Claims for Patent: 10,933,046

Summary for Patent: 10,933,046

Title:	Method for treatment of rosacea in patients aged 65 years and older
Abstract:	A regimen for the therapeutic treatment of rosacea in subjects aged 65 years and older, the regimen comprising topically applying to the skin of a subject aged 65 years and older 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 at least about 2 weeks, to achieve, in a group of such subjects, a success rate of at least about 15%, wherein the success rate is defined as the number of subjects achieving clear or almost clear skin on the investor global assessment (IGA) scale after treatment with the pharmaceutical composition.
Inventor(s):	Toledano; Ofer (Kfar Saba, IL), Levy-Hacham; Ofra (Ness Ziona, IL), Nov; Ori (Tarum, IL), Ram; Vered (Rehovot, IL)
Assignee:	SOL-GEL TECHNOLOGIES, LTD. (Ness Ziona, IL)
Application Number:	16/794,839
Patent Claims:	1. A regimen for the therapeutic treatment of rosacea in subjects aged 65 years and older, the regimen comprising topically applying to the skin of a subject aged 65 years and older in need of said treatment a pharmaceutical composition, the pharmaceutical composition comprising about 2.5% 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 at least about 2 weeks, to achieve, in a group of such subjects, a success rate of at least about 15%, wherein the success rate is defined as the number of subjects achieving clear or almost clear skin on the investor global assessment (IGA) scale after treatment with the pharmaceutical composition, wherein the benzoyl peroxide is the sole active ingredient administered to the subject during the duration of the regimen, and wherein the benzoyl peroxide is encapsulated or microencapsulated. 2. The regimen of claim 1, wherein the success rate of said regimen is at least about 10% greater than a success rate achieved by a vehicle control. 3. The regimen of claim 1, wherein said pharmaceutical composition is applied once daily for a period of at least about 4 weeks, to achieve, in a group of such subjects, a success rate of at least about 25%, wherein the success rate is defined as the number of subjects achieving clear or almost clear skin on the investor global assessment (IGA) scale after treatment with the pharmaceutical composition. 4. The regimen of claim 3, wherein the success rate of said regimen is at least about 2% greater than a success rate achieved by a vehicle control. 5. The regimen of claim 1, wherein said pharmaceutical composition is applied once daily for a period of at least about 8 weeks, to achieve, in a group of such subjects, a success rate of at least about 45%, wherein the success rate is defined as the number of subjects achieving clear or almost clear skin on the investor global assessment (IGA) scale after treatment with the pharmaceutical composition. 6. The regimen of claim 5, wherein the success rate of said regimen is at least about 27% greater than a success rate achieved by the vehicle control. 7. The regimen of claim 1, wherein said pharmaceutical composition is applied once daily for a period of at least about 12 weeks, to achieve, in a group of such subjects, a success rate of at least about 50%, wherein the success rate is defined as the number of subjects achieving clear or almost clear skin on the investor global assessment (IGA) scale after treatment with the pharmaceutical composition. 8. The regimen of claim 7, wherein the success rate of said regimen is at least about 28% greater than the success rate achieved by the vehicle control. 9. The regimen of claim 1, wherein the pharmaceutical composition comprises about 5% w/w of benzoyl peroxide. 10. The regimen of claim 1, wherein the regimen is a first line therapy for the treatment of rosacea, wherein the rosacea is any of erythematotelengietatic, papulopustular, phymatous or ocular rosacea. 11. The regimen of claim 1, wherein said pharmaceutical composition is a cream or an emulsion. 12. The regimen of claim 1, wherein said pharmaceutical composition is an extended release formulation. 13. A pharmaceutical composition for use in the treatment of severe rosacea in a subject aged 65 years and older, said pharmaceutical composition comprising from about 2.5% 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, and said pharmaceutical composition is applied once daily for a period of at least about 2 weeks, 4 weeks, 8 weeks or 12 weeks, to achieve, in a group of such subjects, a success rate of at least about 15%, about 25%, about 45%, about 50%, respectively, wherein the success rate is defined as the number of subjects achieving clear or almost clear skin on the investor global assessment (IGA) scale after treatment with the pharmaceutical composition, wherein the benzoyl peroxide is the sole active ingredient administered to the subject during the duration of the regimen, and wherein the benzoyl peroxide is encapsulated or microencapsulated. 14. The pharmaceutical composition of claim 13, wherein said pharmaceutical composition comprises about 5.0% w/w benzoyl peroxide. 15. A regimen for the therapeutic treatment of rosacea in a subject aged 65 years and older, the regimen comprising topically applying to the skin of the subject aged 65 years and older in need of said treatment a pharmaceutical composition, the pharmaceutical composition comprising about 2.5% 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 at least about 2 weeks, to achieve, in a group of such subjects, a mean percentage decrease, from baseline, in the number of inflammatory lesions of about 40% compared to a mean percentage decrease, from baseline, in the inflammatory lesions of about 25% after treatment with vehicle control, wherein the benzoyl peroxide is the sole active ingredient administered to the subject during the duration of the regimen, and wherein the benzoyl peroxide is encapsulated or microencapsulated. 16. The regimen of claim 15, wherein said pharmaceutical composition is applied once daily for a period of at least about 4 weeks, to achieve, in a group of such subjects, a mean percentage decrease, from baseline, in the number of inflammatory lesions of about 55% compared to a mean percentage decrease, from baseline, in the inflammatory lesions of about 35% after treatment with vehicle control. 17. The regimen of claim 15, wherein said pharmaceutical composition is applied once daily for a period of at least about 8 weeks, to achieve, in a group of such subjects, a mean percentage decrease, from baseline, in the number of inflammatory lesions of about 60% compared to a mean percentage decrease, from baseline, in the inflammatory lesions of about 35% after treatment with vehicle control. 18. The regimen of claim 15, wherein said pharmaceutical composition is applied once daily for a period of at least about 12 weeks, to achieve, in a group of such subjects, a mean percentage decrease, from baseline, in the number of inflammatory lesions of about 65% compared to a mean percentage decrease, from baseline, in the inflammatory lesions of about 35% after treatment with vehicle control. 19. The regimen of claim 15, wherein the pharmaceutical composition comprises about 5% w/w of benzoyl peroxide. 20. The regimen of claim 15, wherein the regimen is a first line therapy for the treatment of rosacea, wherein the rosacea is any of erythematotelengietatic, papulopustular, phymatous or ocular rosacea. 21. The regimen of claim 15, wherein said pharmaceutical composition is a cream or an emulsion. 22. The regimen of claim 15, wherein said pharmaceutical composition is an extended release formulation. 23. A pharmaceutical composition for use in the treatment of severe rosacea in subjects aged 65 years and older, said pharmaceutical composition comprising from about 2.5% 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, and said pharmaceutical composition is applied once daily to a group of subjects aged 65 years and older for a period of at least about 2 weeks, about 4 weeks, about 8 weeks or about 12 weeks, to achieve, in a group of such subjects aged 65 years and older, a mean percentage decrease, from baseline, in the number of inflammatory lesions of about 40%, about 55%, about 60% or about 65%, respectively, compared to a mean percentage decrease, from baseline, in the inflammatory lesions of about 25%, about 35%, about 35% or about 35%, respectively, after treatment with vehicle control, wherein the benzoyl peroxide is the sole active ingredient administered to the subject during the duration of the regimen, and wherein the benzoyl peroxide is encapsulated or microencapsulated. 24. The pharmaceutical composition of claim 23, wherein the mean percentage decrease, from baseline, in the number of inflammatory lesions after treatment for a period of at least about 2 weeks, about 4 weeks, about 8 weeks or about 12 weeks is about 45%, about 60%, about 69% or about 70%, respectively, compared to a mean percentage decrease, from baseline, in the inflammatory lesions of about 29%, about 42%, about 41% or about 41%, respectively, after treatment with vehicle control. 25. The pharmaceutical composition of claim 23, wherein said pharmaceutical composition comprises about 5.0% w/w benzoyl peroxide.