Treatment and prophylaxis of radiation dermatitis

Abstract

The present disclosure relates to topical formulations comprising purified water, milk protein fluid and thickener, in particular a hydrogel and a lotion, and their use in treatment of radiation dermatitis, in particular in a two-step process for the treatment of radiation dermatitis.

1 . A topical formulation for the prophylaxis and/or treatment of radiation dermatitis comprising purified water, milk protein fluid and thickener. 
     
     
         2 . A topical formulation according to  claim 1  wherein the viscosity is in the range 25,000 CPS to 510,000 CPS, for example 25,000 CPS to 130,000 CPS or 290,000 CPS to 510,000 CPS. 
     
     
         3 . A topical formulation according to  claim 1  comprising 4-8% milk protein, for example wherein the milk protein fluid is lactokine. 
     
     
         4 . A topical formulation according to  claim 1  further comprising a preservative, for example 0.5-1.2% preservative, such as phenoxyethanol and ethylhexylglycerine. 
     
     
         5 . A topical formulation according to  claim 1  further comprising up to 1% chelating agent, such as edetate disodium. 
     
     
         6 . A topical formulation according to  claim 1  wherein the formulation is a hydrogel further comprising one or more ingredients selected from: carbomer such as carbomer 940 and/or carbomer T 1, pH modifier such as trolamine, and moisturising agent such a glycerine. 
     
     
         7 . A hydrogel according to  claim 6  consisting essentially of:
 89-93.5% purified water, 
 4-8% milk protein fluid, 
 0.5-1.15% glycerine, 
 0.1-3.5% trolamine, 
 0.5-1.2% preservative, 
 0.1-0.9% carbomer, 
 0.25-0.85% thickener, and 
 0-1% edetate disodium. 
 
     
     
         8 . A hydrogel according to  claim 6  wherein the thickener is acrylate/Cio-30 a′  acrylate crosspolymer. 
     
     
         9 . A hydrogel according to  claim 6  consisting essentially of:
 91.15% purified water, 
 5% lactokine, 
 1% glycerine, 
 0.8% trolamine, 
 0.75% phenoxyethanol and ethylhexylglycerine, 
 0.4% carbomer 940, 
 0.3% carbomer TR1, 
 0.5% acrylate/C 10-30  alkyl acrylate crosspolymer, and 
 0.1% edetate disodium 
 and wherein the viscosity is in the range 290,000 to 510,000 cP. 
 
     
     
         10 . A hydrogel according to  claim 6  wherein the hydrogel has high thermal capacity. 
     
     
         11 . A topical formulation according to  claim 1  wherein the formulation is a lotion further comprising one or more ingredients selected from:
 non-metallic UVA and/or UVB inhibitor such as octocrylene, octinoxate, homosalate or avobenzone or a mixture thereof, 
 C 12-15  alkyl benzoate, 
 caprylyl methicone, 
 emulsifier such as ceteareth-20 and ceteryl alcohol, 
 gelling agent such as ammonium acrylolydimethyltaurate/VP copolymer, 
 glyceryl monostearate such as glyceryl stearate SE and/or glyceryl stearate, and glyceryl stearate citrate. 
 
     
     
         12 . A lotion according to  claim 11  consisting essentially of:
 7-19% non-metallic UVA and/or UVB inhibitor, 
 54.5-65.5% purified water, 
 6-15% C 12-15  alkyl benzoate, 
 4-8% milk protein fluid, 
 1-5% caprylyl methicone, 
 1-2.5% emulsifier, 
 0.25-1.25% gelling agent, 
 1-2.5% glyceryl monostearate, 
 1-2.5% glyceryl stearate citrate, 
 0.5-1.2% preservative, 
 0-1% edetate disodium, and 
 2% thickener. 
 
     
     
         13 . A lotion according to  claim 11  wherein the non-metallic UVA and/or UVB inhibitors are octocrylene, octinoxate and avobenzone. 
     
     
         14 . A lotion according to  claim 11  wherein the thickener is corn starch. 
     
     
         15 . A lotion according to  claim 11  consisting essentially of:
 10% octocrylene, 
 3% octinoxate, 
 3% avobenzone, 
 58.8% purified water, 
 8% C 12-15  alkyl benzoate, 
 5% lactokine, 
 4% caprylyl methicone, 
 1% ceteareth-20 and ceteryl alcohol, 
 0.7% ammonium acrylolydimethyltaurate/VP copolymer, 
 1% glyceryl stearate SE, 
 1.2% glyceryl stearate, 
 1% glyceryl stearate citrate, 
 1% phenoxyethanol and ethylhexylglycerine, 
 0.2% edetate disodium, and 
 2% corn starch 
 and wherein the viscosity is in the range 25,000 to 130,000 cP. 
 
     
     
         16 . A two-step process for the prophylaxis and/or treatment of radiation dermatitis comprising the steps:
 a) applying a generous layer of the hydrogel of  claim 6  to unbroken skin following radiation therapy and leaving it on the skin for at least 20 minutes;   b) applying the lotion of  claim 11  unbroken skin to provide moisturisation;   wherein step b) is repeated as often as desired to relieve discomfort.   
     
     
         17 . A kit of parts comprising at least one application of the hydrogel formulation of  claim 6 . 
     
     
         18 . A method of prophylaxis and/or treatment for radiation dermatitis comprising administering to patient in need thereof the hydrogel of  claim 6 .