US 11,986,456 B2
Method for treatment of rosacea
Moshe Arkin, Kfar Shmaryahu (IL); Karine Neimann, Ness Ziona (IL); and Ofer Toledano, Kfar Saba (IL)
Assigned to Sol-Gel Technologies Ltd., Ness Ziona (IL)
Filed by Sol-Gel Technologies Ltd., Ness Ziona (IL)
Filed on Dec. 7, 2022, as Appl. No. 18/076,444.
Application 18/076,444 is a continuation of application No. 17/541,847, filed on Dec. 3, 2021, granted, now 11,541,026.
Application 17/541,847 is a continuation of application No. 17/156,941, filed on Jan. 25, 2021, granted, now 11,877,997.
Application 17/156,941 is a continuation of application No. 16/794,734, filed on Feb. 19, 2020, granted, now 10,945,987, issued on Mar. 16, 2021.
Claims priority of provisional application 62/977,974, filed on Feb. 18, 2020.
Claims priority of provisional application 62/977,952, filed on Feb. 18, 2020.
Claims priority of provisional application 62/972,896, filed on Feb. 11, 2020.
Claims priority of provisional application 62/972,310, filed on Feb. 10, 2020.
Claims priority of provisional application 62/960,384, filed on Jan. 13, 2020.
Claims priority of provisional application 62/925,258, filed on Oct. 24, 2019.
Claims priority of provisional application 62/871,283, filed on Jul. 8, 2019.
Claims priority of provisional application 62/871,286, filed on Jul. 8, 2019.
Claims priority of provisional application 62/807,368, filed on Feb. 19, 2019.
Claims priority of provisional application 62/807,356, filed on Feb. 19, 2019.
Prior Publication US 2023/0106220 A1, Apr. 6, 2023
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/327 (2006.01); A61K 9/00 (2006.01); A61K 9/06 (2006.01); A61K 9/10 (2006.01); A61K 9/107 (2006.01); A61K 9/50 (2006.01); A61P 17/00 (2006.01); A61P 17/10 (2006.01)
CPC A61K 31/327 (2013.01) [A61K 9/0014 (2013.01); A61K 9/06 (2013.01); A61K 9/10 (2013.01); A61K 9/107 (2013.01); A61K 9/50 (2013.01); A61P 17/00 (2018.01); A61P 17/10 (2018.01)] 19 Claims
 
1. A treatment regimen for the therapeutic treatment of rosacea, the regimen comprising topically applying to the skin of a subject in need of said treatment, a pharmaceutical composition, the pharmaceutical composition comprising from about 2.5% to about 10% benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient, to achieve, in a group of such subjects, a primary measure of success of at least about 9%, at least about 25%, at least about 40%, or at least about 47%, after application of said pharmaceutical composition once daily for at least about 2 weeks, at least about 4 weeks, at least about 8 weeks, or at least about 12 weeks, respectively, wherein the benzoyl peroxide is the only active ingredient in said pharmaceutical composition, wherein said pharmaceutical composition is a cream or an emulsion, and wherein the primary measure of success is defined as a 2-grade improvement in Investigator Global Assessment (IGA) and clear or almost clear,
wherein the regimen is a first-line therapy for the treatment of rosacea,
wherein the benzoyl peroxide is the sole active ingredient administered to the subject in need of said treatment during the duration of the regimen, and
wherein the benzoyl peroxide is encapsulated and/or microencapsulated.