Treatment of chronic ulcers
The present invention provides a pharmaceutical formulation comprising LL-37 or a pharmaceutically-acceptable salt thereof and one or more pharmaceutically-acceptable diluent or carrier system, for use in a method of treatment of a chronic ulcer wound (such as a hard-to-heal venous leg ulcer or a diabetic foot ulcer), which method comprises: (a) topical application of the formulation to the ulcer; followed by (b) application of a dressing, and wherein the application of the formulation provides for a dose of LL-37 at the wound site that is below about 80 μg of LL-37 applied per cm 2 of wound area, and/or below about 26.7 μg of LL-37 applied per cm 2 of wound area, per day of treatment.
1. A method of treating a chronic ulcer, wherein said method comprises: topically applying to said chronic ulcer a pharmaceutical formulation, wherein the pharmaceutical formulation is an aqueous solution comprising LL-37 or a pharmaceutically-acceptable salt thereof, wherein the pharmaceutical formulation comprises one thickening agent, wherein the dose of LL-37 applied per cm 2 of wound area is between about 1 μg/cm 2 and about 70 μg/cm 2 , and wherein the pharmaceutical formulation has a viscosity in the range of about 2 and about 10 Pa·s.
2. The method as claimed in claim 1 , wherein the dose of LL-37 applied per cm 2 of wound area is between about 5 μg/cm 2 and about 60 μg/cm 2 .
3. The method as claimed in claim 1 , further comprising subsequently and separately applying a dressing to said chronic ulcer.
4. The method as claimed in claim 3 , wherein the dressing is applied within no less than about 5 minutes and no more than about 30 minutes of the application of the pharmaceutical formulation.
5. The method as claimed in claim 2 , further comprising subsequently and separately applying a dressing to said chronic ulcer.
6. The method as claimed in claim 5 , wherein the dressing is applied within no less than about 5 minutes and no more than about 30 minutes of the application of the pharmaceutical formulation.
7. A method of treating a chronic ulcer, wherein said method comprises: topically applying to said chronic ulcer a pharmaceutical formulation, wherein the pharmaceutical formulation is an aqueous solution comprising LL-37 or a pharmaceutically-acceptable salt thereof, wherein the pharmaceutical formulation comprises one thickening agent; wherein the dose of LL-37 applied per cm 2 of wound area is between about 0.3 μg/cm 2 and about 23.3 μg/cm 2 per day of treatment, and wherein the pharmaceutical formulation has a viscosity in the range of about 2 and about 10 Pa·s.
8. The method as claimed in claim 7 , wherein the dose of IL-37 applied is between about 1.6 μg/cm 2 and about 20 μg/cm 2 per day of treatment.
9. The method as claimed in claim 7 , further comprising subsequently and separately applying a dressing to said chronic ulcer.
10. The method as claimed in claim 9 , wherein the dressing is applied within no less than about 5 minutes and no more than about 30 minutes of the application of the pharmaceutical formulation.
11. The method as claimed in claim 8 , further comprising subsequently and separately applying a dressing to said chronic ulcer.
12. The method as claimed in claim 11 , wherein the dressing is applied within no less than about 5 minutes and no more than about 30 minutes of the application of the pharmaceutical formulation.
13. The method as claimed in claim 1 , wherein the chronic ulcer is a venous leg ulcer.
14. The method as claimed in claim 1 , wherein the chronic ulcer is a diabetic foot ulcer.
15. The method as claimed in claim 2 , wherein the chronic ulcer is a venous leg ulcer.
16. The method as claimed in claim 2 , wherein the chronic ulcer is a diabetic foot ulcer.
17. The method as claimed in claim 7 , wherein the chronic ulcer is a venous leg ulcer.
18. The method as claimed in claim 7 , wherein the chronic ulcer is a diabetic foot ulcer.
19. The method as claimed in claim 8 , wherein the chronic ulcer is a venous leg ulcer.
20. The method as claimed in claim 8 , wherein the chronic ulcer is a diabetic foot ulcer.
21. A method as claimed in claim 1 , wherein the pharmaceutical formulation comprises one thickening agent being polyvinyl alcohol.
22. A method as claimed in claim 2 , wherein the pharmaceutical formulation comprises one thickening agent being polyvinyl alcohol.
23. A method as claimed in claim 7 , wherein the pharmaceutical formulation comprises one thickening agent being polyvinyl alcohol.
24. A method as claimed in claim 8 , wherein the pharmaceutical formulation comprises one thickening agent being polyvinyl alcohol.