Method for long-term treatment of rosacea

Patent metadata

Field	Value
Publication number	US-11426378-B2
Application number	US-202016794887-A
Country	US
Kind code	B2
Filing date	Feb 19, 2020
Priority date	Feb 19, 2019
Publication date	Aug 30, 2022
Grant date	Aug 30, 2022

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%.

First claim

What is claimed is:

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.

Assignees

• Sol Gel Tech Ltd

Inventors

• Toledano Ofer
• Levy-Hacham Ofra
• Nov Ori
• Ram Vered

Classifications

• A61P17/10 Primary

  Anti-acne agents · 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

• A61K9/107

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

• A61Q19/00

  Preparations for care of the skin · CPC title

• A61P17/00

  Drugs for dermatological disorders · CPC title