IP Library Granted Patent US 11,541,026
Granted Patent B2
US 11,541,026 · App. 17/541,847 · Granted Jan 3, 2023

Method for treatment of rosacea

Inventors: Moshe Arkin (Kfar Shmaryahu, IL); Karine Neimann (Ness Ziona, IL); Ofer Toledano (Kfar Saba, IL)
Assignee: SOL-GEL TECHNOLOGIES LTD.
A61K31/327A61K9/0014A61K9/06A61K9/10A61K9/107A61K9/50A61P17/00A61P17/10
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Quick Facts
Patent No.
US 11,541,026
App. No.
17/541,847
Granted
Jan 3, 2023
Kind
B2
Abstract

A regimen is described for the therapeutic treatment of rosacea. The regimen includes topically applying a pharmaceutical composition to the skin of a subject in need of said treatment. The pharmaceutical composition includes from about 2.5% to about 10% benzoyl peroxide as the only active ingredient, and a pharmaceutically acceptable carrier or excipient. The regimen achieves, 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.

Claims (15)

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 secondary measure of success from of at least about 40%, at least about 55%, at least about 65%, or at least about 69%, after application of said pharmaceutical composition once daily for a period of 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 secondary measure of success is defined as a percentage decrease in the number of inflammatory lesions,

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.

2. The first-line treatment regimen of claim 1 , wherein the secondary measure of success after at least about 2 weeks of treatment is at least about 40%.

3. The first-line treatment regimen of claim 1 , wherein the secondary measure of success after at least about 4 weeks of treatment is at least about 55%.

4. The first-line treatment regimen of claim 1 , wherein the secondary measure of success after at least about 8 weeks of treatment is at least about 65%.

5. The first-line treatment regimen of claim 1 , wherein the secondary measure of success after about 12 weeks of treatment is at least about 69%.

6. The first-line treatment regimen of claim 1 , wherein said pharmaceutical composition is a cream.

7. The first-line treatment regimen of claim 1 , wherein said pharmaceutical composition comprises about 5% of benzoyl peroxide.

8. The first-line treatment regimen of claim 1 , wherein said benzoyl peroxide is in a form selected from solid, solution or suspension.

9. The first-line treatment regimen of claim 1 , wherein the rosacea is any of erythematotelangiectatic, papulopustular, phymatous or ocular rosacea.

10. The first-line treatment regimen of claim 1 , wherein said pharmaceutical composition is an extended-release formulation.

11. The first-line treatment regimen of claim 1 , wherein said regimen has an adverse events value similar to or lower than the adverse events value of a vehicle control.

12. The first-line treatment regimen of claim 1 , wherein the pharmaceutical composition is physically and chemically stable for a period of at least about 12 weeks.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 18, 2025
From: SOL-GEL TECHNOLOGIES LTD.
To: MAYNE PHARMA LLC
Reel/Frame 071148/0446 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 16, 2021
From: TOLEDANO, OFER; ARKIN, MOSHE; NEIMANN, KARINE
To: SOL-GEL TECHNOLOGIES LTD.
Reel/Frame 058402/0980 →
Continuity (13)
Continuation 17156941 · Jan 25, 2021
Continuation 16794734 · Feb 19, 2020
Provisional Application 62977974 · Feb 18, 2020
Provisional Application 62972896 · Feb 11, 2020
Provisional Application 62972310 · Feb 10, 2020
Provisional Application 62960384 · Jan 13, 2020
Provisional Application 62925258 · Oct 24, 2019
Provisional Application 62871283 · Jul 8, 2019
Provisional Application 62871286 · Jul 8, 2019
Provisional Application 62807368 · Feb 19, 2019
Provisional Application 62807356 · Feb 19, 2019
Provisional Application 62977952 · Feb 18, 2020
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