Method for providing early onset of action in the treatment of rosacea

Patent metadata

Field	Value
Publication number	US-11877997-B2
Application number	US-202117156941-A
Country	US
Kind code	B2
Filing date	Jan 25, 2021
Priority date	Feb 19, 2019
Publication date	Jan 23, 2024
Grant date	Jan 23, 2024

Abstract

A regimen is described for providing early onset of action in the therapeutic treatment of rosacea including topically applying a pharmaceutical composition to the skin of a subject in need of said treatment. The pharmaceutical composition includes about 1% to about 10% benzoyl peroxide as the only active ingredient, and a pharmaceutically acceptable carrier or excipient. The pharmaceutical composition is applied once daily for a period of at least about 2, 4, 8 or 12 weeks. Based on early onset of action, a primary measure of success is at least about 9%, primary measure of success being defined as a 2-grade improvement in IGA of clear or almost clear; and a secondary measure of success is at least about 40%, secondary measure of success being defined as mean inflammatory lesion count percent reduction from baseline, after at least about 2 weeks of treatment.

First claim

What is claimed is:

1. A treatment regimen for providing early onset of action in 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 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, 4, 8 or 12 weeks, wherein said pharmaceutical composition comprises a fatty phase and/or an oily phase, wherein a primary measure of success in a group of subjects is at least about 9% after about 2 weeks, and wherein the primary measure of success is defined as a 2-grade improvement in Investigator Global Assessment (IGA) and clear or almost clear.

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

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

4. The treatment regimen of claim 1 , wherein the benzoyl peroxide is the sole active ingredient administered to the subject in need of said treatment during the duration of the regimen.

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

6. The treatment regimen of claim 1 , wherein the regimen is a first-line therapy for the treatment of rosacea.

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

8. The treatment regimen of claim 1 , wherein said pharmaceutical composition is an extended release formulation, and the benzoyl peroxide is encapsulated, microencapsulated, included in a microsphere and/or included in a coating.

9. A treatment regimen for providing early onset of action in 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 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, 4, 8 or 12 weeks, wherein said pharmaceutical composition comprises a fatty phase and/or an oily phase, wherein a primary measure of success in a group of subjects is at least about 9% to about 40%, wherein the primary measure of success is defined as a 2-grade improvement in Investigator Global Assessment (IGA) and clear or almost clear, and wherein said regimen has an adverse events values similar to or lower than the adverse events values of a vehicle control.

10. A treatment regimen for providing early onset of action in 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 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, 4, 8 or 12 weeks, wherein said pharmaceutical composition comprises a fatty phase and/or an oily phase, wherein a secondary measure of success in a group of such subjects is at least about 40% after at least about 2 weeks, and wherein the secondary measure of success is defined as mean inflammatory lesion count percent reduction from baseline.

11. The treatment regimen of claim 10 , wherein the secondary measure of success is at least about 55% after at least about 4 weeks.

12. The treatment regimen of claim 10 , wherein the secondary measure of success is at least about 65% after at least about 8 weeks.

13. The treatment regimen of claim 10 , wherein the benzoyl peroxide is the sole active ingredient administered to the subject in need of said treatment during the duration of the regimen.

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

15. The treatment regimen of claim 10 , wherein the regimen is a first-line therapy for the treatment of rosacea.

16. The treatment regimen of claim 10 , wherein the rosacea is any of erythematotelengietatic, papulopustular, phymatous or ocular rosacea.

17. The treatment regimen of claim 10 , wherein said pharmaceutical composition is an extended release formulation, and wherein the benzoyl peroxide is encapsulated, microencapsulated, included in a microsphere and/or included in a coating.

18. A treatment regimen for providing early onset of action in 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 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, 4, 8 or 12 weeks, wherein said pharmaceutical composition comprises a fatty phase and/or an oily phase, wherein a secondary measure of success in a group of such subjects is at least about 40% to at least about 65%, wherein the second measure of success is defined as mean inflammatory lesion count percent reduction from baseline, and wherein said regimen has an adverse events values similar to or lower than the adverse events values of a vehicle control.

19. A treatment regimen for providing early onset of action in 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 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 comprises a fatty phase and/or an oily phase, wherein said pharmaceutical composition is applied once daily for a period of at least about 2, 4, 8 or 12 weeks, wherein the absolute reduction in lesion count after about 2 weeks is at least twice the absolute reduction in lesion count after about 4 weeks of treatment, wherein a secondary measure of success in the group of subjects is at least about 40% to at least about 65%, and wherein the secondary measure of success is defined as mean inflammatory lesion count percent reduction from baseline.

20. The treatment regimen of claim 19 , wherein the benzoyl peroxide is the sole active ingredient administered to the subject in need of said treatment during the duration of the treatment regimen.

21. The treatment regimen of claim 19 , wherein the pharmaceutical composition comprises about 5% w/w of benzoyl peroxide.

22. The treatment regimen of claim 19 , wherein the r

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