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Claims for Patent: 8,809,305

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Claims for Patent: 8,809,305

Title:Administration of adapalene and benzoyl peroxide for the long-term treatment of acne vulgaris
Abstract: A regimen for the safe and effective long-term treatment of acne vulgaris entails topically applying onto the affected skin area of a subject afflicted therewith, for a period of time of at least four (4) months, e.g., for at least twelve (12) months and advantageously on a daily basis and preferably once a day, a thus effective amount of a topical medicament containing adapalene and benzoyl peroxide, formulated into a pharmaceutically acceptable medium therefor.
Inventor(s): Graeber; Michael (Lawrenceville, NJ), Liu; Yin (Princeton Junction, NJ), Gore; Barbara (Cranbury, NJ)
Assignee: Galderma Research & Development (Biot, FR)
Application Number:12/458,982
Patent Claims: 1. A regimen for the safe and effective long-term treatment of acne vulgaris, comprising topically applying onto an affected skin area of a subject afflicted therewith, at least once every two days for a period of time of at least six (6) months, a thus effective amount of a topical medicament which comprises a fixed-dose combination of 0.1% to 0.3% by weight of adapalene and 2.5% by weight of benzoyl peroxide, formulated into a pharmaceutically acceptable medium therefor, said adapalene and said benzoyl peroxide being the only anti-acne active ingredients in said fixed-dose combination, the percentage by weight being relative to the total weight of the topical medicament.

2. The regimen for long-term treatment of acne vulgaris as defined by claim 1, comprising administering said topical medicament for at least twelve (12) months.

3. The regimen for the long-term treatment of acne vulgaris as defined by claim 1, comprising administering said topical medicament for at least nine (9) months.

4. The regimen for long-term treatment of acne vulgaris as defined by claim 1, comprising administering said topical medicament once a day.

5. The regimen for long-term treatment of acne vulgaris as defined by claim 1, comprising administering said topical medicament every two (2) days.

6. The regimen for the long-term treatment of acne vulgaris as defined by claim 1, comprising administering said topical medicament in the evening after washing said affected skin area.

7. The regimen for the long-term treatment of acne vulgaris as defined by claim 1, said topical medicament comprising a gel composition.

8. The regimen for the long-term treatment of acne vulgaris as defined by claim 4, comprising administering said topical medicament for at least nine (9) months.

9. The regimen for the long-term treatment of acne vulgaris as defined by claim 4, comprising administering said topical medicament for at least twelve (12) months.

10. The regimen for the long-term treatment of acne vulgaris as defined by claim 1, wherein the topical medicament comprises 0.1% by weight of adapalene and 2.5% by weight of benzoyl peroxide, relative to the total weight thereof.

11. The regimen for the long-term treatment of acne vulgaris as defined by claim 1, said affected skin area containing from 20 to 100 non-inflammatory lesions, 20 to 50 inflammatory lesions, and no active nodules or cysts.
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