Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Reexamination Certificate
1999-02-03
2001-01-16
Dudash, Diana (Department: 1619)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
C514S938000
Reexamination Certificate
active
06174534
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates to a composition and a method for preventing and/or treating rosacea, which includes a cosmetic composition containing at least from 1 to 5% of a Cl
2
-C
24
fatty acid, from 5 to 15% of an ester of C
12
-C
24
fatty acid and of a C
2
-C
3
polyalkylene oxide fragment containing from 2 to 100 polyalkylene oxide residues, from 1 to 20% of an optionally polyoxyalkylenated C
12
-C
22
fatty acid glyceride containing from 0 to 20 ethylene oxide residues, from 1 to 20% of an ester of a C
12
-C
24
fatty acid and of a C
1
-C
6
alcohol, from 0.1 to 10% of glycerol, from 0.1 to 20% of an ester of a C
12
-C
24
fatty acid and of a C
1
-C
6
alcohol, from 0.1 to 10% of glycerol, from 0.1 to 3% of a C
12
-C
24
fatty alcohol, this composition comprising water and not comprising any metronidazole.
2. Discussion of the Background
Rosacea, which is also referred to incorrectly as acne rosacea, is a common dermatitis mainly affecting the face in women between 30 and 50 years old, the main symptoms of which are: erythrosis of the face, couperose with telangiectasic dilatations and papulo-pustular lesions. The mechanisms giving rise to the appearance of rosacea are poorly understood, and many factors are liable to promote rosacea. For further information on this subject, reference may be made to the following articles: “Current developments in rosacea”, H.N. Mouaci-Midoun, Abstract Dermato Hebdo No. 309, 27.01.1997, pp. 15-19; “Rosac{acute over (e)}e: les traitements classiques (Rosacea: Standard treatments)”, J.-M. Mazer and T. Fusade, R{acute over (e)}alit{acute over (e)}s th{acute over (e)}rapeutiques en Dermato-V{acute over (e)}n{acute over (e)}rologic, No. 52, November 1995, pp. 8-12.
French dermatologists have for many years been using, as an authoritative preparation, metronidazole in the cream Physiane® sold by the company La Roche Posay for the treatment of rosacea.
The efficacy of these preparations in treating rosacea was attributed to metronidazole (antiparasitic agent), which remains, along with the cyclines (antibiotics), one of the compounds most commonly prescribed in the treatment of rosacea, irrespective of the support in which it is incorporated.
Moreover, Physiane® was hitherto recommended as a moisturizing cream to complement standard anti-acne treatments. However, there is no link between acne and rosacea, which are two different skin complaints, and the applicant limited itself to prescribing it for its efficacy in moisturizing the skin.
In order to be effective, the current treatments for rosacea are often prescribed over long periods. However, the prolonged use of active molecules such as antibiotics is undesirable, in particular since this can induce resistance of certain bacterial strains to these molecules. In addition, the use of cyclines and of metronidazole are contra-indicated in pregnant women.
Consequently, there remains a need for a treatment for rosacea which can be used by all individuals, over a prolonged period and without any side effects.
SUMMARY OF THE INVENTION
Thus, the inventors have discovered, surprisingly, that the cream Physiane® alone, without metronidazole, is an effective equivalent to the standard treatments based on metronidazole for treating rosacea.
Accordingly, one embodiment of the invention relates to a composition for the prevention and/or treatment of rosacea, that includes at least the following constituents (i) to (vii), the percentages being given by weight relative to the total weight of the cosmetic composition:
(i) from 1 to 5% of at least one C
12-C
24
fatty acid;
(ii) from 5 to 15% of at least one ester of C
12
-C
24
fatty acid and of a C
2
-C
3
polyalkylene oxide fragment containing from 2 to 100 alkylene oxide residues;
(iii) from 1 to 20% of at least one optionally polyoxyalkylenated C
12
-C
22
fatty acid glyceride containing from 0 to 20 alkylene oxide residues;
(iv) from 1 to 20% of at least one ester of a C
12
-C
24
fatty acid and of a C
1
-C
6
alcohol;
(v) from 0.1 to 10% of glycerol;
(vi) from 0.1 to 3% of a C
12
-C
24
fatty alcohol;
(vii) from 50 to 85% of water;
wherein the composition is free from any of metronidazole, lanthanide, tin, zinc, manganese, yttrium, cobalt, barium or strontium salt, and non-photosynthetic filamentous bacteria.
Such a composition can be applied for a prolonged period in total safety, which makes it possible to envisage using it both for treating rosacea, for which its efficacy has been illustrated below, and for preventing rosacea, by a daily use outside of the periods during which the symptoms are present.
Another embodiment of the invention is a method for treating and/or preventing rosacea, that includes applying the above composition of the invention to the skin of a person in need thereof.
Another object of the invention is a method for reducing the papulopustules due to rosacea, that includes applying the above composition of the invention to the skin of a person in need thereof.
Another object of the invention is a method for reducing the erythema associated with rosacea, that includes applying the above composition of the invention to the skin of a person in need thereof.
Another object of the invention is a method for reducing the telangiectasia associated with rosacea, that includes applying the above composition of the invention to the skin of a person in need thereof.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Various other features, objects and attendant advantages of the present invention will be more fully appreciated as the same becomes better understood from the following detailed description, which is not intended to be limiting unless otherwise specified.
Preferably, the composition of the invention satisfies at least one or more, and preferably all, of the conditions below:
the constituent (i) is a C
16
-C
20
fatty acid, preferably stearic acid;
the constituent (i) is present in an amount ranging from 2 to 4%, preferably from 2.5 to 3.5%, by weight relative to the total weight of the composition;
the constituent (ii) is a C
16
-C
20
fatty acid ester, preferably a stearic acid ester;
the constituent (ii) is a fatty acid ester of polyethylene oxide;
the constituent (ii) is a mixture of esters of fatty acids and of polyalkylene oxide containing, for at least one ester, from 2 to 15 alkylene oxide residues, and, for at least one ester, from 20 to 50 alkylene oxide residues;
the constituent (ii) is a mixture of fatty acid esters of polyalkylene oxide, the HLB value (defined below) of the mixture ranging from 9 to 15, preferably from 11 to 14;
the constituent (ii) is present in an amount ranging from 7 to 13%, preferably from 9 to 11%, by weight relative to the total weight of the composition;
the constituent (iii) is a mixture of at least one C
12
-C
22
fatty acid glyceride and of at least one polyoxyethylenated C
12
-C
22
fatty acid glyceride containing from 2 to 20 ethylene oxide residues;
the constituent (iii) is a mixture of hydrogenated palm oil and of palm kernel oil polyoxyethylenated with 4 to 10 ethylene oxide residues;
the constituent (iii) is present in amounts ranging from 1 to 10%, preferably from 2 to 5%, by weight relative to the total weight of the composition;
the constituent (iv) is a C
14
-C
18
fatty acid ester, preferably a palmitic acid ester;
the constituent (iv) is a fatty acid ester of a C
2
-C
4
alcohol, preferably a fatty acid ester of isopropyl alcohol;
the constituent (iv) is present in an amount ranging from 1 to 10%, preferably from 2 to 6%, by weight relative to the total weight of the composition;
the constituent (v) is present in an amount ranging from 0.5 to 5%, preferably from 0.5 to 3%, by weight relative to the total weight of the composition;
the constituent (vi) is a C
14
-C
18
fatty alcohol, preferably cetyl alcohol;
the constituent (vi) is present in an amount ranging from 0.1 to 1%, preferably from 0.2 to 0.8%, by weight relative to the total weight of the composition;
the constituent (vii) is at least partly a mineral or spring water, prefera
Brissonnet Jean Pierre
Richard Alain
Berman Alysia
Dudash Diana
La Roche Posay Laboratoire
Oblon & Spivak, McClelland, Maier & Neustadt P.C.
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