dermatologi corneum layer of the epidermis and become available sys cal conditions in patients including G6PD-deficient patients temically, and a microparticulate dapsone dispersed in the without the adverse hematologic effects associated with oral gel, wherein the microparticulate dapsone does not cross the dapsone administration. stratum corneum of the epidermis in its microparticulate state. The dermatological condition can include inflamma SUMMARY OF THE INVENTION tory acne, non-inflammatory acne and/or rosacea. 0009. In embodiments where acne is treated, the acne can 0004. The present invention provides methods to treat glu be non-inflammatory acne, inflammatory acne, or both. In cose-6-phosphate dehydrogenase-deficient patients with Some embodiments, the dermatological dapsone composition dapsone. In one embodiment, the treatment is directed to is a semisolid aqueous gel. In other embodiments, the derma dermatological conditions and the treatment is provided by a tological dapsone composition is a cream or a lotion. In still topical dapsone composition. The composition may include other embodiments, the dapsone composition is a Suspension, dissolved dapsone and microparticulate dapsone. In certain ointment, or spray. In each of these embodiments, the dap embodiments, the dermatological condition to be treated is Sone may exist as a microparticulate form, a dissolved form, inflammatory acne, non-inflammatory acne or rosacea. or both. 0005 Second medical uses of the dapsone composition 0010. In a preferred embodiment, the invention provides a and methods of manufacture using the dapsone composition method to treat a dermatological condition in a glucose-6- US 2011/0294.896 A1 Dec. 1, 2011 phosphate dehydrogenase-deficient patient by applying a der unit, crossing the stratum corneum of the epidermis only matological composition to the condition, wherein the der minimally. Second medical uses of the dermatological com matological composition includes dapsone, wherein the position and methods of manufacture of a medicament for method results in blood plasma levels of dapsone and treating dermatological conditions in a glucose-6-phosphate N-acetyl dapsone below the levels associated with hemolysis. dehydrogenase-deficient patient using the gel composition Second medical uses of the dermatological composition and are also contemplated by the present invention. methods of manufacture of a medicament for treating derma 0016. The use of a dermatological composition compris tological conditions in a glucose-6-phosphate dehydroge ing about 0.85% carbomer; about 66.95% water; about 25% nase-deficient patient using the dermatological composition ethoxydiglycol; about 0.2% methylparaben; about 5% dap are also contemplated by the present invention.
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