Claims for Patent: 9,789,078

Summary for Patent: 9,789,078

Title:	Method of topically treating actinic keratosis with ingenol mebutate cycle therapy
Abstract:	The present invention relates to cyclic or repeated use of the ingenol mebutate for topical treatment of actinic keratosis lesions. Generally speaking, the present invention comprises a first ingenol mebutate treatment cycle and a second ingenol mebutate treatment cycle, wherein the first treatment cycle topically treats a treatment area with a topical gel formulated with ingenol mebutate at a selected dosage strength for a specified treatment regimen, and the second ingenol mebutate treatment cycle comprises topically re-treating the treatment area with the same topical ingenol mebutate gel for the same specified treatment regimen, if following the first treatment cycle, the treatment area failed to clear or failed to remain clear of AK lesions. The present invention further relates to spot or individual lesion therapy in the treatment area following the topical bi-cyclic therapy with ingenol mebutate.
Inventor(s):	Norrelund; Kirsten (Ballerp, DK)
Assignee:	LEO Laboratories Limited (Dublin, IE)
Application Number:	14/401,492
Patent Claims:	1. A method for topically treating a subject diagnosed with actinic keratosis lesions in a treatment area, said method comprising administering topically more than one treatment cycle of ingenol mebutate to the treatment area, each treatment cycle separated by an interval without treatment. 2. The method of claim 1, wherein at least two treatment cycles are administered. 3. The method according to claim 1, wherein said ingenol mebutate is administered as a topical formulation comprising ingenol mebutate 0.015%, by weight, and is applied to the face or scalp of a subject. 4. The method according to claim 1, wherein the treatment area has a size of up to about 25 cm.sup.2. 5. The method according to claim 1, wherein the interval without treatment is at least 8 weeks. 6. The method according to claim 1, wherein complete clearance of actinic keratosis lesions in the treatment area is obtained. 7. The-method according to claim 1, wherein complete clearance of the actinic keratosis lesions in the treatment area is obtained as evaluated 12 months after the first treatment cycle is initiated. 8. The method according to claim 2, wherein said ingenol mebutate is administered as a topical formulation comprising ingenol mebutate 0.015%, by weight, and is applied to the face or scalp of a subject. 9. The method according to claim 2, wherein the treatment area has a size of up to about 25 cm.sup.2. 10. The method according to claim 3, wherein the treatment area has a size of up to about 25 cm.sup.2. 11. The method according to claim 2, wherein the two treatment cycles are separated by at least 8 weeks. 12. The method according to claim 3, wherein the treatment cycles are separated by at least 8 weeks. 13. The method according to claim 4, wherein the treatment cycles are separated by at least 8 weeks. 14. The method according to claim 2, wherein complete clearance of actinic keratosis lesions in the treatment area is obtained. 15. The method according to claim 3, wherein complete clearance of actinic keratosis lesions in the treatment area is obtained. 16. The method according to claim 4, wherein complete clearance of actinic keratosis lesions in the treatment area is obtained. 17. The method according to claim 5, wherein complete clearance of actinic keratosis lesions in the treatment area is obtained. 18. The method according to claim 2, wherein complete clearance of the actinic keratosis lesions in the treatment area is obtained as evaluated 12 months after the first treatment cycle is initiated. 19. The method according to claim 3, wherein complete clearance of the actinic keratosis lesions in the treatment area is obtained as evaluated 12 months after the first treatment cycle is initiated. 20. The method according to claim 4, wherein complete clearance of the actinic keratosis lesions in the treatment area is obtained as evaluated 12 months after the first treatment cycle is initiated. 21. The method according to claim 5, wherein complete clearance of the actinic keratosis lesions in the treatment area is obtained as evaluated 12 months after the first treatment cycle is initiated. 22. The method according to claim 6, wherein complete clearance of the actinic keratosis lesions in the treatment area is obtained as evaluated 12 months after the first treatment cycle is initiated. 23. A method for topically treating a subject diagnosed with actinic keratosis lesions in a treatment area on the face or scalp of the subject, said method comprising: applying a topical formulation containing ingenol mebutate in an amount of 0.15% by weight to the actinic keratosis lesions in the treatment area in more than one treatment cycle to treat the actinic keratosis lesions; wherein the treatment area has a size of up to about 25 cm.sup.2; wherein each treatment cycle separated by an interval without treatment and wherein complete clearance of the actinic keratosis lesions is obtained in the treatment area. 24. A method of claim 23, wherein said method comprises a first treatment cycle and a second treatment cycle. 25. A method of claim 24, wherein the first and second treatment cycles are separated by 8 weeks. 26. A method of claim 25, wherein the complete clearance of the actinic keratosis lesions in the treatment area is obtained as evaluated at 12 months after initiation of the first treatment cycle. 27. A method of claim 1, wherein said treatment cycle includes daily topical administration of ingenol mebutate for three consecutive days. 28. A method of claim 23, wherein said treatment cycle includes daily topical administration of ingenol mebutate for three consecutive days.