Compositions and methods for treating rosacea and acne
Provided are compositions and methods for treating rosacea and acne. Specifically, a gel or foam composition having a tetracycline antibiotic and uses thereof for treating rosacea and acne are provided.
1. A method for treating acne vulgaris in a subject in need thereof, comprising topically administering to the subject a therapeutically effective amount of a breakable foam obtained from a foamable composition once daily for at least seven consecutive days, wherein the foamable composition comprises:
(a) a hydrophobic vehicle comprising:
(i) about 70% to about 90% by weight of a hydrophobic solvent comprising:
about 35% w/w to about 65% w/w of soybean oil;
about 16.5% w/w to about 30.7% w/w of coconut oil;
about 3.5% w/w to about 6.5% w/w of cyclomethicone; and
about 1% w/w to about 6% w/w of light mineral oil; and
(ii) about 10% to about 22% by weight of a foamer complex comprising:
about 2.5% w/w to about 4.6% w/w of cetostearyl alcohol;
about 2% w/w to about 4% w/w of stearic acid;
about 1.8% w/w to about 3.3% w/w of myristyl alcohol;
about 1% w/w to about 3% w/w of hydrogenated castor oil;
about 1% w/w to about 3% w/w of beeswax;
about 1% w/w to about 2% w/w of stearyl alcohol; and
about 0.5% w/w to about 1.5% w/w of behenyl alcohol;
(iii) minocycline in an amount ranging from about 1% w/w to about 4% w/w; and
(b) a propellant in an amount ranging from about 3% to about 25% w/w;
wherein the subject is between 15 years old and 16 years and 11 months old, wherein the foamable composition does not comprise silicon dioxide (SiO 2 ), and wherein the minocycline is present in plasma from the subject at a concentration of at most 1.9 ng/mL before applying the seventh day of treatment with the therapeutically effective amount of the breakable foam.
2. The method of claim 1 , wherein the minocycline is present in plasma from the subject at a concentration of about 1.8 ng/mL 3 hours after applying the seventh day of treatment with the therapeutically effective amount of the foam.
3. The method of claim 1 , wherein the minocycline is present in plasma from the subject at a concentration of about 1.8 ng/mL 12 hours after applying the seventh day of treatment with the therapeutically effective amount of the foam.
4. The method of claim 1 , wherein the minocycline is present in plasma from the subject at a concentration of about 1.6 ng/mL 16 hours after applying the seventh day of treatment with the therapeutically effective amount of the foam.
5. The method of claim 1 , wherein the minocycline is present in plasma from the subject at a concentration of about 1.5 ng/mL 24 hours after applying the seventh day of treatment with the therapeutically effective amount of the foam.
6. The method of claim 1 , wherein a maximum measured plasma concentration in the subject is reached about 6 hours after a daily topical administration.
7. The method of claim 1 , wherein the concentration of minocycline present in plasma from the subject at day 8 is about the same or less than the concentration before applying the seventh day of treatment.
8. The method of claim 1 , wherein the plasma concentration is a mean concentration.
9. A method of treating acne vulgaris in a subject in need thereof, comprising topically administering to the subject a therapeutically effective amount of a breakable foam obtained from a foamable composition once daily for at least seven consecutive days, wherein the foamable composition comprises:
(a) a hydrophobic vehicle comprising:
(i) about 70% to about 90% by weight of a hydrophobic solvent comprising:
about 35% w/w to about 65% w/w of soybean oil;
about 16.5% w/w to about 30.7% w/w of coconut oil;
about 3.5% w/w to about 6.5% w/w of cyclomethicone; and
about 1% w/w to about 6% w/w of light mineral oil; and
(ii) about 10% to about 22% by weight of a foamer complex comprising:
about 2.5% w/w to about 4.6% w/w of cetostearyl alcohol;
about 2% w/w to about 4% w/w of stearic acid;
about 1.8% w/w to about 3.3% w/w of myristyl alcohol;
about 1% w/w to about 3% w/w of hydrogenated castor oil;
about 1% w/w to about 3% w/w of beeswax;
about 1% w/w to about 2% w/w of stearyl alcohol; and
about 0.5% w/w to about 1.5% w/w of behenyl alcohol;
(iii) minocycline in an amount ranging from about 1% w/w to about 4% w/w; and
(b) a propellant in an amount ranging from about 3% to about 25% w/w;
wherein the subject is between 15 years old and 16 years and 11 months old, wherein the foamable composition does not comprise silicon dioxide (SiO 2 ), wherein the minocycline is present in plasma from the subject, and wherein an area under a concentration-time curve of the amount of minocycline in the plasma from the subject is 40.8 (ng/mL)*hour or less, as determined during a 24 hour period following a topical administration of the therapeutically effective amount of the breakable foam.
10. The method of claim 9 , wherein the area is a mean area.