Method for treatment of rosacea

Patent metadata

Field	Value
Publication number	US-11986456-B2
Application number	US-202218076444-A
Country	US
Kind code	B2
Filing date	Dec 7, 2022
Priority date	Feb 19, 2019
Publication date	May 21, 2024
Grant date	May 21, 2024

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.

First claim

What is claimed is:

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.

2. The treatment regimen of claim 1 , wherein the primary measure of success after at least about 2 weeks of treatment is at least about 9%.

3. The treatment regimen of claim 1 , wherein the primary measure of success after at least about 4 weeks of treatment is at least about 25%.

4. The treatment regimen of claim 1 , wherein the primary measure of success after at least about 8 weeks of treatment is at least about 40%.

5. The treatment regimen of claim 1 , wherein the primary measure of success after about 12 weeks of treatment is at least about 47%.

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

7. The treatment regimen of claim 1 , wherein said pharmaceutical composition comprises about 5% w/w of benzoyl peroxide.

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

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

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

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

13. The treatment regimen of claim 1 , wherein the benzoyl peroxide is encapsulated or microencapsulated within the core of a microcapsule comprising a metal oxide shell or semi-metal oxide shell.

14. The treatment regimen of claim 1 , wherein said pharmaceutical composition comprises about 3% w/w to about 5% w/w of benzoyl peroxide.

15. The treatment regimen of claim 1 , wherein said pharmaceutical composition is an emulsion.

16. The treatment regimen of claim 11 , wherein the rosacea is erythematotelangiectatic rosacea.

17. The treatment regimen of claim 11 , wherein the rosacea is papulopustular rosacea.

18. The treatment regimen of claim 11 , wherein the rosacea is phymatous rosacea.

19. The treatment regimen of claim 11 , wherein the rosacea is ocular rosacea.

Assignees

• Sol Gel Tech Ltd

Inventors

• Arkin Moshe
• Neimann Karine
• Toledano Ofer

Classifications

• A61K31/327 Primary

  Peroxy compounds, e.g. hydroperoxides, peroxides, peroxyacids · CPC title

• A61K9/0014

  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 title

• A61K9/06

  Ointments; Bases therefor; {Other semi-solid forms, e.g. creams, sticks, gels (composition of ointments, creams or gels A61K47/00)} · CPC title

• A61K9/10

  Dispersions; Emulsions · CPC title

• A61K9/107

  Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)} · CPC title