Compositions of aluminum fluoride and methods of use thereof for the treatment and prevention of actinic keratosis and sun-induced damages

Abstract

The present invention is directed to methods and compositions for the treatment or prevention of actinic keratosis and/ or for countering the effects of skin aging and/ or damage to blood vessels and fine wrinkling. The present invention provides for a composition comprising aluminum fluoride or chemical compounds which releases aluminum fluoride to be used to treat or reduce the negative effects of actinic keratosis or sun-induced skin aging and associated conditions, for example, damaged blood vessels and fine wrinkling.

That which is claimed is: 
     
         1 . A topical composition for treating actinic keratosis or sun damaged skin comprising aluminum fluoride based drug, a pharmaceutically acceptable salt thereof, or a combination of compounds which allow for the release of aluminum fluoride in vivo, in a therapeutically effective amount sufficient to reduce the effects of actinic keratosis and wherein the therapeutically effective amount is from about 0.10% to about 0.75% per weight of composition. 
     
     
         2 . The topical composition according to  claim 1 , wherein the actinic keratosis is actinic cheilitis, inflammatory actinic keratosis, hypertrophic keratosis or pigmentary keratosis. 
     
     
         3 . The topical composition according to  claim 1 , wherein the therapeutically effective amount is from about 0.25% to about 0.60% w/w per weight. 
     
     
         4 . The topical composition according to  claim 1 , wherein the aluminum fluoride based drug is combined with a pharmaceutical carrier. 
     
     
         5 . The topical composition according to  claim 1 , where the topical composition further comprises a carrier comprising at least two, three, four or five inactive ingredients selected from the group consisting of montanov 202, capric/caprilic triglyceride, isopropyl palmitate, methylisothiazolinone and sodium benzoate Caprylic/Capric acids; medium chain triglycerides, PEG 400, PEG 3350, Poloxamer F127 and Pluronic F127. 
     
     
         6 . The topical composition according to  claim 1 , wherein the aluminum fluoride compound is the sole active agent in the composition. 
     
     
         7 . A composition formulated for topical application comprising an aluminum fluoride based drug, a pharmaceutically acceptable salt thereof, or a combination of compounds which allow for the release of aluminum fluoride in vivo in a concentration of about 0.10% to about 0.75% w/w; and
 at least two of the following components selected from the group consisting of:   at least one emollient in a concentration of about 5% to about 60% w/w;   at least one thickener in a concentration of about 0.5% to about 20% w/w;   at least one preservative in a concentration of about 0.01% to about 10% w/w;   at least one surfactant in a concentration of about 1% to about 20%; and   water from about 2% to 80% w/w.