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Claims for Patent: 8,513,247

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Claims for Patent: 8,513,247

Title:Methods and compositions for safe and effective treatment of erythema
Abstract: Improved methods and compositions for safe and effective treatment of erythema or a symptom associated with erythema in a subject are described. The methods involve topically applying to an affected skin area a topical composition comprising about 0.4% to about 0.6% by weight of brimonidine and a pharmaceutically acceptable carrier.
Inventor(s): Graeber; Michael (Lawrenceville, NJ), Loesche; Christian (Valbonne, FR), Freidenreich; Philip (Yardley, PA), Liu; Yin-Sang (Princeton, NJ), Leoni; Matthew J. (Hampton, NJ)
Assignee: Galderma Laboratories, L.P. (Fort Worth, TX)
Application Number:13/072,096
Patent Claims: 1. A method of treating erythema or a symptom associated therewith in a subject, comprising topically administering to a skin area affected by the erythema or the symptom a topical composition comprising, relative to the total weight of the composition, 0.4% to 0.6% by weight of brimonidine and a pharmaceutically acceptable carrier, wherein the topical administration results in more reduction of the erythema or the symptom compared to a vehicle control as measured by a 12 hour success profile evaluated on both Clinician's Erythema Assessment scores and Patient's Self Assessment scales without causing unacceptable drug related adverse events, and the 12 hour success profile comprises at least 1-grade improvement of the erythema or the symptom.

2. The method of claim 1, wherein the erythema is erythema of rosacea.

3. The method of claim 1, further comprising providing to the subject at least one additional treatment and medication for erythema or the symptom associated therewith.

4. The method of claim 1, wherein the topical composition is administered to the skin area once daily.

5. The method of claim 1, wherein the 12 hour success profile further comprises about 1 hour to about 8 hours of 2-grade improvement of the erythema or the symptom.

6. The method of claim 5, wherein the erythema or the symptom is facial erythema associated with rosacea, and the 12 hour success profile comprises an effect of 1-grade improvement of the facial erythema and about 3 hours to about 6 hours of 2-grade improvement of the facial erythema.

7. The method of claim 1, wherein the topical composition further comprises, relative to the total weight of the composition, about 0.20% to about 4.0% by weight of gelling agent; and about 5.0% to about 15.0% by weight of at least one polyol.

8. The method of claim 7, wherein the brimonidine is brimonidine tartrate.

9. The method of claim 8, wherein the topical composition comprises, relative to the total weight of the composition, about 0.5% by weight of brimonidine tartrate.

10. The method of claim 7, wherein the topical composition comprises, relative to the total weight of the composition, about 0.50% to about 2.0% by weight of of the gelling agent, and the gelling agent comprises a carbomer.

11. The method of claim 10, wherein the carbomer is selected from the group consisting of carbomer 934P, carbomer 974P, and carbomer 980.

12. The method of claim 7, wherein the topical composition further comprises, relative to the total weight of the composition, about 0.04% to about 0.08% by weight of water dispersible form of titanium dioxide.

13. The method of claim 7, wherein the topical composition further comprises a preservative selected from the group consisting of sodium benzoate, phenoxyethanol, benzyl alcohol, methylparaben, imidazolidinyl urea and diazolidinyl urea.

14. The method of claim 7, wherein the at least one polyol comprises at least one of glycerin and propylene glycol.

15. A method of producing a packaged product for treating erythema or a symptom associated therewith in a subject, comprising: (1) obtaining a topical composition comprising, relative to the total weight of the composition, 0.4% to 0.6% by weight of brimonidine and a pharmaceutically acceptable carrier; (2) devising instructions for topically administering the topical composition to a skin area affected by the erythema or the symptom to obtain the treatment, and (3) providing the topical composition and the instructions in a unified package for the subject, wherein the topical administration results in more reduction of the erythema or the symptom compared to a vehicle control as measured by a 12 hour success profile evaluated on both Clinician's Erythema Assessment scores and Patient's Self Assessment scales without causing unacceptable drug related adverse events, and the 12 hour success profile comprises at least 1-grade improvement of the erythema or the symptom.

16. A topical composition for treating erythema or a symptom associated therewith in a subject, comprising, relative to the total weight of the composition: 0.4% to 0.6% by weight of brimonidine; and a pharmaceutically acceptable carrier, wherein the topical administration of the topical gel composition to a skin area affected by the erythema or the symptom results in more reduction of the erythema or the symptom compared to a vehicle control as measured by a 12 hour success profile evaluated on both Clinician's Erythema Assessment scores and Patient's Self Assessment scales without causing unacceptable drug related adverse events, and the 12 hour success profile comprises at least 1-grade improvement of the erythema or the symptom.

17. The topical gel composition of claim 16, wherein the brimonidine is brimonidine tartrate.

18. The topical gel composition of claim 17 comprising, relative to the total weight of the composition, about 0.5% by weight of brimonidine tartrate.

19. The topical gel composition of claim 16, further comprising, relative to the total weight of the composition, about 0.50% to about 2.0% by weight of a carbomer.

20. The topical gel composition of claim 16, further comprising at least one of glycerin and propylene glycol.

21. The method of claim 1, wherein the erythema or the symptom associated therewith is facial erythema associated with rosacea, and the topical composition comprises about 0.5% by weight of brimonidine tartrate relative to the total weight of the composition.

22. The topical composition of claim 16, wherein the 12 hour success profile further comprises about 1 hour to about 8 hours of 2-grade improvement of the erythema or the symptom.

23. The topical composition of claim 22, wherein the erythema or the symptom is facial erythema associated with rosacea, and the 12 hour success profile comprises an effect of 1-grade improvement of the facial erythema and about 3 hours to about 6 hours of 2-grade improvement of the facial erythema.
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