EP4577203A1 - Méthodes pour améliorer l'aspect de la peau souffrant d'eczéma - Google Patents

Méthodes pour améliorer l'aspect de la peau souffrant d'eczéma

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Publication number
EP4577203A1
EP4577203A1 EP23764998.3A EP23764998A EP4577203A1 EP 4577203 A1 EP4577203 A1 EP 4577203A1 EP 23764998 A EP23764998 A EP 23764998A EP 4577203 A1 EP4577203 A1 EP 4577203A1
Authority
EP
European Patent Office
Prior art keywords
composition
oat
skin
eczema
total weight
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23764998.3A
Other languages
German (de)
English (en)
Inventor
Katie SPISAK
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kenvue Brands LLC
Original Assignee
Kenvue Brands LLC
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Filing date
Publication date
Application filed by Kenvue Brands LLC filed Critical Kenvue Brands LLC
Publication of EP4577203A1 publication Critical patent/EP4577203A1/fr
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/88—Liliopsida (monocotyledons)
    • A61K36/899—Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/31—Hydrocarbons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
    • A61K8/365—Hydroxycarboxylic acids; Ketocarboxylic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/58—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing atoms other than carbon, hydrogen, halogen, oxygen, nitrogen, sulfur or phosphorus
    • A61K8/585—Organosilicon compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/96—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution
    • A61K8/97—Cosmetics or similar toiletry preparations characterised by the composition containing materials, or derivatives thereof of undetermined constitution from algae, fungi, lichens or plants; from derivatives thereof
    • A61K8/9783—Angiosperms [Magnoliophyta]
    • A61K8/9794—Liliopsida [monocotyledons]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin

Definitions

  • Lubricants are effective in keeping the skin hydrated and repairing the skin barrier.
  • the cosmetic acceptance of these types of formulations may be poor which is reflected in a lower compliance among the atopic dermatitis patients.
  • this approach is often not sufficient by itself.
  • Corticosteroids on the other hand are powerful medications but are known to induce side effects, some of which might be severe in case of long term usage.
  • antihistamine can be used to treat itch associated with atopic dermatitis, they can cause sleepiness and may not help in all cases of atopic dermatitis.
  • the use of antibiotics is controversial due to the raising occurrence of bacterial resistance.
  • a treatment will ideally address the visual appearance of skin afflicted with eczema, and/or otherwise provide other sensorial benefits, such as a cooling sensation.
  • traditional ingredients are often too harsh for use on the sensitive skin of individuals with eczema.
  • compositions which are suitable for use on eczematic skin and can address one or more of the concerns above.
  • compositions suitable for skin afflicted with eczema comprising: a. an alpha hydroxy acid; b. a volatile emollient; and c. a processed oat ingredient.
  • the alpha hydroxy acid is selected from the group consisting of glycolic acid, malic acid, tartaric acid, pyuric acid, mandelic acid, lactic acid, and combinations thereof. In some embodiments, the alpha hydroxy acid is present in an amount ranging from about 0.01 wt.% to about 5 wt.% by total weight of the composition.
  • the volatile emollient is selected from the group consisting of cyclopentasiloxane, dimethicone, isoparaffin cuts (C9-C16), ethyl trisiloxane, trisiloxane and caprylyl methicone, isododecane, and combinations thereof.
  • the volatile emollient is present in an amount ranging from about 0.01 wt.% to about 12 wt.% by total weight of the composition.
  • the processed oat ingredient is selected from the group consisting of oat extract, colloidal oatmeal, oat oil, fermented oat, avenanthramides, beta-glucan, modified oat grain material, and combinations thereof. In some embodiments, the processed oat ingredient is present in an amount ranging from about 0.01 wt.% to about 30 wt.% by total weight of the composition.
  • the composition further comprises a dermatologically-acceptable ingredient selected from the group consisting of viscosity increasers, humectants, skin conditioners, emulsifiers and combinations thereof.
  • the composition has a pH of from about 4.5 to about 5.5.
  • the composition is in the form of a lotion, gel or cream product.
  • Another aspect of the invention pertains to a composition suitable for skin afflicted with eczema, the composition comprising: a. lactic acid; b. isododecane; and c. a processed oat ingredient selected from the group consisting of oat extract, colloidal oatmeal, oat oil and combinations thereof.
  • the composition comprises: a. from about 0.01 wt.% to about 3 wt.% lactic acid; b. from about 0.01 wt.% to about 4 wt.% isododecane; and c. from about 0.01 wt.% to about 6 wt.% combined of oat extract, colloidal oatmeal, and oat oil.
  • Another aspect of the invention pertains to a method of treating eczema, the method comprising topically applying to skin afflicted with eczema any of the compositions described herein.
  • the skin afflicted with eczema comprises mild to moderate eczema.
  • Another aspect of the invention pertains to a method of improving the appearance of skin afflicted with eczema, the method comprising topically applying to skin afflicted with eczema a composition comprising lactic acid.
  • the lactic acid is present in an amount ranging from about 0.01 wt.% to about 5 wt.% by total weight of the composition.
  • the skin afflicted with eczema comprises mild to moderate eczema.
  • the composition is applied to a lesional area.
  • the composition is applied to the face or body.
  • the composition is applied once or twice per day.
  • the composition further comprises a dermatologically-acceptable ingredient selected from the group consisting of thickeners, additional emollients, humectants, skin conditioners, emulsifiers and combinations thereof.
  • a dermatologically-acceptable ingredient selected from the group consisting of thickeners, additional emollients, humectants, skin conditioners, emulsifiers and combinations thereof.
  • the composition is in the form of a lotion, gel or cream product.
  • Another aspect of the invention pertains to a method of providing a cooling sensation to skin afflicted with eczema, the method comprising topically applying to skin afflicted with eczema a composition comprising isododecane.
  • the isododecane is present in the composition in an amount ranging from about 0.01 wt.% to about 12 wt.% by total weight of the composition.
  • the skin afflicted with eczema comprises mild to moderate eczema.
  • the composition is applied to a lesional area.
  • the composition is applied to the face or body. In one or more embodiments, the composition is applied once or twice per day.
  • the lesional area exhibits a symptom selected from the group consisting of erythema, pruritus, exudation, excoriation, lichenification, dryness, tactile roughness, abnormal skin tone, burning, stinging, and combinations thereof.
  • the composition further comprises an alpha hydroxy acid.
  • the alpha hydroxy acid is present in an amount ranging from about 0.01 wt.% to about 5 wt.% by total weight of the composition.
  • the volatile emollient is selected from the group consisting of cyclopentasiloxane, dimethicone, isoparaffin cuts (C9-C16), ethyl trisiloxane, trisiloxane and caprylyl methicone, isododecane, and combinations thereof.
  • the composition further comprises a processed oat ingredient.
  • the processed oat ingredient is selected from the group consisting of oat extract, colloidal oatmeal, oat oil, fermented oat, avenanthramides, beta-glucan, modified oat grain material, and combinations thereof.
  • the processed oat ingredient is present in an amount ranging from about 0.01 wt.% to about 30 wt.% by total weight of the composition. In one or more embodiments, the cooling sensation persists for at least 5 minutes. In some embodiments, the composition is in the form of a lotion, gel or cream product.
  • FIG. 3 is a thermal image of the same skin as in the preceding figures at 5 mins post-treatment
  • FIG. 5 is a thermal image of the same skin as in the preceding figures at 15 mins post-treatment
  • FIG. 11 is a chart of alpha-diversity: genus level Chaol richness
  • FIG. 12 is a chart of alpha-diversity: genus level Shannon diversity
  • FIG. 13 is a chart of alpha-diversity: genus level Simpson diversity
  • FIG. 14 is a chart of alpha-diversity: species level Chaol richness
  • FIG. 15 is a chart of alpha-diversity: species level Shannon diversity
  • FIG. 16 is a chart of alpha-diversity: species level Simpson diversity
  • FIG. 17 is a chart of in vitro bacteria competition colloidal oat flour, oat extract, and glycerin;
  • FIG. 18 is a chart of in vitro bacteria competition colloidal oat flour, oat extract, oat oil, lactic acid, and combination treatments.
  • cosmetically acceptable means that the ingredients the term describes are suitable for use in contact with tissues (e.g., the skin or hair) without undue toxicity, incompatibility, instability, irritation, allergic response, or the like.
  • composition suitable for skin afflicted with eczema the composition comprising: (a) an alpha hydroxy acid; (b) a volatile emollient; and (c) a processed oat ingredient. It has been surprisingly discovered that such compositions are able to improve the cosmetic appearance of skin afflicted with eczema, skin barrier properties and hydration.
  • another aspect of the invention pertains to a method of improving the appearance of skin afflicted with eczema, the method comprising applying to skin afflicted with eczema a composition comprising lactic acid.
  • the term “improving the appearance of skin afflicted with eczema” refers to improvement in one or more of the visual symptoms of skin afflicted with eczema (e.g., dryness bumps, crusting scaliness, etc.), particularly in skin tone.
  • another aspect of the invention pertains to a method of providing a cooling sensation to skin afflicted with eczema, the method comprising applying to skin afflicted with eczema a composition comprising isododecane.
  • Alpha hydroxy acids are compounds which contain a carboxylic acid that is substituted with a hydroxyl group on the adjacent carbon atom.
  • alpha hydroxy acids include, but are not limited to, glycolic acid, lactic acid, malic acid, tartaric acid, pyuric acid, mandelic acid, or any combination of any of the foregoing.
  • the alpha hydroxy acid comprises lactic acid. Suitability of the alpha hydroxy acid (especially lactic acid) is surprising, as such acids are generally thought of as being too harsh for skin afflicted with eczema.
  • the alpha hydroxy acid may be present in amounts ranging from about 0.01, 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, or 5 to about 1.0, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, or 5 wt.% of the total composition.
  • the alpha hydroxy acid is present in an amount ranging from about 0.01 wt.% to about 5 wt.% by total weight of the composition.
  • the alpha hydroxy acid is present in an amount ranging from about 0.1 wt.% to about 4 wt.% by total weight of the composition.
  • the alpha hydroxy acid is present in an amount ranging from about 0.5 wt.% to about 2 wt.% by total weight of the composition. In some embodiments, the alpha hydroxy acid is present in an amount ranging from about 0.5 wt.% to about 1.5 wt.% by total weight of the composition. In one or more embodiments, the alpha hydroxy acid is present in an amount of about 0.75 wt.% to about 1.5 wt.% by total weight of the composition. In some embodiments, the alpha hydroxy acid is present in an amount of about 1 wt.% to about 1.5 wt.% by total weight of the composition.
  • the alpha hydroxy acid comprises lactic acid.
  • the lactic acid may be present in amounts ranging from about 0.01, 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, or 5 to about 1.0, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, or 5 wt.% of the total composition.
  • the lactic acid is present in an amount ranging from about 0.01 wt.% to about 5 wt.% by total weight of the composition.
  • the lactic acid is present in an amount ranging from about 0.1 wt.% to about 4 wt.% by total weight of the composition. In one or more embodiments, the lactic acid is present in an amount ranging from about 0.5 wt.% to about 2 wt.% by total weight of the composition. In some embodiments, the lactic acid is present in an amount ranging from about 0.5 wt.% to about 1.5 wt.% by total weight of the composition. In one or more embodiments, the lactic acid is present in an amount of about 0.75 wt.% to about 1.5 wt.% by total weight of the composition. In some embodiments, the lactic acid is present in an amount of about 1 wt.% to about 1.5 wt.% by total weight of the composition.
  • a “volatile emollient” refers to an emollient that has a flash point within 15 °C of the temperature of skin, and therefore do not persist on the skin after application.
  • the volatile emollient may act as a cooling agent to provide a cooling sensation to the user’s skin and will readily vaporize.
  • the volatile emollient provides a cooling sensation on the skin solely due to evaporation of the ingredient from skin. It is thought there is a higher efficacy of cooling when it takes longer for ingredient to evaporate.
  • the composition may include a volatile emollient, such as, isododecane.
  • volatile emollients may include cyclopentasiloxane, dimethicone, isoparaffin cuts (C9-C16), ethyl trisiloxane, trisiloxane and caprylyl methicone.
  • the volatile emollient comprises isododecane.
  • the volatile emollient may be present in amounts ranging from about 0.01, 0.05, 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, or 5 to about 5, 5.5, 6, 6.5, 7, 8, 9, 10, 11 or 12 wt.% of the total composition. In one or more embodiments, the volatile emollient is present in an amount ranging from about 0.1 wt.% to about 10 wt.% by total weight of the composition. In some embodiments, the volatile emollient is present in an amount ranging from about 0.1 wt.% to about 5 wt.% by total weight of the composition.
  • the volatile emollient is present in an amount ranging from about 0.5 wt.% to about 5 wt.% by total weight of the composition. In some embodiments, the volatile emollient is present in an amount ranging from about 0.5 wt.% to about 4 wt.% by total weight of the composition. In one or more embodiments, the volatile emollient is present in an amount ranging from about 0.5 wt.% to about 3 wt.% by total weight of the composition. In some embodiments, the volatile emollient is present in an amount ranging from about 1 wt.% to about 3 wt.% by total weight of the composition.
  • each of the following materials were added to the vessel with continuous mixing and maintaining the temperature at 75-80°C: ceteryl olivate, sorbitan olivate(Olivem 1000), cetyl alcohol, Euphorbia Cerifera (Candelilla) wax, hydrogenated vegetable oil, vegetable oil(Cegesoft VP), Butyrospermum Parkii (Shea) butter, isopropyl palmitate, isododecane, and Avena Sativa (Oat) Kernel oil.
  • Continuous mixing continued until the batch was uniform, then the temperature was cooled to 68-75°C for a minimum of 5 minutes. The temperature was then allowed to begin cooling while adding the other half of the glycerin.
  • a single-center, monadic clinical study was conducted to evaluate the efficacy and perceived benefits in itch and tolerability of a test composition when used on an eczema target lesion of subjects with mild to moderate eczema.
  • the study was run by a Principal investigator, who was a board certified dermatologist.
  • the study was inclusive of a variety of demographics including age, sex, ethnicity, race, skin type, and skin tone. Exclusion criteria included having a skin condition that may interfere with the outcomes of the study such as, severe eczema, psoriasis, rosacea, rashes, many and/or severe excoriations, etc.; using Class I-III topical corticosteroids or systemic medications that may have a direct or indirect effect on eczema; or having known allergies or adverse reactions to common skin care ingredients.
  • Enrollment criteria included subjects having mild to moderate eczema severity rating (Rajka and Langeland Severity Index) at visit 1, having at least one targeted eczema lesional area at visit 1 with a score of 5 - 12 on the Atopic Dermatitis Severity Index (ADSI) , with mild or moderate, and erythema. 35 subjects completed study participation.
  • ADSI Atopic Dermatitis Severity Index
  • Subjects were also instructed to wash and remove all topical products on eczema lesion area at least 2-3 hours prior to each visit for evaluations. During the course of the study, subjects applied the test composition on the selected target lesion at least twice per day (once in the morning and once in the evening), as directed. Subjects performed the first application of the test composition on the target lesion on-site after completion of baseline evaluations.
  • Clinical evaluations were conducted at visit 1 (baseline), visit 2 (day 3), visit 3 (week 1/day 7), and visit 4 (week 2/day 14).
  • Principal investigator (PI) evaluated the efficacy of the test composition by grading the various endpoints discussed in the subjects’ eczema lesions using Atopic Dermatitis Severity Index (ADSI). The reported ADSI score was the sum of the individual scores.
  • the subject’s target lesion was evaluated for dryness, tactile roughness, and skin tone of lesion compared to normal overall skin tone.
  • the PI assessed tolerance of subject’s target lesion for overall irritation and asked each subject to rate the degree of burning/stinging sensation on the target eczema lesion. See Tables 2-6 for scoring criteria.
  • Test composition prepared as described above, and D.I. water were self-applied by the subject separately on the volar forearm.
  • the cooling effect of the test composition was compared with D.I. water as the control.
  • a FLIR thermal camera Teledyne FLIR, Thousand Oaks, CA was used to capture the skin surface temperature at baseline, immediately post-application, 5 min post application, 10 min post application, and 15 min post application. The displayed temperature range was adjusted to accommodate subject’s baseline skin surface temperature.
  • Subject was then instructed to apply both the treatment and control as they normally would with personal care products at the designated sites.
  • the subjects were allowed to spread and rub in the product larger than the marked site, but were instructed to avoid overlapping the products on their skin.
  • the experiment was repeated on 5 subjects.
  • FIGS. 1-5 Representative thermal images in grayscale are shown in FIGS. 1-5 for baseline, immediately postapplication, 5, 10, and 15 minutes post-application, respectively.
  • the spot labeled 1 was the control while the spot labeled 2 was the test composition.
  • the light gray circular spots marked by 1 and 2 show the cooling effect at 5-10 minutes, however at 15 minutes only spot 2, the test composition, continues to show the cooling effect. There was variation in the duration of the cooling effect for both the test composition and the control, in general the test composition had longer lasting cooling than the control.
  • Example 5 Topical Cream and Gel Cream with Isododecane Clinical Study in Individuals Not Having Eczema (Comparative)
  • a topical gel cream composition (Example 5-1) was made having the following ingredients, as shown in Table 9.
  • Germazide C Commercially available as Germazide C from the BASF Corporation
  • Example 5-1 The following mixing procedure may be used to prepare Example 5-1: a) The purified water is added to a suitable vessel and the colloidal oat flower is added while mixing b) The citric acid and lidocaine USP are added while mixing and mixed until dissolved c) The carbomer is added while mixing slowly until all clumps are dissolved d) The mixture is heated until 75-80°C e) The caprylyl glycol and chlorphenesin are added while mixing and mixed until uniform.
  • a topical cream composition (Example 5-2) was made having the following ingredients, as shown in Table 10. TABLE 10:
  • Germazide C Commercially available as Germazide C from the BASF Corporation
  • the following mixing procedure may be used to prepare the cream of this example: a) The purified water is added to a suitable vessel and the colloidal oat flower is added while mixing b) The citric acid and lidocaine USP are added while mixing and mixed until dissolved c) The carbomer is added while mixing slowly until all clumps are dissolved d) The mixture is heated until 75-80°C e) The caprylyl glycol and chlorphenesin are added while mixing and mixed until uniform.
  • HUT home use test
  • the consumers were instructed to use the product within the first two days of receiving it and then at least once a week as needed after that, over the following two weeks. The consumers were further instructed to abstain from using other pain-relieving treatments during the two- week period.
  • the consumers provided feedback via an online survey at three time points: 1) after first use, 2) after one week of use, and 3) after two weeks of use.
  • Example 5-1 may be referred to as a “soothing gel cream” incorporating, for example, ginger and Example 5-2 may be referred to as a “calming cream” incorporating a suitable calming fragrance, for example, lavender.
  • the objective of the human use study was to generate support for potential consumer perceptual claims centered around a consumers’ experience with the product. For example, an objective was to understand the consumers’ experience with regard to product absorption, discreetness and feel on the skin.
  • test statement may be a question that is answered or a statement that is agreed or disagreed with at least once by the consumer during the duration of the HUT.
  • the following test statements may relate to the consumers’ experience with regard to product absorption: is fast absorbing, instantly absorbs into the skin, is non-greasy, and/or doesn’t leave my skin shiny.
  • the following test statements may relate to the consumers’ experience with regard to “discreetness:” is lightweight, does not have a harsh smell/odor, has no unpleasant smell/odor, is non-sticky, is non-greasy, doesn’t leave my skin shiny, has a pleasant smell.
  • test statements may relate to the consumers’ experience with regard to product feel: is lightweight, is non-sticky, is non-greasy, instantly moisturizes, leaves my skin feeling silky, instantly cools, feels like it is working right away and/or instantly numbs.
  • the test statements of instantly cools, feels like it is working right away and/or instantly numbs may indicate pain relief.
  • the percentage of subjects reporting a cooling effect is 61% for 5- 1 and 64% for 5-2.
  • this study included subjects who did not have eczema.
  • isododecane does not necessarily provide a cooling effect that is perceived at the same rate as in those having eczema, even when present in amounts as high as 4% and 8%, which are much higher than the 2% present in the formulation of Example 1.
  • Example 6 Microbiome clinical study A clinical study was conducted according to the methods described in Example 2. At Visit 1 (baseline), Visit 2 (day 3), Visit 3 (day 7), and Visit 4 (day 14), surface skin microbiome was collected from each subject’s target lesion. Swabbing was conducted within a 4 cm X 4 cm area of skin on the identified target lesion. A sterile swab was dipped into an aliquot of 0.85% sterile saline and wrung of excess liquid by pressing it against the inner wall of the saline tube. The lateral edge of the swab was rubbed across the entire defined area while being rotated between the thumb and forefinger for 60 seconds.
  • the rotating swab was rubbed back and forth in a crosswise manner in the defined area in the same fashion for each subject to maintain consistency.
  • the head of each swab was placed into a sterile microcentrifuge tube and aseptically cut from the handle before the lid was closed.
  • the tube was labeled with the protocol ID, subject ID, and visit number. Post-baseline swabs were performed on the same location as baseline.
  • a control swab was taken on each day a subject was sampled, after the subject swabs were collected.
  • a sterile swab was dipped into an aliquot of 0.85% sterile saline and wrung of excess liquid by pressing it against the inner wall of the saline tube. Without touching the polyester tip to any surface, the head of the swab was placed into a sterile microcentrifuge tube and aseptically cut from the handle before the lid was closed.
  • the tube was labeled with the protocol number, date, and “Micro Control” (or equivalent identification).
  • Swabs from each subject and control swabs were frozen at -20 °C until shipment on dry ice to a Sponsor-appointed external laboratory (CosmosID Inc., Germantown, MD) for DNA extraction and analysis to determine the effect of the IP on the skin microflora.
  • a Sponsor-appointed external laboratory CosmosID Inc., Germantown, MD
  • 16S samples were utilized in the analysis. All figures were generated using 16S OUT analysis from the CosmosID Hub, and adjusted by 16S qPCR abundances with control abundances subtracted from all other samples.
  • Taxonomic comparative statistical analysis was performed by the external laboratory, including qPCR Abundance, Relative Abundance, Alpha Diversity, and Beta Diversity.
  • qPCR Abundance is the mean abundance per group and scaled abundance for each sample.
  • Relative abundance is the mean abundance of top bacterial species per group.
  • Alpha diversity is the number and abundance of taxa and the differences per group.
  • Beta diversity is the dissimilarity of the overall microbial communities and shows if the cohorts are significantly different.
  • Staphylococcus aureus S. aureus
  • Staphylococcus epidermidis S. epidermidis
  • Mean abundance per group and scaled abundance for each sample were calculated.
  • Stacked Bar figures were generated using phylum, genus, and specieslevel filtered matrices from CosmosID. Stacked bar figures for each group were generated using the R package ggpubr.
  • Staphylococcus aureus and Staphylococcus epidermidis copy number by cohort are shown in FIGS. 6 and 7 respectively, while the ratio of average Staphylococcus epidermidis to average Staphylococcus aureus copy number by cohort are shown in FIG. 8.
  • S. qPCR copy number between baseline and day 14.
  • S. epidermidis qPCR copy number between baseline and day 14.
  • the ratio of S. epidermidis to S. aureus increased between baseline and day 14.
  • Genus level relative abundance and species level relative abundance are shown in FIGS. 9 and 10, respectively. There was a visual increase in Staphylococcus genus between baseline and day 14 relative to other genus. At the species level, there was an increase in S. epidermidis between baseline and day 14; and a slight decrease in S. aureus between baseline and day 14, again relative to the level of other species present. An increase was observed in other commensals, including an unexpected increase in S. hominis relative abundance between baseline and Day 14.
  • Alpha diversity boxplots were calculated from the genus and species level abundance score matrices respectively, from CosmosID analysis. Chao, Simpson, and Shannon alpha diversity metrics were calculated in R using the R package Vegan. Wilcoxon Rank- Sum tests were performed between groups using the R package ggsignif. Boxplots with overlaid significance in p-value format were generated using the R package ggplot2.
  • a significant decrease across all alpha diversity indices (Chaol FIGS. 11 and 14, Shannon FIGS. 12 and 15, Simpson FIGS. 13 and 16) between baseline and day 14 at both the genus and species level.
  • Alpha diversity between day 7 and day 14 showed trending as a potential increase: significant increase between day 7 and day 14 observed in species-level Shannon Diversity and Simpson Diversity analyses. Generally, it is thought that increasing diversity is preferred, and thus seeing an increase is surprising given the very positive clinical results of Example above.
  • Beta Diversity Principal Coordinate Analyses were calculated from phylum, genus, and specieslevel filtered matrices from CosmosID. Bray-Curtis diversity was calculated in R using the R package vegan with the functions vegdist, and PCoA tables were generated using ape’s function pcoa. PERMANOVA tests for each distance matrix were generated using vegan’s function adonis2. Plots were visualized using the R package ggpubr. The PERMANOVA results are shown in Table 12 and the Pairwise PERMANOVA results are shown in Table 13 below, a significant change in beta diversity between baseline and day 14 was observed which indicated significantly different microbial communities.
  • FIG. 18 shows the bacteria competition assay results for oat extract, oat flour, oat oil, lactic acid, and combinations as described in Table 15.
  • 2% oat flour and 0.5% oat oil each significantly promoted the growth of S. epidermidis over S. aureus and versus untreated.
  • 1 % Oat Extract + 2% Oat Flour significantly promoted the growth of S. epidermidis over S. aureus and versus untreated.
  • 2% Colloidal Oat Flour + 1% Oat Extract + 0.5% Oat Oil also significantly promoted the growth of S. epidermidis over S. aureus and versus untreated.

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Abstract

L'invention concerne une méthode pour améliorer l'aspect de la peau souffrant d'eczéma, la méthode consistant à administrer par application topique sur la peau souffrant d'eczéma une composition comprenant de l'acide lactique, éventuellement en combinaison avec un émollient volatil et/ou un ingrédient à base d'avoine transformé.
EP23764998.3A 2022-08-23 2023-08-23 Méthodes pour améliorer l'aspect de la peau souffrant d'eczéma Pending EP4577203A1 (fr)

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PCT/IB2023/058386 WO2024042475A1 (fr) 2022-08-23 2023-08-23 Méthodes pour améliorer l'aspect de la peau souffrant d'eczéma

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US5814662A (en) * 1996-11-01 1998-09-29 Chesebrough-Pond's Usa Co., Division Of Conopco, Inc. Skin treatment with alpha-hydroxycarboxylic acids of mixed chain length
MX2022010964A (es) * 2020-03-06 2022-10-18 Symrise Ag Composicion que comprende una avenantramida o un analogo de la misma con estabilidad mejorada.
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