IP Library › Granted Patent US 12,667,735
Granted Patent B2
US 12,667,735 · App. 17/621,317 · Granted Jun 30, 2026

Methods for reducing pain during photodynamic therapy of actinic keratosis

Inventor: Edward V. Maytin (Cleveland, OH)
Assignee: Sun Pharmaceutical Industries, Inc.
A61N5/062A61K41/0061A61P29/00A61N2005/0663
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,667,735
App. No.
17/621,317
Granted
Jun 30, 2026
Kind
B2
Abstract

This present invention and its embodiments relates to methods for reducing pain during photodynamic therapy of actinic keratosis. The present invention also relates to methods of treating actinic keratosis with reduced pain during photodynamic therapy of actinic keratosis.

Claims (23)

1 . A method of reducing pain during a photodynamic therapy of actinic keratoses comprising:

(a) applying a pharmaceutical composition comprising 20% w/v solution of 5-aminolevulinic acid on an affected area of skin of a patient;

(b) illuminating the affected area with a blue light source applied at an intensity of 10 mW/cm 2 with a pre-illumination gap of no more than 10 minutes; and

(c) maintaining the illumination for at least 45 minutes;

wherein the method does not include a pre-treatment preparation.

2 . The method according to claim 1 , wherein the blue light source delivers a light having a wavelength of 417 nm±5 nm.

3 . The method according to claim 1 , wherein the actinic keratoses is of face and/or scalp.

4 . The method according to claim 1 , wherein the illumination of step (c) is carried out for at least 60 minutes.

5 . The method according to claim 1 , wherein the method results in a significantly reduced VAS pain score as compared to a photodynamic therapy with a pre-illumination gap of at least 60 minutes.

6 . The method according to claim 5 , wherein the resulting VAS pain score is less than 1.0.

7 . The method according to claim 5 , wherein the resulting VAS pain score is 0.5+0.5.

8 . The method according to claim 5 , wherein the resulting VAS pain score is 0.0.

9 . A method of treating actinic keratoses comprising:

(a) applying a pharmaceutical composition comprising 20% w/v solution of 5-aminolevulinic acid on an affected area of skin of a patient;

(b) illuminating the affected area with a blue light source applied at an intensity of 10 mW/cm 2 with a pre-illumination gap of no more than 10 minutes; and

(c) maintaining the illumination for at least 45 minutes;

wherein the method does not include a pre-treatment preparation.

10 . The method according to claim 9 , wherein the blue light source delivers a light having a wavelength of 417 nm±5 nm.

11 . The method according to claim 9 , wherein the illumination of step (c) is carried out for at least 60 minutes.

12 . The method according to claim 9 , wherein the method results in a significantly reduced VAS pain score as compared to a photodynamic therapy with a pre-illumination gap of at least 60 minutes.

13 . The method according to claim 12 , wherein the resulting VAS pain score is less than 1.0.

14 . The method according to claim 12 , wherein the resulting VAS pain score is 0.5±0.5.

15 . The method according to claim 12 , wherein the resulting VAS pain score is 0.0.

Assignments (3)
MERGER Recorded May 30, 2024
From: DUSA PHARMACEUTICALS, INC.
To: SUN PHARMACEUTICAL INDUSTRIES, INC.
Reel/Frame 067565/0986 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 22, 2022
From: THE CLEVELAND CLINIC FOUNDATION
To: DUSA PHARMACEUTICALS, INC.
Reel/Frame 060595/0596 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 21, 2022
From: MAYTIN, EDWARD V.
To: THE CLEVELAND CLINIC FOUNDATION
Reel/Frame 060575/0528 →
Continuity (2)
Provisional Application 62866311 · Jun 25, 2019
Related Publication 20220362573A1 · Nov 17, 2022
References Cited (22)
US 20100137439A1 · Wulf · 2010 [cited by examiner]
US 20100174223A1 · Sakamoto et al. · 2010 [cited by applicant]
US 20110082410A1 · Volker et al. · 2011 [cited by applicant]
US 20140067024A1 · Jones · 2014 [cited by examiner]
US 20160030565A1 · Wulf et al. · 2016 [cited by applicant]
US 20160367832A1 · Jones et al. · 2016 [cited by applicant]
JP 2005520606A · 2005 [cited by applicant]
JP 2010515714A · 2010 [cited by applicant]
JP 2017505292A · 2017 [cited by applicant]
WO WO2008052350A1 · 2008 [cited by applicant]
WO WO2008084241A2 · 2008 [cited by applicant]
Gandy, J. et al., “Photodynamic Therapy Effectively Treats Actinic Keratoses Without Pre-Illumination Incubation Time”; J. Drugs Dermatol 16(3); Mar. 2017; pp. 275-278. [cited by applicant]
Anand et al., Biomodulatory Approaches to Photodynamic Therapy for Solid Turmors, Cancer Letters, 326, 2012, pp. 8-16. [cited by applicant]
Ang et al., Photodynamic Therapy and Pain: A Systematic Review, Photodiagnosis and Photodynamic Therapy, vol. 19, Jul. 15, 2017, pp. 308-344. [cited by applicant]
Braathen et al., Guidelines on the Use of Photodynamic Therapy for Nonmelanoma Skin Cancer: An International Consensus, The American Academy of Dermatology, Inc. 2007, pp. 125-143. [cited by applicant]
Christensen et al., Guidelines for Practical Use of MAL-PDT in Non-Melanoma Skin Cancer, JEADV, 2010, 24, pp. 505-512. [cited by applicant]
Harald Breivik, Fifty Years on the Visual Analogue Scale (VAS) for Pain-Intensity is Still Good for Acute Pain. But Multidimensional Assessment is Needed for Chronic Pain, Scandinavian Journal of Pain, 2016, pp. 150-152. [cited by applicant]
Kennedy et al., Endogenous Protoporphyrin IX, A Clinically Useful Photosensitizer for Photodynamic Therapy, J. Photochem. Photobiol. B: Biol., 14, 1992, pp. 275-292. [cited by applicant]
Pariser et al., Randomized Vehicle-Controlled Study of Short Drug Incubation Aminolevulinic Acid Photodynamic Therapy for Actinic Keratoses of the Face or Scalp, American Society for Dermatologic Surgery, Inc., 2016, pp… [cited by applicant]
Piacquadio et al., Photodynamic Therapy With Aminolevulinic Acid Topical Solution and Visible Blue Light in the Treatment of Multiple Actinic Keratoses of the Face and Scalp, Arch Dermatol, vol. 140, Jan. 2004, pp. 41-4… [cited by applicant]
Warren et al., Pain Associated with Aminolevulinic Acid-Photodynamic Therapy of Skin Disease, Journal American Academy of Dermatology, Dec. 2009, pp. 1033-1043. [cited by applicant]
Extended European Search Report in EP20831638.0 dated Jun. 1, 2023. [cited by applicant]