Claims for Patent: 11,690,914

Summary for Patent: 11,690,914

Title:	Methods for photodynamic therapy
Abstract:	A method of enhancing penetration of a topical composition of 5-aminolevulinic acid (ALA) into tissue for photodynamic therapy includes topically applying ALA to a treatment area to be treated with photodynamic therapy. The method further includes, after the ALA is applied to the treatment area, covering the treatment area with a low density polyethylene barrier. The treatment area is covered with the low density polyethylene barrier prior to light treatment to minimize transepidermal water loss from the treatment area.
Inventor(s):	Scott Lundahl, Michael Guttadauro
Assignee:	Sun Pharmaceutical Industries Inc
Application Number:	US17/876,224
Patent Claims:	1. A method of enhancing penetration of a topical composition of 5-aminolevulinic acid (ALA) into tissue for photodynamic therapy, the method comprising: topically applying ALA to a treatment area to be treated with photodynamic therapy; after the ALA is applied to the treatment area, covering the treatment area with a low density polyethylene barrier prior to light treatment to provide a transepidermal water loss rate from the treatment area of 1.11 g/m2 hr or less; and removing the low density polyethylene barrier after 3 hours and then applying light to the treatment area. 2. The method according to claim 1, wherein the covering the treatment area with a low density polyethylene barrier prior to light treatment provides a transepidermal water loss rate from the treatment area of 0.96 g/m2 hr or less. 3. The method according to claim 1, wherein the covering the treatment area with a low density polyethylene barrier prior to light treatment provides a transepidermal water loss rate from the treatment area of 0.67 g/m2 hr or less. 4. The method according to claim 1, wherein the barrier contacts the treatment area. 5. The method according to claim 1, further comprising: applying 5-aminolevulinic acid (ALA) to an actinic keratotic lesion on the stratum corneum of an upper extremity to provide a geometric mean area under a curve value of ALA, following application, of less than about 350 ng·hr/mL. 6. The method according to claim 5, wherein the treatment area is not heated prior to applying light to the treatment area. 7. The method according to claim 1, wherein the treatment area is covered with the barrier by conforming the barrier to the treatment area such that the barrier stays close to a surface of the treatment area. 8. The method according to claim 1, wherein the barrier comprises a two layer barrier wherein a top layer provides light pressure to keep a lower layer in place. 9. The method according to claim 1, wherein the low density polyethylene barrier is held in place with an elastic net. 10. The method according to claim 1, wherein the barrier is covered with material. 11. The method according to claim 1, wherein the barrier is covered with material by placing the material over and around the barrier. 12. The method according to claim 1, wherein the low density polyethylene barrier is removed within 3 hours and 18 minutes. 13. The method according to claim 1, wherein the treatment area is wet when the treatment area is covered with the low density polyethylene barrier. 14. The method according to claim 1, wherein the topical composition comprises a gel. 15. The method according to claim 1, wherein the light is red light. 16. The method according to claim 1, wherein the ALA is applied digitally. 17. The method according to claim 1, wherein the ALA is applied with a hand-held device. 18. The method according to claim 1, wherein the treatment area comprises an actinic keratotic lesion. 19. The method according to claim 1, wherein the treatment area is heated by about 2° C. prior to applying light to the treatment area. 20. A method of treating actinic keratosis comprising: applying 5-aminolevulinic acid (ALA) to an actinic keratotic lesion on the stratum corneum of an upper extremity; after the ALA is applied to the treatment area, covering the treatment area with a low density polyethylene barrier prior to light treatment to provide a transepidermal water loss from the treatment area of 1.11 g/m2 hr or less; and removing the low density polyethylene barrier after 3 hours and then applying light to the treatment area. 21. A method of treating actinic keratosis comprising: applying 5-aminolevulinic acid (ALA) to an actinic keratotic lesion on the stratum corneum of an upper extremity to provide a maximum plasma concentration of ALA of less than about 110 ng/mL, following application of the ALA to the lesion; covering a treatment area including the lesion with a low density polyethylene barrier prior to light treatment to provide a transepidermal water loss rate from the treatment area of 1.11 g/m2 hr or less; and removing the low density polyethylene barrier after 3 hours and then applying light to the treatment area.