IP Library Granted Patent US 11,426,378
Granted Patent B2
US 11,426,378 · App. 16/794,887 · Granted Aug 30, 2022

Method for long-term treatment of rosacea

Inventors: Ofer Toledano (Kfar Saba, IL); Ofra Levy-Hacham (Ness Ziona, IL); Ori Nov (Tarum, IL); Vered Ram (Rehovot, IL)
Assignee: SOL-GEL TECHNOLOGIES LTD.
A61K31/327A61K9/0014A61K9/06A61K9/10A61K9/107A61K9/50A61P17/00A61P17/10
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Quick Facts
Patent No.
US 11,426,378
App. No.
16/794,887
Granted
Aug 30, 2022
Kind
B2
Abstract

A regimen for the long-term therapeutic treatment of rosacea. The regimen includes topically applying a pharmaceutical composition to the skin of a subject. The pharmaceutical composition includes about 1% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient. The benzoyl peroxide is the only active ingredient in the pharmaceutical composition, and the pharmaceutical composition is applied once daily for a period of about 52 weeks, to achieve, in a group of such subjects, a success rate of about 75%.

Claims (16)

1. A regimen for the long-term 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 about 1% w/w to about 10% w/w benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient, wherein the benzoyl peroxide is the only active ingredient in said pharmaceutical composition, wherein said pharmaceutical composition is applied once daily for a period of about 52 weeks, to achieve, in a group of such subjects, a success rate of about 75%, wherein the success rate is defined as a percentage of the number of subjects achieving clear or almost clear skin on the investor global assessment (IGA) scale after treatment with the pharmaceutical composition.

2. The regimen of claim 1 , wherein the benzoyl peroxide is the sole active ingredient administered to the subject during the duration of the regimen.

3. The regimen of claim 1 , wherein the pharmaceutical composition comprises about 2.5% w/w to about 10% w/w of benzoyl peroxide.

4. The regimen of claim 3 , wherein the pharmaceutical composition comprises about 5% w/w of benzoyl peroxide.

5. The regimen of claim 1 , wherein the benzoyl peroxide is selected from a solid, solution or suspension form.

6. The regimen of claim 1 , wherein the regimen is a first line therapy for the treatment of rosacea.

7. The regimen of claim 1 , wherein the rosacea is any of erythematotelengietatic rosacea, papulopustular rosacea, phymatous rosacea or ocular rosacea.

8. The regimen of claim 1 , wherein said pharmaceutical composition is a cream or an emulsion.

9. The regimen of claim 1 , wherein said pharmaceutical composition is an extended release formulation.

10. The regimen of claim 9 , wherein the extended-release effect is obtained by encapsulation, microencapsulation, microspheres or coating.

11. The regimen of claim 10 , wherein the benzoyl peroxide is encapsulated or microencapsulated.

12. The regimen of claim 10 , wherein the benzoyl peroxide is included in a microsphere or a coating.

13. The regimen of claim 1 , wherein the rosacea is moderate to severe rosacea.

14. The regimen of claim 1 , wherein a percentage of subjects having no adverse effects after treatment with the pharmaceutical composition after about 52 weeks is at least 75%.

15. The regimen of claim 14 , where the percentage of subjects having no adverse effects after treatment with the pharmaceutical composition after about 52 weeks is from about 75% to about 85%.

16. The regimen of claim 1 , wherein the adverse effect is selected from itching, burning, dryness, itching and a combination thereof.

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 Feb 27, 2020
From: LEVY-HACHAM, OFRA; NOV, ORI; RAM, VERED; TOLEDANO, OFER
To: SOL-GEL TECHNOLOGIES LTD.
Reel/Frame 051948/0372 →
Continuity (11)
Provisional Application 62977952 · Feb 18, 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 62871286 · Jul 8, 2019
Provisional Application 62871283 · Jul 8, 2019
Provisional Application 62807356 · Feb 19, 2019
Provisional Application 62807368 · Feb 19, 2019
Related Publication 20200261400A1 · Aug 20, 2020