HK1095283B - Use of a sunflower oil product for skin treatments - Google Patents

Description

The present invention relates to the use of a sunflower oil product as an agent to increase the synthesis of skin lipids, including lipids from the epidermal skin barrier, in or for the preparation of a cosmetic, pharmaceutical or dermatological composition. The invention also relates to a cosmetic treatment method to increase the synthesis of skin lipids, including lipids from the epidermal skin barrier, and to the use of the plant product as a food additive.

The skin is mainly made up of three layers: the epidermis, dermis, and hypodermis.

The outermost layer, the epidermis, is characterised by a stratum organisation corresponding to an increasing state of keratinocyte differentiation, from the deepest zone (basal stratum) to the most superficial zone (stratum comeum) in which anucleated elements (corneocytes) are included in a multi-lamellar extracellular lipid structure, the intercorneocytic cement, responsible for the function of water barrier of the skin and protection against external aggression.

The lamellar or Oddland bodies, secreted by the stratum granulosum, the intermediate layer between the stratum basalis and stratum corneum, contain cholesterol, phospholipids and glucosylceramides as well as selective hydrolysis enzymes, which convert phospholipids and glucosylceramides into free fatty acids and ceramides, which together with cholesterol and cholesterol sulfate form the intercellular lamellar bilayers of the stratum comeum. Ceramides are involved in the formation of the stratum corneum barrier and in regulating the fluid flow by solidifying lamellar tissue.

The alteration of this skin barrier caused by external aggressions (UV radiation, wind, cold, detergents, etc.), by the natural and inexorable phenomenon of aging and/or by pathological or non-pathological dysfunctions (sensitive, irritated, or reactive skin) results in a disturbance of epidermal homeostasis which is desirable to be able to prevent and/or treat both cosmetically and pharmaceutically and especially dermatologically.

Err1:Expecting ',' delimiter: line 1 column 91 (char 90)

There is therefore a need to stimulate the synthesis of skin lipids, in particular lipids from the epidermal barrier, in order to restore the epidermal barrier function and/or to combat various skin disorders related to a decrease in the synthesis of skin lipids, in particular lipids from the epidermal barrier.

Patent FR 2 692 783 describes compositions based on wheat germ oil insaponifiables in combination with sesame oil insaponifiables. The mixture of sesame oil insaponifiables and wheat germ oil insaponifiables has curative activity against UVA effects, but the text does specify that vitamin E alone or each of the above mentioned insaponifiables does not have curative action against these effects.

Patent DE 196 52 522 describes a process for the concentration of tocopherols and/or sterols from mixtures of fats and/or fat derivatives, in which the mixture is subjected to fractional distillation and molecular distillation.

US Patent 4,454,159 describes compositions for the dermatological treatment of dry, irritated skin. These compositions are mixtures of many products such as lipid/lipoid combinations with antioxidant properties and/or rich in specific fatty acids.

Patent FR 2 471 775 presents a new oil for cosmetic use containing a mixture of jojoba oil and sunflower oil and an unsaponifiable fraction, in particular soybean or avocado, and/or pistachio oil.

It has now been found quite surprisingly and unexpectedly that the use of certain sunflower oil products has a beneficial effect on the synthesis of lipids in the skin, particularly lipids in the epidermal skin barrier.

The present invention thus concerns the use of at least one sunflower oil product selected from the group consisting of sunflower oil oleodistillate, sunflower oil insaponifiable, and their mixtures, according to claims 1 or 5.

In particular, the use according to the invention is characterised by the selection of skin lipids from amongst others epidermal lipids of the group consisting of cholesterol, cholesterol sulphate, ceramides 1 and 2 and mixtures thereof.

Err1:Expecting ',' delimiter: line 1 column 47 (char 46)

The unsaponifiable is the fraction of a fatty body which, after prolonged action of an alkaline base, remains insoluble in water and can be extracted by an organic solvent.

Err1:Expecting ',' delimiter: line 1 column 279 (char 278)

Different methods can be used to concentrate the unsaponifiable fraction of a vegetable oil: cold crystallization, liquid-liquid extraction, molecular distillation.

Molecular distillation is particularly preferred, being preferably carried out at a temperature of about 180 to about 260 °C maintaining a pressure of about 10-3 to about 10-2 mmHg and preferably in the order of 10-3 mmHg.

This molecular distillation, as well as any other molecular distillation for the preparation of sunflower oil products to be used according to the invention, as described below, is preferably performed using a device selected from the molecular centrifuge type distillers and the molecular scrap film type devices.

The distillation chamber is placed in a vacuum. Under these conditions, there is evaporation, not boiling, of constituents of the unsaponifiable, since oil and unsaponifiable (being considered fragile products) are not degraded during evaporation.

Scrap film molecular distillers, also known as a professional one, include a distillation chamber with a rotating scraper, allowing continuous spreading on the evaporation surface (hot surface) of the product to be distilled. The product vapours are condensed through a refrigerated finger, placed in the center of the distillation chamber. The peripheral feeding and vacuum systems are very similar to those of a centrifugal distiller (feeding pumps, pallet and oil diffusion vacuum pumps, etc.).

A particularly preferred embodiment of the present invention is an oil distillate of sunflower oil.

Sunflower oil distillate is preferably obtained by molecular distillation of edible sunflower oil. The distillation rate is approximately 5 to 10% by mass.

The rate of distillation can be defined as follows: it is the mass ratio of the distillate mass to 100% of the sum (mass of the distillate + mass of the residue).

The resulting distillate, i.e. sunflower oil distillate, has a unsaponifiable content of between about 6% and about 10% by weight, the remainder being composed of the triglycerides of sunflower oil.

Several processes have been described in the previous art to extract the unsaponifiable fraction of a vegetable oil.

In particular, the process of preparing avocado oil soap-free as described and claimed in patent FR-2 678 632 on behalf of Laboratori Pharmascience enables the production of an avocado soap-free high in H-fraction compared to conventional avocado soap-free processes.

In this process, the soybean oil is distilled in a centrifuge or film-filled molecular distiller, obtained from a concentrated soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya soya

The sunflower oil product as described above shall be used in a proportion of approximately 0,01 to 100% by weight, preferably between approximately 0,5 and approximately 10% by weight, of the total weight of the composition.

The cosmetically, pharmaceutically or dermatologically acceptable medium may be any medium suitable for the galenic forms known to the professional for topical or oral administration.

In particular, this medium may be an oily solution, an oil-in-water emulsion, an oil-in-water emulsion, a microemulsion, an oily gel, an anhydrous gel, a dispersion of vesicles, microcapsules or microparticles.

Preferably, the composition for use according to the invention is suitable for topical administration.

The beneficial effect of increasing the synthesis of skin lipids, especially lipids from the epidermal skin barrier, allows the prevention and/ or treatment, in other words, allows the treatment of alterations in the skin barrier formed mainly by the epidermal layers of the stratum corneum and granulosum as explained above.

Thus, the use according to the invention is characterised by the fact that the composition is intended for the treatment of dry skin and skin that has been subjected to actinic radiation, in particular UV radiation such as sunlight or UV light, for example during a tanning session.

The use according to the invention is also characterised by the fact that the composition is intended for the treatment of ichthyosis, acne, xerosis, atopic dermatitis (or atopic eczema), skin peeling disorders, sensitive, irritated and reactive skin and pruritus.

The present invention is also for cosmetic use according to claim 5 of skin, mucous membranes and/or pharyngeal ageing disorders, characterized by the application to the skin, mucous membranes and/or pharyngeal ageing of a composition containing at least one sunflower oil product in a cosmetically acceptable medium as described above.

The invention also has a cosmetic use according to claim 5 of the disorders related to drying of the skin, neighboring mucous membranes and/or pimples, characterised by the application to the skin, neighboring mucous membranes and/or pimples of a composition containing at least one sunflower oil product in a cosmetically acceptable medium as described above.

The invention also relates to a cosmetic use according to claim 5 of disorders of the skin, neighboring mucous membranes and/or pimples resulting from exposure to actinic radiation, including UV radiation, characterised by the application to the skin and/or pimples of a composition containing at least one sunflower oil product in a cosmetically acceptable medium as described above.

According to a preferred method of implementation, the sunflower oil product is present in the composition in a proportion of about 0.01 to 100% by weight, preferably between about 0.5 and about 10% by weight, in relation to the total weight of the composition.

Finally, the invention also concerns the use of at least one sunflower oil product, as described above, as an additive in foodstuffs for human and/or animal consumption.

This food use is preferably characterised by the presence of the sunflower oil product in the food in a proportion of about 0,1% to about 20% by weight, in relation to the total weight of the food.

The following examples are intended to illustrate the present invention and should not be construed as limiting its scope.

Unless otherwise specified, the percentages shown in the following examples are weighted percentages.

Example 1: Preparation of vegetable oil products and their use according to the invention as oil-in-water emulsions

Err1:Expecting ',' delimiter: line 1 column 431 (char 430)

1.1) Composition 1.1: use of an oil distillate of sunflower oil

A sunflower oil distillate is prepared by molecular distillation in a molecular centrifuge-type distiller of a commercial edible sunflower oil.The distillation conditions are as follows:temperature 220 °C;pressure 10-3 mmHg;distillation rate: 6.7% mass.Feed rate: 18 kg/h.

Err1:Expecting ',' delimiter: line 1 column 280 (char 279)

Eau	67,3
Glycérine	4
Sorbitan Tristearate	1,85
Peg 40 Stearate	3,15
Silicone SF 1202	3
Cetiol Oe	1
Vaseline Codex	2,5
Glycéryl Stearate	6
Decyl Pentanoate	3
2
Beeswax	3
Stearate Peg 2	1
C12-15 Alcool Benzoate	1
Phenonip	0,7
Sepigel 305	0,5

1.2 Comparative composition: use of a mixture of an avocado and soybean unsaponifiable

Err1:Expecting ',' delimiter: line 1 column 197 (char 196)

Eau	67,3
Glycérine	4
Sorbitan Tristearate	1,85
Peg 40 Stearate	3,15
Silicone SF 1202	3
Cetiol Oe	1
Vaseline Codex	2,5
Glycéryl Stearate	6
Decyl Pentanoate	3
2
Beeswax	3
Stearate Peg 2	1
C12-15 Alcool Benzoate	1
Phenonip	0,7
Sepigel 305	0,5

1.3: use of furanic lipids in avocados

An avocado soap-free is prepared as described in patent FR-2 678 632. Polyhydroxylated fatty alcohols 24,3% furan lipids 55,5% sterols 3,1% squalene 1,4%, other 15,7% (1) (1) free fatty acids, hydrocarbons, tocopherols, fatty ketones and heavy pigments

Err1:Expecting ',' delimiter: line 1 column 211 (char 210)

Composition of the distillate:

Err1:Expecting ',' delimiter: line 1 column 208 (char 207)

Err1:Expecting ',' delimiter: line 1 column 200 (char 199)

Eau	69
Glycérine	4
Sorbitan Tristearate	1,85
Peg 40 Stearate	3,15
Silicone SF 1202	3
Cetiol Oe	1
Vaseline Codex	2,5
Glycéryl Stearate	6
Decyl Pentanoate	3
0,3
Beeswax	3
Stearate Peg 2	1
C12-15 Alcool Benzoate	1
Phenonip	0,7
Sepigel 305	0,5

1.4) Composition of the placebo

Eau	69,3
Glycérine	4
Sorbitan Tristearate	1,85
Peg 40 Stearate	3,15
Silicone SF 1202	3
Cetiol Oe	1
Vaseline Codex	2,5
Glycéryl Stearate	6
Decyl Pentanoate	3
Beeswax	3
Stearate Peg 2	1
C12-15 Alcool Benzoate	1
Phenonip	0,7
Sepigel 305	0,5

Example 2: in vitro evaluation of the effect of compositions 1.1, 1.2, 1.3, and placebo on epidermal lipid metabolism in an organotypic model of whole human skin in culture

The following abbreviations shall be used: The following are the main characteristics of the test chemical: EGF: epidermal growth factor, epidermal growth factor, CCM: thin-layer chromatography, MCF: human skin disc culture medium, MIF: human skin disc incubation medium, PBS: phosphate saline buffer, phosphate buffered saline.

The purpose of this study is to investigate the effect of the four compositions 1.1, 1.2, 1.3 and placebo described above on epidermal lipid metabolism.

The study is carried out in vitro in an organotypic model of whole human skin in culture. measurement of the incorporation of radiolabelled carbon-14 acetate into the totum of neosynthetised epidermal lipids; analysis by thin-film chromatography to separate the main classes of neosynthetised radiolabelled epidermal lipids.

The effect of the test products is compared to that observed in the presence of epidermal growth factor (EGF) diluted in the human skin disc culture medium and in the presence of a commercially available cosmetic formulation containing lactic acid. Both EGF and lactic acid are known to stimulate keratinocyte synthesis of ceramides (Ponec M. Gibbs S., Weer A., Kempenaar J., Mulder A. and Mommaas A.M. - Epidermal growth factor and temperature regulate keratinocyte differentiation function - Arch. Dermatol. Res., 1997, 289, 317-326; Rawlings A.V., Davies A., Carlomusto M., Pillai S. Ahang Kostboid R., Verde K., Feinberg P., P. Chandar, P. P., and Chandar - Arch. Res., 283-390 - Effect of keratinocyte on stratum iron and ceramic acid levels - Arch. Res., 283-390 - Res., 288, 1996).

1) Materials and method 1.1) Test products, reference products and reagents

Err1:Expecting ',' delimiter: line 1 column 243 (char 242)

The solution for rinsing human skin discs after incubation is the PBS buffer: NaCl 8g/l; Na2HPO4 1.15g/l; KH2PO4 0.2g/l; KCI 0.2g/l; CaCl2 0.1g/l; MgCl2 0.1g/l; pH 7.4.

The other reagents, of analytical quality, are sourced from CARLO ERBA, GIBCO and SIGMA, unless otherwise stated.

1.2) Testing system

A human skin fragment was collected following an abdominal plastic surgery on a 24-year-old woman (case 10129).

The skin discs are deposited in nacelles, which are placed in culture wells containing MCF, which is composed of MEM/M199 (3/4, 1/4 v/v) with penicillin (50 IU/ml), streptomycin (50 μg/ml), sodium bicarbonate (0.2%, p/v) and SVF (2%, v/v).

1.3) Incubation of test and reference products with the test system

The test products are tested undiluted and deposited at the centre of each human skin disc at a rate of 10 mg/cm2 The incubation medium of the human skin discs (MIF medium) is composed of MCF medium containing 1 μCi/ml carbon-14 labeled acetate (AMERSHAM, specific activity: 57 mCi/mmole).

The EGF is tested at 10 ng/ml in the MIF medium.

The human skin discs are incubated in the presence of test and reference products for 18 hours at 37°C in a humid atmosphere containing 5% CO2.

The test chemical is then applied to the skin of the test chemical.

Each test condition is performed in quadruplicate.

The following time scale is used: ↑ : topical application of test and reference products and dilution of EGF in the incubation medium of skin discs Δ: addition of carbon-14 marked acetate in the culture medium□: dermal/epidermal dissociation and evaluation of effects

1.4) Assessment of effects 1.4.1) Neosynthesis of total epidermal lipids

At the end of incubation, the human skin discs are thoroughly rinsed with PBS buffer. The epidermis of each skin disc is separated from the dermis by a controlled thermal shock (MilliQ water, 2 min, 62°C). The thus dissociated epidermis is digested by trypsin (ICN, 1%, p/v) overnight at 37°C. Cell dissociation is facilitated by ultrasound.

The newly synthesised lipids, labeled at carbon 14, are extracted by partitioning between an organic phase (methanol/chlorophorm, 1/4, v/v) and an aqueous phase (potassium chloride at 0.25 M).

The radioactivity of each sample, corresponding to the amount of acetate incorporated into the newly synthesised lipids, shall be measured by liquid scintillation.

The results are expressed in cpm/mg of epidermis.

1.4.2) Nature of the newly synthesized epidermal lipids

From the extracted lipid samples, aliquots of 20 μl, corresponding to 3700 cpm, are deposited on silica 60 chromatography plates (MERCK). The following substances are to be classified in the same category as the active substance:

Err1:Expecting ',' delimiter: line 1 column 224 (char 223)

The silica plates are then exposed with films for autoradiography for 15 days (AMERSHAM, Hyperfilm beta max).

The position of the different classes of lipids - polar lipids, cholesterol sulphate, cerebrosides, ceramides 1 and 2, cholesterol and tri- + di-glycerides - is determined using appropriate standards.

The radioactivity of the spots separated and revealed by autoradiography is measured with a thin-film argon-methane radioactivity analyzer (BERTHOLD).

1.5) Processing of data

The data groups (control and treatment groups) are compared by one-factor analysis of variance (ANOVA 1, p< 0.05), followed by a Dunnett test.

2) Results

After one night of incubation in the presence of human skin discs, the test and reference compositions had no significant effect on total epidermal lipid neosynthesis (Table 3.1). However, they significantly altered the proportion of individual epidermal lipids in this totum: EGF at 10 ng/ml decreased cholesterol sulphate neosynthesis by 46% and increased ceramide 2 neosynthesis by 55% (Table 3.2); lactic acid increased ceramide neurosynthesis by 1.59 (Table 3.2); the composition 1.1 increased neurosynthesis by 2.26 and 4.61 respectively, and ceramide factor 1 and neurosynthesis by 5.6 (Table 3.2).It decreases the neosynthesis of tri- and di-glycerides by 73% (Table 3.3);composition 1.2 increases the neosynthesis of cholesterol sulphate by a factor of 1.32, the neosynthesis of ceramides 1 and 2, respectively, by a factor of 2.47 and 2.51, the neosynthesis of cholesterol by a factor of 4.62.It decreases the neosynthesis of tri- and di-glycerides by 77% (Table 3.2);composition 1.3 increases the neosynthesis of cholesterol sulphate by a factor of 1.24;the neosynthesis of ceramides 1 and 2, respectively, by a factor of 1.59 and 3.66; and it decreases the neosynthesis of tri- and neosynthesis of illy-glycerides by a factor of 3.14 and 84% (Table 04).2) The placebo composition decreases tri- and di-glyceride neosynthesis by 59% (Table 3.3.) without causing a significant increase in the various epidermal lipids analysed.

In conclusion, under the experimental conditions used, the compositions 1.1, 1.2, 1.3, and placebo have no significant effect on total epidermal lipid biosynthesis.

They significantly alter the proportion of the different classes of epidermal lipids separated chromatographically in the totum.

They decrease the neosynthesis of tri- and di-glycerides to the benefit of other epidermal lipids.

Composition 1.1 increases cholesterol neosynthesis (without modifying cholesterol sulphate neosynthesis) and ceramide neosynthesis.

Compounds 1.2 and 1.3 increase the neosynthesis of cholesterol sulphate and cholesterol, and the neosynthesis of ceramides.

The placebo composition did not cause a significant increase in the various epidermal lipids analysed.

3) Tables of results

Témoin	EGF 10 ng/ml	Acide lactique	Composition 1.2	Composition 1.3	Composition 1.1	Composition placébo
4183,35	3104,63	1864,31	2479,26	3646,42	873,10	1506,12
4407,89	5043,66	4919,12	3858,70	5255,70	3726,00	4154,88
3691,69	3606,76	4027,67	6571,13	3900,53	3802,63	4429,96
1062,72	4565,02	1076,21	2457,78	3209,16	905,55	2373,94
+/-	+/-	+/-	+/-	+/-	+/-	+/-

Les résultats sont exprimés en cpm/mg d'épiderme. En gras : moyenne et écart type En italique : pourcentage du groupe témoin * : moyenne significativement différente du groupe témoin (p<0,05)

Produit	Lipides polaires	Sulfate cholestérol	de Cérébrosides	Céramide	1 Céramide	2 Cholestérol	Tri- + di-glycérides
Témoin	28,94	6,04	1,89	2,03	2,03	8,23	50,83
	24,96	4,80	2,08	2,67	2,07	5,04	53,76
	31,74	6,26	4,02	2,71	2,15	7,89	45,23
	42,90	5,12	4,44	1,67	1,47	5,61	38,84
	+/-	+/-	+/-	+/-	+/	+/-	+/-
	100	100	100	100	100	100	100
	EGF 10 ng/ml	57,27	2,31	2,87	2,02	3,81	7,07	42,67
		34,42	3,69	3,82	1,41	2,38	9,46	44,82
27,69		3,44	4,77	3,41	2,74	7,86	50,08
33,53		2,57	4,02	4,02	3,05	9,99	42,83
+/-		+/-	+/-	+/-	+/-	+/-	+/-
119		54	125	120	155	128	96
Acide Lactique		49,20	4,07	4,46	2,37	1,70	7,77	33,43
		33,04	4,16	4,54	2,64	3,32	9,72	42,58
	64,49	5,90	6,07	2,94	2,57	8,07	31,95
	53,51	4,25	4,68	2,58	1,44	8,67	24,86
	+/-	+/-	+/-	+/-	+/-	+/-	+/-
	156	83	159	116	117	128	70
	Composition 1.2	24,57	6,89	4,41	2.78	6,86	44,35	10,13
		28,71	8,34	5,91	5,94	3,34	35,04	12,72
33,09		6,86	4,02	4,55	4,79	36,97	9,72
35,78		7,35	7,76	9,20	4,37	34,01	11,52
+/-		+/-	+/-	+/-	+/-	+/-	+/-
4,93		0,69	1,70	2,72	1,48	4,67	1,37
95		132	178	247	251	562	23
Composition 1.3		38,88	6,23	6,23	3,20	8,92	28,63	7,92
	43,70	8,25	4,55	3,51	7,25	24,34	8,41
	37,70	6,88	3,97	3,52	6,69	33,55	7,68
	47,94	6,15	6,13	4,24	5,40	24,30	5,85
	+/-	+/-	+/-	+/-	+/-	+/-	+/-
	131	124	168	159	366	414	16

Les résultats sont exprimés en pourcentage des lipides totaux radiomarqués déposés sur la CCM. En gras : moyenne et écart type En italique : pourcentage du groupe témoin * : moyenne significativement différente du groupe témoin (p<0,05)

Produit	Lipides polaires	Sulfate de cholestérol	Cérébrosides	Céramide 1	Céramide 2	Cholestérol	Tri- + diglycérides
Témoin	28.94	6.04	1.89	2.03	2.03	8.23	50.83
	24,96	4,80	2,08	2,67	2,07	5,04	53,76
	31,74	6,26	4,02	2,71	2,15	7,89	45,23
	42,90	5,12	4,44	1,67	1,47	5,61	38,84
	+/-	+/-	+/-	+/-	+/-	+/-	+/-
	100	100	100	100	100	100	100
	Composition 1.1	37.24	6.43	4.35	5.12	8.38	32.19	16.28
		32,48	4,83	5,45	4,22	7,77	32.51	12.74
31.92		3.81	5.68	5.43	8,06	32.23	10.86
25,87		4,41	4.49	5,75	11,37	38,00	10,11
+/-		+/-	+/-	+/-	+/-	+/-	+/-
99		88	161	226	461	504	26
Composition placébo		73.67	9.27	7.69	2.44	2.05	3.03	18.60
		58.70	11,03	7.60	2,51	3.39	3,71	13,07
	55,90	6,63	3,71	4,21	3.67	8,66	17.20
	63,39	5,69	4,48	4,17	3,35	4,93	27,98
	+/-	+/-	+/-	+/-	+/-	+/-	+/-
	196	147	189	147	161	76	41

Les résultats sont exprimés en pourcentage des lipides totaux radiomarqués déposés sur la CCM. En gras: moyenne et écart type En italique : pourcentage du groupe témoin * : moyenne significativement différente du groupe témoin (p<0,05)

Example 3: composition of a cream for atopic skin

	%
Water	QSP 100
Glycerin	15
Petrolatum	2
Hydrogenated Palm Kernel Oil	5
Caprilic/Capric Triglycerides	5
Cyclomethicone	1
Sucrose Distearate	4
Dextrin	3
1
Squalane	2
Candelilla (Euphorbia Cerifera) Wax	1
Sucrose Stearate	2
Oat (Avena Sativa) Flour	1
Dimethiconol	0,2
Methylparaben	0,4
Propylparaben	0,3
Xanthan Gum	0,2
Ceramide 3	0,2

(1) : Oléodistillat de tournesol-1 de l'exemple 1

Example 4: composition of an oil for atopic skin bath

Sunflower (Helianthus Annuus) Seed Oil	QSP 100
Octyl Cocoate	15
Sweet Almond (Prunus Amygdalus Dulcis) Oil	15
Mineral Oil	1
PEG-6 Isostearate	5
Sunflower (Hellanthus Annuus) seed Oil Unsaponifiables (1)	60
Chamomile (Anthemis Nobilis) Oil	5
Propylene Glycol Dipelargonate	1
Lecithin	1
Laureth-2	0,5
Tocopherol	0,5
Ascorbyl palrnitate	0,06

(1): Oléodistillat de toumesol-1 de l'exemple 1

Err1:Expecting ',' delimiter: line 1 column 312 (char 311) 1) Materials and method 1.1 Objective of the study

Err1:Expecting ',' delimiter: line 1 column 353 (char 352)

1.2 Relevance of the test

Err1:Expecting ',' delimiter: line 1 column 59 (char 58)

1.3 Inclusion criteria

Err1:Expecting ',' delimiter: line 1 column 54 (char 53)

1.4 Population studied

Err1:Expecting ',' delimiter: line 1 column 109 (char 108)

1.5 Application of the rules

Single application: 0.07 ml of product, or 2 μl/cm2, on one or two areas of approximately 35 cm2 delimited at the skin of the right or left leg, randomly selected.

Repeated use: 2 times daily under normal conditions of use for 4 consecutive weeks by the volunteer himself at home, in hemicorps.

1.6 Methodology and methods

Unique application: measurement of electrical capacity with a CorneometerTM (Courage + Khazaka electronic GmbH, Germany) and initial surface lipid levels with the SEBUMETRETM SM 810 PC (Courage and Khazaka) at the areas treated with the product under study (hydration kinetics only) and at the untreated control area (one control area per type of measurement) approximately 1, 2, 3 and 24 hours before, then 1, 2, 3 and 24 hours after application of the products.

Err1:Expecting ',' delimiter: line 1 column 303 (char 302)

1.7 Statistics and other

Instrumental measurements (corneometry and sebometry): ANOVA and multiple comparison test (p < 0,05) for absolute values and differences (Δ Tx ― T0).

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Calculation of the percentage change in the parameters evaluated during the study.

2) Results 2.1 EFFECT on the rate of skin surface lipids after single application (SebumeterTM)

A statistically significant increase in surface lipid levels from baseline and control values was observed approximately 1 and 2 and 3 hours after the first application, reflecting a clear immediate relipidising effect not observed for approximately 24 hours after application (reflecting total absorption of the 1.1 compound, with no residual fat film on the skin surface).

2.2 Effect on the hydration of the upper layers of the epidermis after single and repeated application (corneometerTM)

- After single application (n = 20) A statistically significant increase in electrical capacity is observed from the initial measurements and values at the control zone, approximately 1 and 2, 3 and 24 hours after the first application of the composition 1.1. - After 4 weeks of repeated use (n = 18) There is a statistically significant increase in electrical capacity compared to the original measurements. - What?

+ 0,0%

+ 1,0%

+ 0,5%

+ 2,9%

2.3 Effect on the micro-pressure sewer Err1:Expecting ',' delimiter: line 1 column 78 (char 77)

A statistically significant restructuring of the MicroDepression Network was observed after 4 weeks of applications. - What?

2.4 Clinical evaluation by the head of the study (clinical score of 9 points)

A statistically significant change in the following outcomes was observed after 4 weeks of use: - What?

2.5 Self-assessment by volunteers (analogue visual scale of 10 points)

A statistically significant change in the following outcomes was observed after 4 weeks of use: - What?

3) Conclusion

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Repeated applications, twice daily for 4 consecutive weeks, under normal conditions of use, by a panel of 18 adult female subjects also resulted in: A statistically significant effect on the degree of hydration of the upper layers of the epidermis; a statistically significant restructuring of the microdegenerative network; a statistically significant improvement in the appearance of the skin (dryness, roughness and flaking).

Err1:Expecting ',' delimiter: line 1 column 171 (char 170)

The applications of the composition 1.1 studied were also very well tolerated.

All these results therefore justify the following properties for composition 1.1: Immediate re-lipidising effect,immediate and long-lasting moisturising effect on the upper layers of the epidermis,improvement in the appearance of the skin; and tolerance and efficacy tested under dermatological control.

Claims (7)

1. Use of at least one sunflower oil product chosen from the group consisting of sunflower oil oleodistillates, sunflower oil unsaponifiables, and mixtures thereof, for the preparation of a composition for treating dry skin, skin exposed to actinic rays, notably UV rays, sensitive skin, irritated skin, reactive skin, cutaneous desquamation, pruritus, ichthyosis, acne, xerosis, or atopic dermatitis.
2. Use according to claim 1, characterised in that the sunflower oil unsaponifiables and oleodistillates are chosen from the group consisting of unsaponifiables and oleodistillates rich in tocopherols and/or phytosterols.
3. Use according to claim 1 or 2, characterised in that the composition is for topical application.
4. Use according to claim 1 or 2, characterised in that the composition is for oral administration.
5. Non-therapeutic cosmetic use of at least one sunflower oil product chosen from the group consisting of sunflower oil oleodistillates, sunflower oil unsaponifiables, and mixtures thereof, for treating disorders associated with ageing of the skin, neighbouring mucosa and/or skin appendages, for treating disorders associated with drying of the skin, neighbouring mucosa and/or skin appendages, or for treating disorders of the skin, neighbouring mucosa and/or skin appendages resulting from exposure to actinic rays, notably UV rays.
6. Cosmetic use according to claim 5, characterised in that the sunflower oil product is for topical application.
7. Cosmetic use according to claim 5, characterised in that the sunflower oil product is for oral administration.