TREATMENT AND PROPHYLAXIS OF RADIATION DERMATITIS
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 .