Method for treatment of rosacea in patients aged 65 years and older

Patent metadata

Field	Value
Publication number	US-11865100-B2
Application number	US-202117154689-A
Country	US
Kind code	B2
Filing date	Jan 21, 2021
Priority date	Feb 19, 2019
Publication date	Jan 9, 2024
Grant date	Jan 9, 2024

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.

First claim

What is claimed is:

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.

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 benzoyl peroxide is the sole active ingredient administered to the subject during the duration of the regimen.

10. The regimen of claim 1 , wherein the pharmaceutical composition comprises about 5% w/w of benzoyl peroxide.

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

12. 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.

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

14. The regimen of claim 1 , wherein said pharmaceutical composition is an extended release formulation, wherein the extended-release effect is obtained by encapsulation, microencapsulation, microspheres or coating.

15. 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.

16. The pharmaceutical composition of claim 15 , wherein said pharmaceutical composition comprises about 5.0% w/w benzoyl peroxide.

17. 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.

18. The regimen of claim 17 , 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.

19. The regimen of claim 17 , 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.

20. The regimen of claim 17 , 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.

21. The regimen of claim 17 , wherein the benzoyl peroxide is the sole active ingredient administered to the subject during the duration of the regimen.

22. The regimen of claim 17 , wherein the pharmaceutical composition comprises about 5% w/w of benzoyl peroxide.

23. The regimen of claim 17 , wherein the benzoyl peroxide is in a form selected from solid, solution or suspension.

24. The regimen of claim 17 , 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.

25. The regimen of claim 17 , wherein said pharmaceutical composition is a cream or an emulsion.

26. The regimen of claim 17 , wherein said pharmaceutical composition is an extended release formul

Assignees

• Sol Gel Tech Ltd

Inventors

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

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