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WO1996027365A1 - Composition anti-acneique douce - Google Patents

Composition anti-acneique douce Download PDF

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Publication number
WO1996027365A1
WO1996027365A1 PCT/US1996/002938 US9602938W WO9627365A1 WO 1996027365 A1 WO1996027365 A1 WO 1996027365A1 US 9602938 W US9602938 W US 9602938W WO 9627365 A1 WO9627365 A1 WO 9627365A1
Authority
WO
WIPO (PCT)
Prior art keywords
acne
lactic acid
salicylic acid
formulation
steareth
Prior art date
Application number
PCT/US1996/002938
Other languages
English (en)
Inventor
Mark S. Garrison
John A. Duffy
Janice J. Teal
Original Assignee
Avon Products, Inc.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from US08/397,794 external-priority patent/US5515287A/en
Application filed by Avon Products, Inc. filed Critical Avon Products, Inc.
Priority to BR9605917A priority Critical patent/BR9605917A/pt
Priority to JP8526992A priority patent/JPH09511769A/ja
Priority to AU53018/96A priority patent/AU5301896A/en
Priority to EP96909570A priority patent/EP0756479A4/fr
Publication of WO1996027365A1 publication Critical patent/WO1996027365A1/fr

Links

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
    • A61K31/60—Salicylic acid; Derivatives thereof
    • 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
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/36—Carboxylic acids; Salts or anhydrides thereof
    • A61K8/368—Carboxylic acids; Salts or anhydrides thereof with carboxyl groups directly bound to carbon atoms of aromatic rings
    • 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
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin

Definitions

  • the present invention relates to compositions for topical anti-acne treatment. More particularly, the invention comprises salicylic acid and lactic acid adjusted to a selected pH and combined with a suitable vehicle for treating adult acne and sensitive skin conditions such as rosacea complicated with acne.
  • Rosacea complicated with acne is difficult to treat because of the tendency for hypersensitivity and side effects in this group, particularly when known alcoholic solutions, lotions and gels are applied to an individual's skin.
  • Irritant folliculiti ⁇ caused by epithelial irritations, is another sensitive skin condition which manifests as erythematous papules and follicular pustules. Recurrent episodes of irritant folliculitis are sometimes misdiagnosed as common acne and treated with physical abrasives and exfoliants which traumatize and aggravate the original condition.
  • U.S. Patent No. 4,800,197 describes a combination of salicylic acid and an anionic taurate surfactant, specifically sodium methyl cocoyl taurate or sodium methyl oleoyl taurate.
  • U.S. Patent No. 5,296,476 describes the specific use of salicylic acid in combination with calcium citrate. Again, these treatment modalities are designed 4 for aggressive, physical cleansing, which assumes that the individual indicators are normal, young and oily skin.
  • salicylic acid tend to aggravate the relatively dry adult acne, and they are particularly unsuitable for those with sensitive skin conditions such as irritant folliculitis.
  • Known salicylic acid preparations are also poorly tolerated in patients suffering from acne complexed with rosacea.
  • lactic acid for teenage problem skin. See, for example, U.S. Patent Nos. 3,879,537, 4,234,599, 4,363,815 and 4,380,549 which generally describe the use of alpha-hydroxy acids such as lactic and citric acids for titrating pH in antibiotic preparations. These antibiotic therapies assume that teen acne has predominant etiological ties to opportunistic bacterial infections like those found in acne vulgaris.
  • U.S. Patent No. 4,507,319 describes the use of lactic acid for adjusting pH in a composition comprising derivatives of 2-hydroxy-octanoic acid or 2-keto-octanoic acid; and
  • U.S. Patent No. 4,330,531 describes a germ killing composition containing lactic acid which produces chlorine dioxide gas for antibacterial effects on acne vulgaris.
  • U.S. Patent No. 3,806,593 discloses the use of esters of lactic acid; and U.S. Patent No. 4,540,567 describes the use of lactate esters, preferably ethyl lactate.
  • U.S. Patent Nos. 4,613,592 and 4,772,592 also refer to lactate esters in compositions which have silicone oil and a ⁇ -C ⁇ alkanol.
  • a further object of the present invention is to provide a composition containing a selected range of lactic acid which has a synergistic effect with a selected range of salicylic acid for raising the tolerance levels of sensitive skin to both ingredients, while providing the therapeutic benefits of the two ingredients.
  • the present invention is directed to a mild, topical formulation for treating adult acne and sensitive skin conditions complicated with acne, which comprises about 0.05 to about 5.0% salicylic acid; about 0.5 to about 15.0% lactic acid; sufficient pH adjustor to maintain pH in the range of about 3.8 to about 4.5; and a vehicle which maintains the active ingredient levels, desired pH and mildness.
  • a lotion embodiment may have about 6.5% propylene glycol dicaprylate/dicaprate; about 6.0% lactic acid; about 5.0% glycerin; about 3.0% ammonium hydroxide; about 2.0% Peg 40 Stearate; about 1.5% Steareth-2; about 0.6% hydroxyethyl cellulose; about 0.6% xanthan gum; about 0.5% salicylic acid; about 0.2% methylparaben; about 0.2% disodium EDTA; about 0.2% vitamin-E acetate and about 0.3% natural extracts from apple, grape, mango, orange and geranium.
  • One inventive composition includes salicylic acid and lactic acid adjusted to selected pH ranges and mixed in a suitable vehicle such as lotions, creams, gels or other carriers which maintain the active ingredient levels, desired pH and inherent mildness.
  • a suitable vehicle such as lotions, creams, gels or other carriers which maintain the active ingredient levels, desired pH and inherent mildness.
  • the general and preferred ranges in the following examples are expressed as weight percents.
  • Salicylic Acid 0.05-5.0% 0.5-2.0%
  • Lactic Acid 0.5-15.0% 5.0-10.0% Glycerin 0.1-10.0% 0.5-6.0%
  • Peg 40 Stearate 0.5-5.0% 1.8-4.0%
  • Methylparaben 0.1-0.3% 0.20-0.25%
  • glycerin acts as a humectant and moisturizer
  • propylene glycol dicaprylate/ dicaprate is used as an emollient/moistur ⁇ izer
  • Peg-40 stearate and Steareth-2 act as the primary and secondary emulsifiers, respectively
  • xanthan gum and hydroxyethyl cellulose are used for thickening
  • disodium EDTA acts as a chelator to sequester any discoloration causing metal ions
  • methylparaben is used as a preservative.
  • Ammonium hydroxide is used to partially neutralize the lactic and salicylic acids and raise the pH to its required levels.
  • Other suitable pH adjustors include sodium hydroxide, potassium hydroxide and triethanolamine.
  • Salicylic Acid 0.05-5.0% 0.5-2.0% Lactic Acid 0.5-15.0% 5.0-10.0% Glycerin 0.1-5.0% 0.5-4.0%
  • Vitamin E Acetate 0.05-0.2% 0.1-0.2%
  • glycerin, propylene glycol dicaprylate/dicaprate, disodium EDTA and ammonium hydroxide perform similar functions described for the lotion embodiment.
  • Steareth-20 and Steareth-2 act as the primary and secondary emulsifiers, respectively; cetyl alcohol, glyceryl monostearate, xanthan gum and hydroxy ⁇ ethyl cellulose are all used for thickening; and imidazol ⁇ idinyl urea is used as a preservative.
  • Salicylic Acid 0.05-4.0% 0.5-2.0% Lactic Acid 0.5-12.0% 4.0-9.0% Disodium EDTA 0.05-0.25% 0.15-0.20% Propylene Glycol 0.5-9.0% 2.0-6.0% Hydroxyethyl Cellulose 0.3-2.0% 0.4-1.5% Botanical Extracts 0.1-2.0% 0.2-1.5% Methylparaben 0.1-0.3% 0.20-0.25%
  • disodium EDTA, hydroxyethyl cellulose, methylparaben and ammonium hydroxide perform the same or similar functions disclosed for the lotion and cream embodiments.
  • Propylene glycol acts as a humectant and botanical extracts (such as chamomile extract) contributes to gentleness.
  • Glycerin was next added (for lotion and cream embodiments) and mixed continuously for 10-15 minutes. Hydroxyethylcellulose and other thickeners were then slowly sprinkled into the mixture and the sweep was disengaged. The resulting batch was milled (an equivalent vigorous high shear type of mixing is equally effective) for about one hour until a uniform consistency was achieved. Sweep mixing was then resumed and any entrapped air was allowed to rise in this first phase. The temperature was maintained in the first tank at about 160- 165°F.
  • the oil phase plus emulsifiers were heated at 170-175°F and mixed to a uniform consistency.
  • the ingredients in this step were propylene glycol dicaprylate/dicaprate, methylparaben, Steareth-2 and Peg 40 stearate; in the cream, the ingredients comprised propylene glycol dicaprylate/ dicaprate, Steareth-20 and Steareth-2; and in the gel, the ingredients included propylene glycol and methylparaben.
  • the resulting mixture in the second tank) was put through a 200 micron strainer and subsequently added to the first tank containing the first phase.
  • the first phase (in the first tank) was continuously milled during transfer and the resulting batch was further milled for about five minutes after the transfer operation was complete. Following milling, the batch was sweep- mixed slowly for about 10 minutes and allowed to cool to 90-95°F. Slow mixing was continued and other ingredients such as vitamins, botanicals, additional emollients and oils, to suit the particular target product variations, were added. Fragrances were next added.
  • additional ingredients can be introduced in this concluding step or earlier to create other variations which are covered by the scope of this disclosure.
  • the study design included an eight week facial use test, with periodic telephone callback interviews. This quantitative study was fielded in five geographically dispersed locations, for a total of 200 women, with 40 per location. All raw data was processed through statistical analysis using the SAS statistical package.
  • the study was a baseline controlled six month test, with evaluations of facial skin occurring at 4, 9, 12, 18 and 24 weeks.
  • the product's effectiveness was principally evaluated by clinical grades from attending dermatolog ⁇ ists. Panelists returned to the study site every two weeks for a compliance check.
  • Fitzpatrick scale Skin Types I, II or III. A recent history of acne breakout or similar skin disorders was also required. Each participant was examined by a physician to confirm the existence of one or more of the following conditions.
  • Follicular papules small pin-point sized raised bumps associated with irritation of the follicles 2.
  • Papules relatively large red inflammatory lesions
  • Blackheads - a specific type of clogged pore which is covered with a black "cap” and is slightly raised above the skin surface
  • rosacea attributes were recorded by noting diffuse redness and general erythema of the skin caused by permanently dilated capillaries or telangiectasia.
  • the test product was a white lotion with a light citrus scent. It contained 0.5% salicylic acid and 6.0% lactic acid, with a pH between 4.2 and 4.4.
  • the lotion was supplied in four 1 ounce glass bottles. For the first two weeks, test participants were instructed to apply the lotion once a day, preferably at night after cleansing the face. After two weeks, the lotion was applied in the morning and evening until symptoms were diminished.
  • Test results were collected in response to written and oral questions. Statistical analysis of the raw data was performed by a consulting statistician. Incomplete data was excluded from the analysis and conventional methods were used to verify statistical significance.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Medicinal Chemistry (AREA)
  • Birds (AREA)
  • Dermatology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Emergency Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Cosmetics (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention concerne un traitement anti-acnéique local comprenant de l'acide salicylique et de l'acide lactique et ajusté à un pH sélectionné et placé dans un excipient approprié. Les formulations décrites peuvent être utilisées par des individus atteints d'acné adulte, de couperose et ayant une peau sensible à complication acnéique.
PCT/US1996/002938 1995-03-03 1996-02-20 Composition anti-acneique douce WO1996027365A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
BR9605917A BR9605917A (pt) 1995-03-03 1996-02-20 Composição antiacne suave
JP8526992A JPH09511769A (ja) 1995-03-03 1996-02-20 刺激性のない抗アクネ組成物
AU53018/96A AU5301896A (en) 1995-03-03 1996-02-20 Gentle anti-acne composition
EP96909570A EP0756479A4 (fr) 1995-03-03 1996-02-20 Composition anti-acneique douce

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US08/397,794 US5515287A (en) 1994-03-08 1995-03-03 Navigation display apparatus for collison avoidance utilizing polygonal safety regions and predicted danger areas
US08/397,794 1995-03-03

Publications (1)

Publication Number Publication Date
WO1996027365A1 true WO1996027365A1 (fr) 1996-09-12

Family

ID=23572647

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1996/002938 WO1996027365A1 (fr) 1995-03-03 1996-02-20 Composition anti-acneique douce

Country Status (5)

Country Link
EP (1) EP0756479A4 (fr)
JP (1) JPH09511769A (fr)
AU (1) AU5301896A (fr)
CA (1) CA2187917A1 (fr)
WO (1) WO1996027365A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0721775A3 (fr) * 1994-12-13 1996-12-18 Beiersdorf Ag Combinaison d'agents actifs efficaces contre les peaux non saines, les formes légères d'acné et les bactéries grampositives
WO2002074290A3 (fr) * 2001-03-15 2004-02-19 Agis Ind 1983 Ltd Preparations dermatologiques
EP1997537A3 (fr) * 2007-05-23 2012-02-01 Coty Prestige Lancaster Group GmbH Produit cosmétique de nettoyage de la peau
GB2511350A (en) * 2013-03-01 2014-09-03 Reckitt Benckiser Brands Ltd Skincare compositions
EP1598064B2 (fr) † 2003-09-06 2015-02-25 Symrise AG Combination de alcane-diol de hydroxy-acide pour le traitement de l'acne

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004075549A (ja) * 2002-08-12 2004-03-11 Kanebo Ltd 化粧料

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4105783A (en) * 1975-07-23 1978-08-08 Yu Ruey J Therapeutic treatment of dry skin
US4608370A (en) * 1985-03-04 1986-08-26 Aronsohn Richard B Skin formulation
US5382432A (en) * 1993-11-15 1995-01-17 Elizabeth Arden Company, Division Of Conopco, Inc. Cosmetic method for treatment of skin

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
RO67357A2 (fr) * 1976-11-23 1980-01-15 Intreprinderea De Produse Cosmetice "Farmec",Ro Lotion antiacneique
CA2144509C (fr) * 1992-09-14 1999-05-18 Walter P. Smith Composition pour le conditionnement de la peau; methode de preparation et application
AU7056894A (en) * 1993-06-01 1994-12-20 Dermatology Home Products, Inc. Skin treatment method utilizing a composition and a pad
US5569651A (en) * 1995-03-03 1996-10-29 Avon Products, Inc. Gentle anti-acne composition

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4105783A (en) * 1975-07-23 1978-08-08 Yu Ruey J Therapeutic treatment of dry skin
US4608370A (en) * 1985-03-04 1986-08-26 Aronsohn Richard B Skin formulation
US5382432A (en) * 1993-11-15 1995-01-17 Elizabeth Arden Company, Division Of Conopco, Inc. Cosmetic method for treatment of skin

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP0756479A4 *

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0721775A3 (fr) * 1994-12-13 1996-12-18 Beiersdorf Ag Combinaison d'agents actifs efficaces contre les peaux non saines, les formes légères d'acné et les bactéries grampositives
WO2002074290A3 (fr) * 2001-03-15 2004-02-19 Agis Ind 1983 Ltd Preparations dermatologiques
EP1598064B2 (fr) † 2003-09-06 2015-02-25 Symrise AG Combination de alcane-diol de hydroxy-acide pour le traitement de l'acne
EP1997537A3 (fr) * 2007-05-23 2012-02-01 Coty Prestige Lancaster Group GmbH Produit cosmétique de nettoyage de la peau
GB2511350A (en) * 2013-03-01 2014-09-03 Reckitt Benckiser Brands Ltd Skincare compositions
WO2014132060A1 (fr) * 2013-03-01 2014-09-04 Reckitt Benckiser (Brands) Limited Compositions pour le soin de la peau
GB2511350B (en) * 2013-03-01 2016-11-09 Reckitt Benckiser (Brands) Ltd Skincare compositions

Also Published As

Publication number Publication date
JPH09511769A (ja) 1997-11-25
EP0756479A1 (fr) 1997-02-05
EP0756479A4 (fr) 1997-05-07
CA2187917A1 (fr) 1996-09-12
AU5301896A (en) 1996-09-23

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