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Claims for Patent: 9,387,187

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Claims for Patent: 9,387,187

Title:Administration of 6[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders
Abstract: Dermatological disorders having an inflammatory or proliferative component are treated with pharmaceutical compositions containing on the order of 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthanoic acid (adapalene) or salt thereof, formulated into pharmaceutically acceptable media therefor, advantageously topically applicable gels, creams or lotions.
Inventor(s): Graeber; Michael (Lawrenceville, NJ), Czernielewski; Janusz (Biot, FR)
Assignee: GALDERMA RESEARCH & DEVELOPMENT (Biot, FR)
Application Number:14/263,758
Patent Claims: 1. A method for eliciting an early onset of action in regression of inflammatory lesions, regression of non-inflammatory lesions or regression of total acne lesions in treating common acne afflicting an individual's skin, the individual being in need of such treatment, comprising topically administering daily to said individual an anti-acne effective amount of a pharmaceutical composition which comprises 0.3% by weight of 6[-3-(1-adamantyl)]-4-methoxyphenyl-2-naphthoic acid (adapalene) or salt thereof, formulated into a pharmaceutically acceptable medium therefor, said composition being a gel or a cream, wherein said early onset of action occurs by four weeks after treatment begins and is demonstrated by regression of inflammatory lesions, regression of non-inflammatory lesions or regression of total acne lesions after four weeks of treatment greater than that demonstrated by vehicle alone or by a similar composition comprising 0.1% by weight of adapalene after four weeks of treatment.

2. The method according to claim 1, wherein the common acne is of moderate to moderately severe intensity.

3. The method according to claim 1, wherein the composition is a gel comprising adapalene, carbomer 940, disodium edetate, methyl paraben, poloxamer 124, propylene glycol, sodium hydroxide and purified water.

4. The method according to claim 1, wherein the composition comprises a gel.

5. The method according to claim 2, wherein the composition comprises a gel.

6. A method for eliciting an early onset of action in regression of inflammatory lesions in treating common acne afflicting an individual's skin, the individual being in need of such treatment, comprising topically administering daily to said individual an anti-acne effective amount of a pharmaceutical composition which comprises 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid (adapalene) or salt thereof, formulated into a pharmaceutically acceptable medium therefor, said composition being a gel or a cream, wherein said early onset of action occurs by four weeks after treatment begins and is demonstrated by regression of inflammatory lesions after four weeks of treatment greater than that demonstrated by vehicle alone or by a similar composition comprising 0.1% by weight of adapalene after four weeks of treatment.

7. The method according to claim 6, wherein the common acne is of moderate to moderately severe intensity.

8. The method according to claim 6, wherein the composition is a gel comprising adapalene, carbomer 940, disodium edetate, methyl paraben, poloxamer 124, propylene glycol, sodium hydroxide and purified water.

9. The method according to claim 6, wherein the composition comprises a gel.

10. The method according to claim 7, wherein the composition comprises a gel.

11. A method for eliciting an early onset of action in regression of non-inflammatory lesions in treating common acne afflicting an individual's skin, the individual being in need of such treatment, comprising topically administering daily to said individual an anti-acne effective amount of a pharmaceutical composition which comprises 0.3% by weight of 6[-3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid (adapalene) or salt thereof, formulated into a pharmaceutically acceptable medium therefor, said composition being a gel or a cream, said early onset of action occurring by four weeks after treatment begins and being demonstrated by regression of non-inflammatory lesions after four weeks of treatment greater than that demonstrated by vehicle alone or by a similar composition comprising 0.1% by weight of adapalene after four weeks of treatment.

12. The method according to claim 11, wherein the common acne is of moderate to moderately severe intensity.

13. The method according to claim 11, wherein the composition is a gel comprising adapalene, carbomer 940, disodium edetate, methyl paraben, poloxamer 124, propylene glycol, sodium hyrdoxide and purified water.

14. The method according to claim 12, wherein the composition is a gel comprising adapalene, carbomer940, disodium edetate, methyl paraben, poloxamer 124, propylene glycol, sodium hydroxide and purified water.

15. The method according to claim 11, wherein the composition comprises a gel.

16. The method according to claim 12, wherein the composition comprises a gel.

17. A method for eliciting an early onset of action in regression of total acne lesions in treating common acne afflicting an individual's skin, the individual being in need of such treatment, comprising topically administering daily to said individual an anti-acne effective amount of a pharmaceutical composition which comprises 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid (adapalene) or salt thereof, formulated into a pharmaceutically acceptable medium therefor, said composition being a gel or a cream, said early onset of action occurring by four weeks after treatment begins and being demonstrated by regression of total acne lesions after four weeks of treatment greater than that demonstrated by vehicle alone or by a similar composition comprising 0.1% by weight of adapalene after four weeks of treatment.

18. The method according to claim 17, wherein the common acne is of moderate to moderately severe intensity.

19. The method according to claim 17, wherein the composition comprises a gel.

20. The method according to claim 18, wherein the composition comprises a gel.

21. The method according to claim 17, wherein the composition is a gel comprising adapalene, carbomer 940, disodium edetate, methyl paraben, poloxamer 124, propylene glycol, sodium hydroxide and purified water.
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