Treatment and prophylaxis of radiation dermatitis

1. A process for addressing radiation dermatitis comprising the steps of:

a) applying a layer of hydrogel to unbroken skin following radiation therapy and leaving the hydrogel thereon for at least 20 minutes; and

b) applying lotion to the unbroken skin to provide moisturisation;

wherein step b) is repeated as often as desired to relieve discomfort;

wherein the hydrogel is a topical formulation comprising purified water, milk protein fluid and thickener, and one or more ingredients selected from: a polyacrylic acid, pH modifier, and moisturising agent;

wherein the lotion is a topical formulation comprising purified water, milk protein fluid and thickener, and one or more ingredients selected from: non-metallic UVA inhibitor, non-metallic UVB inhibitor, a skin conditioning agent, emulsifier, gelling agent, solvent, mineral oil, pH modifier and phosphate buffer; and

wherein the lotion consists essentially of:

7-19% weight/weight (w/w) non-metallic UVA or UVB inhibitor,

54.5-65.5% w/w purified water,

6-15% w/w C 12-15 alkyl benzoate,

4-8% w/w milk protein fluid,

1-5% w/w caprylyl methicone,

1-2.5% w/w emulsifier,

0.25-1.25% w/w gelling agent,

1-2.5% w/w glyceryl monostearate,

1-2.5% w/w glyceryl stearate citrate,

0.5-1.2% w/w preservative,

0-1% w/w edetate disodium, and

2% w/w thickener.

2. The process according to claim 1 , wherein the hydrogel is applied after radiation therapy to a part of the skin that has received radiation therapy, and the lotion is applied after the hydrogel within about 1 to 6 hours after radiation therapy to the same part of the skin that has received the radiation therapy.

3. The process according to claim 2 , wherein when radiation therapy is applied in a daily dose, the hydrogel is applied once after each daily dose of radiation therapy and the lotion is applied 1 to 10 times per day.

4. The process according to claim 3 , wherein the lotion is applied 2 to 6 times per day.

5. The process according to claim 1 , wherein the hydrogel is wiped off the skin or absorbed into the skin before application of the lotion.

6. The process according to claim 1 , wherein the process is repeated daily for 3 to 5 weeks, following radiation treatment.

7. The process according to claim 1 , wherein,

in the hydrogel, the pH modifier comprises triethanolamine; and

the moisturising agent is selected from the group consisting of glycerine, sorbitol, polyethylene glycols, urea, and propylene glycol.

8. The process according to claim 1 , wherein a viscosity of the lotion is in the range of 25,000 CPS to 130,000 CPS and a viscosity of the hydrogel is in the range of 290,000 cP to 510,000 cP.

9. The process according to claim 1 , wherein the hydrogel comprises 4-8% w/w milk protein fluid.

10. The process according to claim 1 , wherein the hydrogel and/or the lotion further comprises a preservative selected from phenoxyethanol and ethylhexylglycerine.

11. The process according to claim 1 , wherein the hydrogel comprises up to 1% w/w chelating agent.

12. The process according to claim 1 , wherein the hydrogel consists essentially of:

89-93.5% w/w purified water,

4-8% w/w milk protein fluid,

0.5-1.15% w/w glycerine,

0.1-3.5% w/w triethanolamine,

0.5-1.2% w/w preservative,

0.1-0.9% w/w polyacrylic acid),

0.25-0.85% w/w thickener, and

0-1% w/w edetate disodium.

13. The process according to claim 12 , wherein the thickener is acrylate/C 10-30 alkyl acrylate crosspolymer.

14. The process according to claim 1 , wherein the hydrogel consists essentially of:

91.15% w/w purified water,

5% w/w milk protein fluid,

1% w/w glycerine,

0.8% w/w triethanolamine,

0.75% w/w phenoxyethanol and ethylhexylglycerine,

0.7% w/w polyacrylic acid,

0.5% w/w acrylate/C 10-30 alkyl acrylate crosspolymer, and

0.1% w/w edetate disodium and wherein a viscosity of the hydrogel is in the range 290,000 to 510,000 cP.

15. The process according to claim 1 , wherein the lotion consists essentially of

10% w/w octocrylene,

3% w/w octinoxate,

3% w/w avobenzone,

58.8% w/w purified water,

8% w/w C 12-15 alkyl benzoate,

5% w/w milk protein fluid,

4% w/w caprylyl methicone,

1% w/w ceteareth-20 and ceteryl alcohol,

0.7% w/w ammonium acrylolydimethyltaurate/vinyl pyrrolidone copolymer,

1% w/w glyceryl stearate self-emulsifying,

1.2% w/w glyceryl stearate,

1% w/w glyceryl stearate citrate,

1% w/w phenoxyethanol and ethylhexylglycerine,

0.2% w/w edetate disodium, and

2% w/w corn starch

and wherein a viscosity of the lotion is in the range of 25,000 to 130,000 cP.

16. A process for addressing radiation dermatitis comprising the steps of:

a) applying a layer of hydrogel to unbroken skin following radiation therapy and leaving the hydrogel on the skin for at least 20 minutes; and

b) applying a lotion to the unbroken skin to provide moisturisation;

wherein step b) is repeated as often as desired to relieve discomfort;

wherein the hydrogel is a topical formulation comprising purified water, milk protein fluid and thickener, a polyacrylic acid, a pH modifier comprising trolamine, and a moisturising agent comprising a glycerine;

wherein the lotion is a topical formulation comprising purified water, milk protein fluid and thickener, non-metallic UVA or non-metallic UVB inhibitor, a skin conditioning agent, emulsifier, gelling agent, solvent, mineral oil, pH modifier and phosphate buffer and

wherein the lotion consists essentially of:

7-19% weight/weight (w/w) non-metallic UVA or UVB inhibitor,

54.5-65.5% w/w purified water,

6-15% w/w C 12-15 alkyl benzoate,

4-8% w/w milk protein fluid,

1-5% w/w caprylyl methicone,

1-2.5% w/w emulsifier,

0.25-1.25% w/w gelling agent,

1-2.5% w/w glyceryl monostearate,

1-2.5% w/w glyceryl stearate citrate,

0.5-1.2% w/w preservative,

0-1% w/w edetate disodium, and

2% w/w thickener.

17. A process for addressing radiation dermatitis comprising the steps of:

a) applying a layer of hydrogel to unbroken skin following radiation therapy and leaving the hydrogel on the skin for at least 20 minutes; and

b) applying a lotion to unbroken skin to provide moisturisation;

wherein step b) is repeated as often as desired to relieve discomfort;

wherein when radiation therapy is applied in a daily dose, the hydrogel is applied once after each daily dose of radiation therapy and the lotion is applied 1 to 10 times per day;

wherein the hydrogel is a topical formulation comprising purified water, milk protein fluid and thickener and the hydrogel has a viscosity is in the range 290,000 to 510,000 cP;

wherein the lotion is a topical formulation comprising purified water, milk protein fluid and thickener, the lotion having a viscosity is in the range 25,000 to 130,000 cP; and

wherein the lotion consists essentially of:

7-19% w/w non-metallic UVA or UVB inhibitor,

54.5-65.5% w/w purified water,

6-15% w/w C 12-15 alkyl benzoate,

4-8% w/w milk protein fluid,

1-5% w/w caprylyl methicone,

1-2.5% w/w emulsifier,

0.25-1.25% w/w gelling agent,

1-2.5% w/w glyceryl monostearate,

1-2.5% w/w glyceryl stearate citrate,

0.5-1.2% w/w preservative,

0-1% w/w edetate disodium, and

2% w/w thickener.