Claims for Patent: 11,541,026
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Summary for Patent: 11,541,026
| Title: | Method for treatment of rosacea |
| Abstract: | A regimen is described for the therapeutic treatment of rosacea. The regimen includes topically applying a pharmaceutical composition to the skin of a subject in need of said treatment. The pharmaceutical composition includes from about 2.5% to about 10% benzoyl peroxide as the only active ingredient, and a pharmaceutically acceptable carrier or excipient. The regimen achieves, in a group of such subjects, a primary measure of success of at least about 9%, at least about 25%, at least about 40%, or at least about 47%, after application of said pharmaceutical composition once daily for at least about 2 weeks, at least about 4 weeks, at least about 8 weeks, or at least about 12 weeks, respectively. |
| Inventor(s): | Moshe Arkin, Karine Neimann, Ofer Toledano |
| Assignee: | Sol Gel Technologies Ltd |
| Application Number: | US17/541,847 |
| Patent Claims: |
1. A treatment regimen for 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 from about 2.5% to about 10% benzoyl peroxide as an active ingredient, and a pharmaceutically acceptable carrier or excipient, to achieve, in a group of such subjects, a secondary measure of success from of at least about 40%, at least about 55%, at least about 65%, or at least about 69%, after application of said pharmaceutical composition once daily for a period of at least about 2 weeks, at least about 4 weeks, at least about 8 weeks, or at least about 12 weeks, respectively, wherein the benzoyl peroxide is the only active ingredient in said pharmaceutical composition, wherein said pharmaceutical composition is a cream or an emulsion, and wherein the secondary measure of success is defined as a percentage decrease in the number of inflammatory lesions, wherein the regimen is a first-line therapy for the treatment of rosacea, wherein the benzoyl peroxide is the sole active ingredient administered to the subject in need of said treatment during the duration of the regimen, and wherein the benzoyl peroxide is encapsulated and/or microencapsulated. 2. The first-line treatment regimen of claim 1, wherein the secondary measure of success after at least about 2 weeks of treatment is at least about 40%. 3. The first-line treatment regimen of claim 1, wherein the secondary measure of success after at least about 4 weeks of treatment is at least about 55%. 4. The first-line treatment regimen of claim 1, wherein the secondary measure of success after at least about 8 weeks of treatment is at least about 65%. 5. The first-line treatment regimen of claim 1, wherein the secondary measure of success after about 12 weeks of treatment is at least about 69%. 6. The first-line treatment regimen of claim 1, wherein said pharmaceutical composition is a cream. 7. The first-line treatment regimen of claim 1, wherein said pharmaceutical composition comprises about 5% of benzoyl peroxide. 8. The first-line treatment regimen of claim 1, wherein said benzoyl peroxide is in a form selected from solid, solution or suspension. 9. The first-line treatment regimen of claim 1, wherein the rosacea is any of erythematotelangiectatic, papulopustular, phymatous or ocular rosacea. 10. The first-line treatment regimen of claim 1, wherein said pharmaceutical composition is an extended-release formulation. 11. The first-line treatment regimen of claim 1, wherein said regimen has an adverse events value similar to or lower than the adverse events value of a vehicle control. 12. The first-line treatment regimen of claim 1, wherein the pharmaceutical composition is physically and chemically stable for a period of at least about 12 weeks. |
