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

Patent metadata

Field	Value
Publication number	US-10945987-B2
Application number	US-202016794734-A
Country	US
Kind code	B2
Filing date	Feb 19, 2020
Priority date	Feb 19, 2019
Publication date	Mar 16, 2021
Grant date	Mar 16, 2021

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 is a cream or an emulsion, wherein a primary measure of success in a group of subjects is at least about 9% to about 40%, and wherein the primary measure of success is defined as a 2-grade improvement in Investigator Global Assessment (IGA) and clear or almost clear, wherein the primary measure of success is at least about 9% after about 2 weeks,
wherein the benzoyl peroxide is the sole active ingredient administered to the subject in need of said treatment during the duration of the regimen,
wherein the benzoyl peroxide is encapsulated and/or microencapsulated, and
wherein the treatment regimen provides early onset of action in the therapeutic treatment of rosacea.

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 pharmaceutical composition comprises about 5% w/w of benzoyl peroxide.

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

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

7. The treatment regimen of claim 1 , wherein said pharmaceutical composition is an extended release formulation.

8. The treatment regimen of claim 1 , wherein said regimen has adverse events values similar to or lower than the adverse events values of a vehicle control.

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 is a cream or an emulsion, wherein a secondary measure of success in a group of such 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, wherein the secondary measure of success is at least about 40% after at least about 2 weeks,
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,
wherein the benzoyl peroxide is encapsulated and/or microencapsulated, and
wherein the treatment regimen provides early onset of action in the therapeutic treatment of rosacea.

10. The treatment regimen of claim 9 , wherein the secondary measure of success is at least about 55% after at least about 4 weeks.

11. The treatment regimen of claim 9 , wherein the secondary measure of success is at least about 65% after at least about 8 weeks.

12. The treatment regimen of claim 9 , wherein the pharmaceutical composition comprises about 5% w/w of benzoyl peroxide.

13. The treatment regimen of claim 9 , wherein the regimen is a first-line therapy for the treatment of rosacea.

14. The treatment regimen of claim 9 , wherein the rosacea is any of erythematotelengietatic, papulopustular, phymatous or ocular rosacea.

15. The treatment regimen of claim 9 , wherein said pharmaceutical composition is an extended release formulation.

16. The treatment regimen of claim 9 , wherein said regimen has adverse events values similar to or lower than the adverse events values of a vehicle control.

17. 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 a cream or an emulsion, wherein said pharmaceutical composition is applied once daily for a period of at least about 2, 4, 8 or 12 weeks, and 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 the benzoyl peroxide is the sole active ingredient administered to the subject in need of said treatment during the duration of the treatment regimen,
wherein the benzoyl peroxide is encapsulated and/or microencapsulated, and
wherein the treatment regimen provides early onset of action in the therapeutic treatment of rosacea.

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

19. The treatment regimen of claim 17 , wherein the regimen is a first line therapy for the treatment of rosacea.

20. The treatment regimen of claim 17 , wherein the rosacea is any of erythematotelengietatic, papulopustular, phymatous or ocular rosacea.

21. The treatment regimen of claim 17 , wherein said pharmaceutical composition is an extended release formulation.

22. The treatment regimen of claim 17 , wherein said regimen has an adverse events values similar to or lower than the adverse events values of a vehicle control.

23. The treatment regimen of claim 17 , wherein a primary measure of success in the group of subjects is at least about 9% to about 40%, and wherein the primary measure of success is defined as a 2-grade improvement in Investigator Global Assessment (IGA) and clear or almost clear.

24. The treatment regimen of claim 17 , 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.

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

• A61K9/50

  Microcapsules {having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals (A61K9/2081 takes precedence; particles with a single coating comprising drug A61K9/167)} · CPC title

• A61P17/10 Primary

  Anti-acne agents · CPC title

• A61P17/00

  Drugs for dermatological disorders · CPC title

• A61Q19/00

  Preparations for care of the skin · CPC title