Claims for Patent: 11,426,378

Summary for Patent: 11,426,378

Title:	Method for long-term treatment of rosacea
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%.
Inventor(s):	Ofer Toledano, Ofra Levy-Hacham, Ori NOV, Vered RAM
Assignee:	Mayne Pharma LLC
Application Number:	US16/794,887
Patent Claims:	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.