WO2019175902A1 - Préparation topique pour diverses affections cutanées - Google Patents

Préparation topique pour diverses affections cutanées Download PDF

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Publication number
WO2019175902A1
WO2019175902A1 PCT/IN2019/050216 IN2019050216W WO2019175902A1 WO 2019175902 A1 WO2019175902 A1 WO 2019175902A1 IN 2019050216 W IN2019050216 W IN 2019050216W WO 2019175902 A1 WO2019175902 A1 WO 2019175902A1
Authority
WO
WIPO (PCT)
Prior art keywords
skin
topical preparation
tretinoin
formulation
azelaic acid
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.)
Ceased
Application number
PCT/IN2019/050216
Other languages
English (en)
Inventor
Vikram AIMA
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.)
La Pristine Bioceuticals Pvt Ltd
Original Assignee
La Pristine Bioceuticals Pvt Ltd
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
Application filed by La Pristine Bioceuticals Pvt Ltd filed Critical La Pristine Bioceuticals Pvt Ltd
Publication of WO2019175902A1 publication Critical patent/WO2019175902A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
    • 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
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • 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
    • A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/203—Retinoic acids ; Salts thereof
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • 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)
    • A61K36/886—Aloeaceae (Aloe family), e.g. aloe vera
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; 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
    • A61K8/361—Carboxylic acids having more than seven carbon atoms in an unbroken chain; Salts or anhydrides 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
    • A61K8/362—Polycarboxylic 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
    • A61K8/67—Vitamins
    • A61K8/676—Ascorbic acid, i.e. vitamin C
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • 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
    • A61Q19/02—Preparations for care of the skin for chemically bleaching or whitening the skin

Definitions

  • the invention is in the field of topical preparations for skin.
  • the invention specifically provides for topical preparations for skin treatment comprising of main ingredients as Azelaic acid and Tretinoin along with additional ingredients.
  • Topical preparations are used for various skin treatment such as repairing, improving, partially or fully healing, or otherwise treating a wide variety of different skin disorders, diseases, conditions, maladies, dryness and/or the like, of the skin of mammals, such as inflammation, redness, hyperpigmentation, itching, bumps, blisters, cuts, punctures, other wounds, cracking, severe dryness, allergic reactions, insect bites, trauma, irritant dermatitis, contact dermatitis, seborrheic dermatitis, stasis dermatitis, perleche, psoriasis, eczema, eczema craquele, acne, allergies, other skin irritations, xerosis, disease related skin conditions and dryness from medications, or causing the skin to feel less painful, less irritated, less itchy, softened, soothed and/or conditioned.
  • skin disorders such as inflammation, redness, hyperpigmentation, itching, bumps, blisters, cuts, punctures, other wounds, crack
  • Azelaic acid is a dicarboxylic acids medication for skin used to treat rosacea, melasma, post inflammatory hyperpigmentation, inflammatory papule and pustules, flushing and pimples on the face.
  • Azelaic acid topical preparation is used to treat the pimples and swelling caused by acne. It treats rosacea by decreasing the swelling and redness of the skin. It may be working by killing the bacteria that infect pores and decreasing production of keratin, a natural substance that can lead to the development of acne.
  • the common side effects of Azelaic acid application is sensation of burning, stinging and tingling besides itching, dry skin, irritation and erythema. There are also other less common side effects associated with
  • Azelaic acid application including contact dermatitis, edema, acne, facial burning, iridocyclitis after accidental exposure to the eyes, worsening of asthma/dyspnea/wheezing and serious allergic reactions.
  • Tretinoin is another medication used for skin treatment. It is a retinoid medication used to treat acne, photo-aged skin and post inflammatory hyperpigmentation. It is used to decrease the number and severity of acne pimples and promote quick healing of pimples that do develop and it works by affecting the growth of skin cells. Following the Application of tretinoin to the skin leads to mild stinging or a sensation of warmth usually leads to local inflammation. The common side effects of tretinoin are dryness, scaling, itching, and redness.
  • the invention provides for a topical preparation for various skin ailments of formulation comprising Azelaic Acid and Tretinoin preferably with Vitamin C.
  • the preferred concentration of said ingredients are 5% to 25% Azelaic Acid and 0.01% to 0.1%
  • the formulation may further comprise of Aloe vera, preferably as Aloe vera gel in concentration of 0.5 to 2.5% of the total formulation.
  • the most preferred formulation comprises of:
  • the preparation of present invention can be used for treatment of multiple skin ailments.
  • the two medications Azelaic Acid (of different therapeutic strengths) and Tretinoin (different therapeutic strengths) are available commercially as solo therapies for common skin ailments/indications or in combination with other ingredients but not together.
  • the invention discloses skin formulations comprising both the medications together (in combination) for synergistic approach towards treating skin disorders minimal skin irritation, photosensitivity or other side effects.
  • the specific formulations including a unique combination of ingredients, and weight percent thereof, have surprisingly and unexpectedly been determined via experimentation and testing to function extremely well together, providing topical skin compositions that are extremely efficacious.
  • Vitamin C is a potent antioxidant that can be used topically to treat skin ailments specifically to prevent changes associated with photoageing and for the treatment of hyperpigmentation, tissue inflammation. It may also be used for promotion of tissue healing
  • the unstable nature of Vitamin C and being difficult to deliver into the dermis in the optimum dosage have been a hindrance in the delivery of Vitamin C into the dermis.
  • the invention discloses formulations comprising Azelaic Acid and Tretinoin along with Vitamin C to not only achieve the additional benefit of imparting the antioxidant benefits but also additionally providing mode of delivery of Vitamin C to the skin.
  • the combined formulation comprising the three ingredients wherein Azelaic Acid and Tretinoin are causing the respective effects on the skin with new cells being formed also allow for the Vitamin C to be delivered to the dei is appropriately.
  • the preferred formulation of the invention uses stabilized derivatives of Vitamin C as base for further improved efficacy.
  • Stable ascorbic acid derivatives such as 3- Glyceryl Ascorbate are preferred.
  • Stable derivatives such as Amitose 3GA produced by binding vitamin C (ascorbic acid) to glycerin has skin-moisturizing effect as well as inhibitory effect on melanin production. It enhances collagen production, and exerts an intracellular antioxidant effect. Therefore there is added advantage of Stabilized Vitamin C derivative as a skin antioxidant.
  • Vitamin C form in the formulation provides further advantages for the skin such as photoprotection, anti-aging effect, moisturizing and skin conditioning effect, greater stability (enhanced shelf-life) and skin whitening to name a few.
  • excipients/ additives/ preservatives/inactives can also be used in the formulation of the invention including Cetyl Alcohol, Glyceryl Monostearate, Stearic Acid, Isopropyl Myristate, Gelot-64, Triethanolamine, PEG-4000, Phenoxyethanol, Allention, Glycerin, Menthol, Sepiclam, Fragrance Neo, Carbomer -980 and purified water
  • Another embodiment of the invention is the use of Aloe vera as base of the formulation.
  • Aloe vera has known usage in treatment of skin ailments besides other benefits and was used as an adjunct in some of the combination formulations prepared in accordance with the invention.
  • the topical preparations of the invention include 5% to 25% Azelaic Acid concenteration and 0.01% to 0.1% Tretinoin besides other ingredients.
  • the topical preparations of the invention are preferably comprising stabilized Vitamin C and 10% Azelaic Acid strength along with 0.05% Tretinoin.
  • the topical preparations of the invention preferably also include Aloe vera.
  • inactives used including solvents, thickening agents
  • the inventions tested 50 formulation (actives + other ingredients) on human volunteers and after the trial, the volunteers reported marked reduction in skin irritation.
  • the formulation of the invention ensures reduced skin irritation and wide scope of treating multiple indications.
  • a preferred embodiment of the invention is a formulation comprising Azelaic Acid 10% and Tretinoin 0.05% with Aloe Vera and 3- Glyceryl Ascorbate (in base).
  • the invention therefore provides for a topical preparation for various skin ailments of formulation comprising Azelaic Acid and Tretinoin preferably with Vitamin C.
  • the preferred concentration of said ingredients are 5% to 25% Azelaic Acid and 0.01% to 0.1 %
  • the formulation may further comprise of Aloe vera, preferably as Aloe vera gel in concentration of 0.5 to 2.5% of the total formulation.
  • the most preferred formulation comprises of:
  • the invention further encompasses methods for producing the above formulations, and methods of skin treatment for multiple ailments by topically administering or otherwise applying effective amounts of the composition thereof.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Birds (AREA)
  • Dermatology (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Inorganic Chemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Emergency Medicine (AREA)
  • Biotechnology (AREA)
  • Botany (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Medical Informatics (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Cosmetics (AREA)

Abstract

L'invention concerne une préparation topique pour diverses affections cutanées dont la formulation comprend de l'acide azélaïque et de la trétinoïne de préférence avec de la vitamine C. La concentration préférée desdits ingrédients est de 5 % à 25 % d'acide azélaïque et de 0,01 % à 0,1 % de trétinoïne avec 1 % à 5 % de vitamine C sous forme stabilisée. La formulation peut en outre comprendre de l'Aloe vera, de préférence sous la forme d'un gel d'Aloe vera en concentration de 0,5 à 2,5 % de la formulation totale.
PCT/IN2019/050216 2018-03-16 2019-03-18 Préparation topique pour diverses affections cutanées Ceased WO2019175902A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN201811009793 2018-03-16
IN201811009793 2018-03-16

Publications (1)

Publication Number Publication Date
WO2019175902A1 true WO2019175902A1 (fr) 2019-09-19

Family

ID=67906476

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IN2019/050216 Ceased WO2019175902A1 (fr) 2018-03-16 2019-03-18 Préparation topique pour diverses affections cutanées

Country Status (1)

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WO (1) WO2019175902A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4045030A4 (fr) * 2019-10-16 2024-03-13 Curology, Inc. Compositions et méthodes de traitement de l'acné et du photovieillissement

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120315235A1 (en) * 2011-06-08 2012-12-13 Scott Alan Weisenfluh Emu oil in combination with other active ingredients for treating skin imperfections
US8568749B2 (en) * 2009-04-02 2013-10-29 Sesvalia Usa, Llc Systems and methods for skin rejuvenation
WO2014188276A2 (fr) * 2013-04-22 2014-11-27 Neocutis Sa Compositions d'antioxydants et procédés d'utilisation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8568749B2 (en) * 2009-04-02 2013-10-29 Sesvalia Usa, Llc Systems and methods for skin rejuvenation
US20120315235A1 (en) * 2011-06-08 2012-12-13 Scott Alan Weisenfluh Emu oil in combination with other active ingredients for treating skin imperfections
WO2014188276A2 (fr) * 2013-04-22 2014-11-27 Neocutis Sa Compositions d'antioxydants et procédés d'utilisation

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
DEL ROSSO: "CUTIS; cutaneous medicine for the practitioner", JQ1, vol. 77(2 Suppl), no. 22, 4 March 2006 (2006-03-04) *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4045030A4 (fr) * 2019-10-16 2024-03-13 Curology, Inc. Compositions et méthodes de traitement de l'acné et du photovieillissement

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