Methods for photodynamic therapy

• US 10,357,567 B1
• Filed: 01/12/2018
• Issued: 07/23/2019
• Est. Priority Date: 01/12/2018
• Status: Active Grant

• Current Assignee: Dusa Pharmaceuticals (Sun Pharmaceutical Industries Limited)
• Original Assignee: Dusa Pharmaceuticals (Sun Pharmaceutical Industries Limited)
• Inventors: Lundahl, Scott, Guttadauro, Michael
• Primary Examiner(s): Farah, Ahmed M
• Application Number:
  US15/869,164
• Publication Number:
  US 20190216927A1
• Time in Patent Office: 557 Days
• Field of Search: 607 88, 607 89, 607 96, 607100, 128898
• CPC Class Codes: A61K 31/75 of ethene
• CPC Class Codes: A61K 41/0061 5-aminolevulinic acid-based PDT: 5-ALA-PDT involving porphyrins or precursors of protoporphyrins generated in vivo from 5-ALA
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61N 2005/0633 Arrangements for lifting or hinging the frame which supports the light sources
• CPC Class Codes: A61N 2005/0642 Irradiating part of the body at a certain distance
• CPC Class Codes: A61N 2005/0652 Arrays of diodes
• CPC Class Codes: A61N 2005/0659 infrared
• CPC Class Codes: A61N 2005/0663 Coloured light
• CPC Class Codes: A61N 5/062 Photodynamic therapy, i.e. excitation of an agent
• CPC Class Codes: A61P 17/12 Keratolytics, e.g. wart or anti-corn preparations

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.

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 minimize transepidermal water loss from the treatment area; and

removing the low density polyethylene barrier within 3 hours and then applying light to the treatment area.

2. A method as set forth in claim 1, wherein the low density polyethylene barrier is removed from the treatment area within 3 hours and then blue light is applied to the treatment area for a 10 J/cm² light dose.

3. The method of claim 1, wherein a maximum plasma concentration of ALA following application of the ALA is less than about 110 ng/mL.

4. 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; and

after the ALA is applied to the treatment area, covering the treatment area with a low density polyethylene barrier prior to light treatment to minimize transepidermal water loss from the treatment area,

wherein the treatment area is located on a hand or a forearm.

5. A method as set forth in claim 4, wherein the low density polyethylene barrier is removed from the treatment area and then red light is applied to the treatment area for a 10 to 75 J/cm² light dose.

6. The method as set forth in claim 4, wherein the treatment area is a dorsal surface of the hand.

7. The method as set forth in claim 4, wherein the treatment area is a dorsal surface of the forearm.

8. A method of using 5-aminolevulinic acid (ALA) and a low density polyethylene barrier, comprising:

contacting a treatment site with a composition comprising the ALA so as to wet the treatment site;

following wetting of the treatment site, covering the wetted treatment site with the low density polyethylene barrier;

removing the low density polyethylene barrier so as to expose the treatment site; and

illuminating the exposed treatment site with an illuminator so as to deliver a 10 J/cm² dose of blue light.

9. The method of claim 8, wherein the low density polyethylene barrier is removed no later than three hours after the treatment site is covered.

10. The method of claim 8, further comprising:

positioning the treatment site between two inches and four inches from a surface of the illuminator.