PHARMACEUTICAL CREAM COMPOSITIONS OF OXYMETAZOLINE AND METHODS OF USE
The present invention is directed to: a) a method of treating telangiectasia; b) a method of treating inflammatory lesions; and c) a method of treating two or more symptoms of rosacea selected from erythema, telangiectasia, or inflammatory lesions comprising topical administration of a pharmaceutical composition comprising oxymetazoline and a pharmaceutically acceptable excipient.
1 . A method of treating inflammatory lesions associated with rosacea comprising topically administering a pharmaceutical composition comprising a therapeutically effective amount of oxymetazoline or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient.
2 . The method of claim 1 , wherein the inflammatory lesions are selected from the group consisting of papules, pustules, cysts and phymas.
3 . The method of claim 1 , wherein the pharmaceutically acceptable salt of oxymetazoline is oxymetazoline hydrochloride.
4 . The method of claim 1 , wherein the composition further comprises an additive selected from the group consisting of emulsifiers, preservatives, emulsion stabilizers, pH adjusters, chelating agents, viscosity modifiers, anti-oxidants, surfactants, emollients, opacifying agents, skin conditioners, buffers, and combinations thereof.
5 . The method of claim 1 , wherein the composition further comprises a topically active pharmaceutical or cosmetic agent.
6 . The method of claim 5 , wherein the topically active pharmaceutical or cosmetic agent is selected from a group consisting of an anti-rosacea agent, an antibacterial agent, an antimycobaterial agent, an anti-acne agent, an anti-parasitic agent, an antifungal agent, an steroidal anti-inflammatory agent, an non-steroidal anti-inflammatory agent, an anesthetic agent, an anti-pruriginous agent, an anti-free radical agent, an anti-seborrheic agent, an antipsoriatic agent, a tricyclic anti-depressant, an antihistamine, and a chemotherapeutic agent.
7 . The method of claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount of from about 0.0075% to about 5% by weight.
8 . The method of claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount of from about 0.0075% to about 3% by weight.
9 . The method of claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount from about 0.01% to about 2.5% by weight.
10 . The method of claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount from about 0.01% to about 2% by weight.
11 . The method of claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount from about 0.01% to about 1% by weight.
12 . The method of claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount from about 0.01% to about 0.5% by weight.
13 . The method of claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount from about 0.01% to about 0.25% by weight.
14 . The method of claim 1 , wherein the oxymetazoline or the pharmaceutically acceptable salt thereof is in an amount from about 0.01% to about 0.15% by weight.
15 . The method of claim 1 , wherein the therapeutic effect of the composition is maintained for at least about 30 days after final administration of the composition.
16 . The method of claim 1 , wherein the therapeutic effect of the composition is maintained for at least about 20 days after final administration of the composition.
17 . The method of claim 1 , wherein the therapeutic effect of the composition is maintained for at least about 10 days after final administration of the composition.
18 . The method of claim 1 , wherein the composition further comprises an additional therapeutic for the treatment of non-inflammatory manifestations of rosacea such as telangiectasias, erythema, epidermal barrier dysfunction, or other manifestation of rosacea.
19 . The method of claim 18 , wherein the additional therapeutic is selected from the group consisting of a selective alpha-1 adrenoreceptor agonist, a selective alpha-2 adrenoreceptor agonist, a non-selective alpha-1 adrenoreceptor agonist, a non-selective alpha-2 adrenoreceptor agonist, and a combination thereof.
20 . The method of claim 1 , wherein administration of the composition is in combination with another therapy directed toward the treatment of inflammatory lesions.