METHODS AND COMPOSITIONS FOR TREATING OR PREVENTING ERYTHEMA
Methods and products for treating or preventing erythema or a symptom associated with erythema in a subject are described. The methods involve topically applying to an affected skin area a topical aqueous gel composition comprising about 0.01% to about 10% by weight of at least one α-adrenergic receptor agonist and a pharmaceutically acceptable carrier.
1 . A method of treating erythema or a symptom associated therewith in a subject, the method comprising topically administering to a skin area of the subject a topical composition comprising about 0.01% to about 10% by weight of at least one alpha 2-adrenergic receptor agonist and a pharmaceutically acceptable carrier, wherein the skin area is, or is prone to be, affected by the erythema or the symptom associated therewith.
2 . The method of claim 1 , wherein the topical composition is selected from the group consisting of an aqueous solution topical formulation, cream topical formulation, and ointment formulation.
3 . The method of claim 1 , wherein the erythema is erythema of rosacea.
4 . The method of claim 1 , wherein the at least one alpha 2-adrenergic receptor agonist is a non-selective alpha 2-adrenergic receptor agonist.
5 . The method of claim 1 , wherein the at least one alpha 2-adrenergic receptor agonist is brimonidine or a pharmaceutically acceptable salt thereof.
6 . The method of claim 5 , wherein the at least one alpha 2-adrenergic receptor agonist is brimonidine tartarate.
7 . The method of claim 1 , further comprising administering to the subject at least one additional treatment and medication for erythema or the symptom associated therewith.
8 . The method of claim 1 , wherein the topical composition is a topical aqueous gel composition.
9 . The method of claim 1 , wherein the topical composition is administered to the skin area once daily.
10 . The method of claim 1 , wherein the topical composition comprises about 0.6% -3% by weight of the at least one alpha 2-adrenergic receptor agonist.
11 . The method of claim 1 , wherein the topical composition comprises about 0.05% -1% by weight of the at least one alpha 2-adrenergic receptor agonist.
12 . The method of claim 1 , wherein the topical composition comprises about 0.3% -0.6% by weight of the at least one alpha 2-adrenergic receptor agonist.
13 . The method of claim 1 , wherein the topical composition comprises about 0.4% -0.6% by weight of the at least one alpha 2-adrenergic receptor agonist.
14 . The method of claim 1 , wherein the topical composition comprises about 0.5% by weight of the at least one alpha 2-adrenergic receptor agonist.
15 . The method of claim 1 , wherein the topical administration of the topical composition to the skin area results in significantly more reduction of the erythema and the symptom compared to a vehicle control as measured by a 12 hour success profile evaluated on both CEA and PSA scales, without causing any unacceptable adverse effect, wherein the 12 hour success profile comprises a noticeable effect of 1-grade improvement of the erythema or the symptom and about 1 hour to about 8 hours of 2-grade improvement of the erythema or the symptom.
16 . A method of treating erythema or a symptom associated therewith in a subject, the method comprising topically administering to a skin area of the subject a topical aqueous gel composition comprising about 0.01% to about 10% by weight brimonidine or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, wherein the skin area is, or is prone to be, affected by the erythema or the symptom associated therewith.
17 . The method of claim 16 , wherein the erythema is facial erythema associated with rosacea, and the topical administration of the topical aqueous gel composition to the skin area results in significantly more reduction of the facial erythema compared to a vehicle control as measured by a 12 hour success profile evaluated on both CEA and PSA scales, without causing any unacceptable adverse effect, wherein the 12 hour success profile comprises a noticeable 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.
18 . A method of treating erythema or a symptom associated therewith in a subject, the method comprising topically administering to a skin area of the subject a topical composition comprising about 0.4 (w/w) to about 0.6% (w/w) brimonidine tartrate and about 0.8% (w/w) to about 1.5% (w/w) carbomer and a pharmaceutically acceptable carrier, wherein the skin area is, or is prone to be, affected by the erythema or the symptom associated therewith.
19 . The method of claim 18 , wherein the topical composition is a topical aqueous gel composition.
20 . The method of claim 19 , wherein the erythema is facial erythema associated with rosacea, and the topical administration of the topical aqueous gel composition to the skin area results in significantly more reduction of the facial erythema compared to a vehicle control as measured by a 12 hour success profile evaluated on both CEA and PSA scales, without causing any unacceptable adverse effect, wherein the 12 hour success profile comprises a noticeable 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.