WO2022172161A1 - Traitement de l'acné - Google Patents

Traitement de l'acné Download PDF

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Publication number
WO2022172161A1
WO2022172161A1 PCT/IB2022/051136 IB2022051136W WO2022172161A1 WO 2022172161 A1 WO2022172161 A1 WO 2022172161A1 IB 2022051136 W IB2022051136 W IB 2022051136W WO 2022172161 A1 WO2022172161 A1 WO 2022172161A1
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WO
WIPO (PCT)
Prior art keywords
acne
acne lesion
lesion
light
treatment
Prior art date
Application number
PCT/IB2022/051136
Other languages
English (en)
Inventor
Fernando Díez ALAEJOS
Miguel Galán Valiente
Original Assignee
Global Med Systems, S.L.
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 Global Med Systems, S.L. filed Critical Global Med Systems, S.L.
Publication of WO2022172161A1 publication Critical patent/WO2022172161A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/203Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser applying laser energy to the outside of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452Skin
    • A61B2018/00458Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452Skin
    • A61B2018/00476Hair follicles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00Radiation therapy
    • A61N5/06Radiation therapy using light
    • A61N5/0613Apparatus adapted for a specific treatment
    • A61N5/0624Apparatus adapted for a specific treatment for eliminating microbes, germs, bacteria on or in the body

Definitions

  • the present invention provides acne treatments, and more particularly light-based acne treatments.
  • Acne can be a significant health issue for adolescents and young adults, affecting up to 80% of individuals in these younger age populations. In fact, it is believed that up to 9% of the world’s population has some form of acne. In some cases, acne can lead to more serious and permanent skin lesions, like scarring. Unfortunately, acne is also associated with anxiety, a loss of self- confidence, and a risk of depression in the effected individuals. These more psychological ailments can have lasting effects on adolescents, whose population tends to be more at risk to anxiety and depression.
  • Acne generally refers to superficial lesions of the skin, often located on the face, upper chest and back. Acne is typically caused by one or more of three pathologies: excess sebum in the sebaceous gland, fat and dead cells clogged in hair follicles that trap sebum, and the presence and infection by Cutibacterium acnes bacteria on the skin. The severity of any one acne lesion is tied to the presence of one or more of these conditions.
  • the present disclosure provides for treatments of acne on animals such as mammals and including humans.
  • the acne treatments herein are light-based and include novel systems, methods and kits.
  • the present disclosure provides systems for treating a subject in need of an acne treatment
  • the system includes a light source capable of providing an appropriate light beam.
  • the light source can include a power supply, a main unit, and a handpiece.
  • the power supply, main unit and handpiece are combined in a single device, although these pieces can also be considered as separate operatively connected components.
  • the light source is capable of delivering a light beam in the blue light spectrum and typically with a wavelength of from about 420 nm to about 470 nm, and more typically from about 430 nm to about 460 nm and most typically about 445 nm to about 450 nm.
  • the light source provides a light beam of about 445 nm.
  • the light source has a pulse length of from about 50 ms to about 100 ms, and the energy can be in the range of from about 1 Watt to about 7 Watts and more typically 2 Watts to about 7 Watts.
  • the light source is a laser, and more typically, a diode laser.
  • the light source is a blue light diode laser.
  • systems can further include one or more tips for exit of the light, where the tip has a point sized at 0.1 mm to about 0.3 mm.
  • a second tip can be provided having a point that produces a 1 cm 2 area of light when the light exits, referred to herein as a sweep.
  • Some systems herein also include protective eyewear, instructions on the use and care of the light source, instructions on various treatment aspects for acne using the light source, cleaning wipes or solutions for the light source, antibiotic wipes for use on the subject before or after use of the light source for treatment of the acne, and antiseptic wipes for the same.
  • Embodiments also include methods for treating a subject in need of acne treatment.
  • the methods comprise identifying an acne lesion on the subject and administering a light beam to the acne lesion having a wavelength of from about 420 nm to about 470 nm, with a pulse length of from about 50 ms to about 100 ms and an energy of from about 1 Watt to about 7 Watts.
  • the light beam has a wavelength of about 430 nm to about 460 nm, and can be about 445 nm to about 450 nm. In one particular method, the wavelength is about 445 nm.
  • Methods can include administering a second more diffuse light beam, having an energy of from about 7 Watts to about 10 Watts, to the treated acne lesion and area surrounding the acne lesion, such that the second administration is a light sweep capable of limiting or eliminating surface bacteria on the subject’s skin.
  • aspects of the methods herein can include a light source that is a laser, and more typically a diode laser.
  • the diode laser is a blue diode laser.
  • Laser operation can include using the light source parameters herein (wavelength, pulse length and energy) and performing about 2 to 10 shots into the acne lesion. Typical shots superficially enter the subject’s skin, which in some cases can be to a depth of from about 0.7 mm to about 1 mm.
  • the methods herein utilize a light source that is capable of first evaporating a small portion of skin on the top of the acne lesion skin to open a release point in the lesion such that any infection/pus trapped in the lesion can be released, and then being capable of sweeping an area roughly centered around the lesion to act as a surface skin bactericide.
  • Kits include a light source, eyewear protection, and instructions on use.
  • Lights sources can include a power supply, a main unit for controlling the light, and a handpiece for directing the light.
  • the handpiece comes with a tip having a point of from about 0.1 mm tip to about 0.3 mm.
  • kits can also come with a tip having a point that produces a 1 cm 2 light sweep.
  • Other handpiece tips can be re-useable after sterilization or disposable. When the tips are disposable, a kit can include packages of an appropriate number of each tip, which can be, for example, 5, 10, 25, 50, 100 and the like.
  • Figure 1 shows a flow chart in accordance with method embodiments described herein.
  • Figure 2 shows a second flow chart in accordance with method embodiments described herein.
  • Figure 3 shows a third flow chart in accordance with method embodiments described herein.
  • the present invention provides systems, methods and kits for the treatment of acne. These systems, methods and kits are based on novel and surprisingly affective light-based treatments.
  • these light-based treatments utilize temporal, spatial and intensity- dependent properties of light to both maximize the treatment of acne while limiting or minimizing damage to surrounding skin.
  • the treatments are effective and timely and avoid the use of antibiotics which can lead to antibiotic resistance.
  • the articles “a” and “an” refer to one or more of the grammatical object of the article.
  • acne As used herein, “acne,” “acne lesion” or “lesion” refers to microcysts (whiteheads), blackheads, papules, pustules, nodules or other like skin ailments.
  • administering can be used interchangeably to indicate the introduction of light or a light-beam to a patient’s skin.
  • a “subject” refers to any animal that is subject to developing acne, such as humans, and may, where appropriate, be used interchangeably with the term “patient.”
  • treatment refers to any desired effect on an acne lesion, including: the destruction of the infection, evaporation of the infection, ablation of pus, reduction in size of the lesion, drainage of pus from the lesion, and including, in most instances, coagulation of the lesion after destruction, evaporation, ablation, and/or reduction in amount or drainage of pus from the lesion.
  • the invention provides systems, methods and kits for the treatment of acne, and in particular, the invention provides light-based systems, methods and kits for the treatment of targeted acne lesions.
  • the temporal, spatial and intensity-dependent properties of delivered light determines the light’s effect on an acne-lesion. These light-dependent properties have been adjusted to provide a surprisingly useful treatment for acne-lesions. These properties or parameters of light have been identified herein to both treat acne-lesions and avoid or minimize damage to surrounding tissue.
  • embodiments herein have been developed as a light therapeutic that is not, or minimally, absorbed by water (water is not heated) but is absorbed by oxyhemoglobin (allows for photocoagulation).
  • This combination of light properties allows for the photoelimination of local vascularized tissue but avoids heating of surrounding tissue.
  • the light therapy herein only has the capacity to penetrate to a superficial depth of the skin, thereby eliminating the potential of damaging tissue found below the superficial aspects of the skin.
  • light-based therapies herein also act as skin surface bactericides.
  • the systems, methods and kits utilize a light source to provide a light beam capable of treatment on a targeted acne lesion or a targeted area of skin having one or more acne lesions.
  • the light source produces a beam of light with a wavelength within the blue light spectrum.
  • the blue light has a wavelength of from about 420 nm to about 470 nm, and in more typical cases, from about 440 nm to about 460 nm, and most typically about 445 nm to about 450 nm.
  • the wavelength can be about 445 nm.
  • the light beam can be quasi-monochromatic. Light beams can have an approximate diameter of 0.1 mm to about 0.3 mm.
  • light beams in accordance with embodiments herein can have a pulse length of from about 50 ms to about 100 ms and include an energy of from about 1 Watt to about 7 Watts. In some cases, the energy is from about 2 Watts to about 7 Watts.
  • the light beam having these properties penetrates the subject’s dermis to about 0.7 mm to about 1 mm in depth.
  • an acne-lesion can be treated with from about 2 to about 10 temporally contiguous shots. Additional treatments can include a sweep of light that further treats the surface of the subject’s skin to limit or eliminate bacteria present around the previously treated acne lesion. The sweep light having an energy of from about 7 Watts to about 10 Watts.
  • Embodiments herein include systems for treating acne lesions.
  • the systems include a light source, a power supply for the light source, and safety googles for protecting both the system operator and the subject in need of acne treatment.
  • the light source can have a main unit and a handpiece for delivering a light beam.
  • the light source can be an IPL, LED or laser, and in some instances a diode laser.
  • the laser is a blue diode laser.
  • the main unit includes controls to adjust the light beam, for example the light beam wavelength, pulse length, interval between shots, and the like.
  • the main unit can include a monitoring screen for easy interface with a user.
  • the main unit can also include a power button for turning on and off the unit.
  • the handpiece herein can be maneuverable such that a user can easily manipulate the handpiece over various aspects of a subject’s face, upper back, chest, and the like.
  • the handpiece has a tip for directing a light beam at an acne lesion and can include a distance gauge for accurately positioning the handpiece tip over an acne lesion.
  • Distance gauges can be of different lengths and are typically between 3 cm and 6 cm. Distance gauges allow the user to maintain the same distance from the skin and maintain the same light beam size on the skin.
  • the handpiece can include removable tips for focus of the light beam, a tip can have a point where the light beam exits, the point being from 0.1 mm to 0.3 mm in diameter.
  • a sweeping tip for a 1 cm 2 light administration area is also provided. These tips can be disposable.
  • a protective window can be included on the handpiece to protect the diode, which is located in a cavity, from collecting dust or other materials.
  • the power source is such as is appropriate for the light source and is capable of delivering a voltage and current to supply the light source to produce the light beam as is known in the art.
  • a foot pedal or other like device can be placed between the power source and main unit to control firing of the light source, for example. Other like devices can be used in place of the foot pedal so as to limit inadvertent emissions of the light source. In typical cases, the foot pedal is pneumatic or air actuated.
  • protective eyewear is also provided.
  • a pair of protective eyewear googles (one for user and one for subject) are included such that the googles are protective of light beams in the blue light spectrum.
  • systems herein can also include a magnifying google. Magnifying googles can be used by the light source operator to allow for an enhanced view of the subject’s skin.
  • Systems herein may also include instructions for use of the power source, light source, handpiece and other aspects of the embodiments herein. Instructions may include risk evaluation for use of the light source on subjects having scarring or skin keloids and advice for whether the subject’s acne may be better treated using a conventional antibiotic or other treatment. Instructions may also include troubleshooting and maintenance materials for the power source, light source and handpiece.
  • systems may include cleaning and sterilization fluids or wipes for cleaning the light source and handpiece, antiseptic wipes or ointments for treatment of the subject’s skin pre- or post-treatment, antibiotics (topical or oral), replacement tips for the handpiece, and the like.
  • methods are provided for the treatment of acne-lesions on subjects in need thereof.
  • Methods include the use of light to penetrate a subject’s dermis at the site of an acne lesion to accomplish photothermolysis of the lesion.
  • Embodiments herein include the use of light or light beams having appropriate power, wavelength, light pulse length and number of pulses or shots per treatment session useful in the treatment of acne. The light is only capable of superficial penetration into the subject’s dermis and has little or no heating or damage beyond the target lesion.
  • identification of a region of skin on a subject having one or more acne- lesions or one or more targeted acne-lesions is performed by a health care professional.
  • the term “acne-lesion” will refer to either circumstance, a region of skin having acne-lesions or a targeted acne-lesion in and of itself.
  • a light-source in accordance with embodiments herein is obtained.
  • the parameters of the light-source are manipulated to provide a light-beam capable of treating the acne-lesion as further described herein.
  • Operation of the light source is performed to apply a light-beam on the acne-lesion such that the light-beam has a wavelength in the blue-light spectrum.
  • the light-beam as described is applied for an appropriate time and under appropriate conditions and the acne-lesion treated.
  • a further area of skin associated with the acne-lesion is further swept with a more diffuse light to act as a surface treatment to limit or further eliminate bacteria from the subject’s skin.
  • an anti -bacterial wipe can be applied to the treated acne lesion and to an area of skin around the treated acne-lesion.
  • the subject and light source user obtain protective eyewear to protect their eyes from the light beam produced by the light source.
  • methods include identification of a region of skin on a subject having an acne- lesion. Such identification can be by a health care professional accustomed to treating skin ailments and acne in particular, such as a health technician, nurse, physician assistant, doctor, and the like, or other trained professionals having the requisite knowledge and skill to operate the light source herein.
  • Light sources in accordance with embodiments herein include IPLs, LEDs, lasers, and in particular, diode lasers and blue diode lasers.
  • Light sources are provide a light beam found in the blue light spectrum, and more typically, from about 420 nm to about 470 nm, and most typically from 430 nm to about 460 nm, and in some aspects about 445 nm to about 450 nm.
  • the light beam has a wavelength of 445 nm.
  • the light source also provides a pulse length of from about 50 ms to about 100 ms with an energy of from about 1 Watt to 7 Watts, and more particularly from about 2 Watts to about 7 Watts.
  • An operator of the light source can modify any one of the above parameters based on the operator’s requirements for treating a particular subject.
  • Light sources can include a tip having an exit point or point for the light beam such that the point has a diameter of from about 0.1 mm to about 0.3 mm. The light beam exits through the point and into the acne lesion.
  • the light source also includes a tip having a 1 cm 2 spot diameter for sweeping of skin after an acne-lesion treatment.
  • a distance gauge can also be included on the light source tip, such that the user can identify and position the light source tip above an acne lesion to be treated. In some cases, the distance gauge can be between 3 and 6 cm.
  • the light source is equipped with replaceable tips, one tip for the 0.1 mm to 0.3 mm point and one tip for the sweep.
  • a light source have multiple replaceable tips for use by the operator where the operator can mix and match the tip for the subject’s particular acne. So for example, a light source could come with replaceable tips having a tip with a 0.1 mm point, a tip with a 0.15 mm point, a tip with a 0.2 mm point, a tip with a 0.3 mm point and a tip used for a sweep.
  • the user applies a first tip to the light source having an exit point of about 0.1 mm to about 0.3 mm for focusing a light beam onto a target acne-lesion.
  • the focused light beam evaporates a small portion of skin on the acne lesion so as to open a way for pus/infection release.
  • the light beam can be pulsed from 1 to 15 times, and more typically 2 to 10 times, in a single treatment.
  • the user then replaces the tip having a point of from about 0.1mm to 0.3 mm with a tip having a sweep point that allows for a 1 cm 2 area to sweep the new area of skin with the light beam such that the sweep performs a bactericide on any skin surface bacteria.
  • the sweep is performed with a light having from about 7 to about 10 Watts.
  • the user does a pre-examination of the subject prior to administration of the light beam to determine if the subject has pre-existing scarring or skin keloids.
  • the user provides an alternative treatment for acne, for example, antibiotic containing skin ointments.
  • a flow chart shows a method in accordance with embodiments herein 100.
  • a light source having the appropriate temporal, spatial and intensity light parameters is obtained.
  • a light beam is emitted from the light source at a acne lesion so as to treat the acne lesion.
  • a light sweep is applied to an area of the skin that includes the treated acne lesion, and is typically, centered on the treated acne lesion.
  • a flow chart shows an alternative method in accordance with embodiments herein 200.
  • a subject is identified in need of acne treatment.
  • the target acne lesions are identified on the subject for treatment using embodiments herein.
  • a light source having a monochromatic blue light beam is obtained.
  • the light source is used to treat the acne lesion such that the light bean is focused on the lesion thereby opening and releasing the infection trapped and then causing ablation of pus, reduction in size of the lesion, drainage of pus from the lesion, and including, in most instances, coagulation of the lesion after destruction, evaporation, ablation, and/or reduction in amount or drainage of pus from the lesion.
  • a further blue light sweep is applied to the acne lesion and skin surrounding the lesion to act as a bactericide on surface bacteria on the subject’s skin.
  • a flow chart shows another alternative method in accordance with embodiments herein 300.
  • a subject in need of acne treatment is identified.
  • the subject is also examined for skin conditions that may indicate a need to use a different acne treatment outside the embodiments as described herein. Several of these conditions include skin scarring and/or skin keloids. If the subject has such a skin condition, the subject is provided with an alternative, conventional treatment, like antibiotics 308. If the subject does not have a skin condition that prohibits the use of light therapies, operation 310 has the light source user or health care professional identify target acne lesions for treatment. In operation 312, the identified target lesions are cleaned by the light source operator, or other health care professional, with an anti-septic cleaning solution or wipe.
  • a blue light diode laser having a light beam of about 420 nm to about 470 nm, a pulse length of about 50 to 100 ms and an energy of about 1 Watt to about 7 Watts is obtained.
  • a tip having an exit point of from about 0.1 mm to about 0.3 mm for the light is positioned over the target acne lesion and the light beam applied.
  • the light beam is directed through a tip having a point to sweep the subject’s skin with an energy of 7 Watts to 10 Watts.
  • the light sweep is meant to remove surface skin bacteria at and around the target acne lesion. In some aspects, the sweep is of a 1 cm 2 area.
  • kits for use in the treatment of acne in a subject in need thereof can include a light source with appropriate tips, protective eyewear, and instructions.
  • Lights sources in accordance with kit embodiments can include a power supply, a main unit for controlling the light, and a handpiece for directing the light.
  • the handpiece comes with a tip having a point of from about 0.1 mm to about 0.3 mm.
  • kits can also come with a tip having a point that produces a 1 cm 2 light sweep.
  • Other handpiece tips can be re- useable after sterilization or can be disposable. When the tips are disposable, a kit can include packages of an appropriate number of each tip.
  • the kit would include a tip having a 0.1 mm point, a tip having a 0.2 mm point, a tip having a 0.3 mm point and a tip for use of a sweep. Kits may also include a disposable distance gauge for extension off any one tip to ensure proper positioning of the handpiece for use in treating acne.
  • kits can also include antibiotics, either topical or systemic, for use after application of the light beams herein.
  • Cleaning supplies or wipes can also be included in kits for use in cleaning the light source, including the handpiece tips.
  • the kit embodiments can include instructions on the use of the light source, on the maintenance of the light source and/or the use of the light source in the treatment of acne.
  • kits can be sold that only include disposable handpiece tips, cleaning wipes and instructions, for example, replacement kits sold by a manufacturer where the purchaser has already purchased the light source. In these kits, the user may wish to purchase additional disposable tips or cleaning supplies for the light source.

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  • Physics & Mathematics (AREA)
  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Optics & Photonics (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

L'invention concerne des systèmes, des méthodes et des kits destinés au traitement de l'acné. L'invention concerne des sources de lumière ciblées ayant des propriétés temporelles, spatiales et dépendantes de l'intensité pour traiter l'acné tout en réduisant au maximum les dommages aux tissus environnants.
PCT/IB2022/051136 2021-02-09 2022-02-09 Traitement de l'acné WO2022172161A1 (fr)

Applications Claiming Priority (2)

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US202163147443P 2021-02-09 2021-02-09
US63/147,443 2021-02-09

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WO2022172161A1 true WO2022172161A1 (fr) 2022-08-18

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050177140A1 (en) * 2004-02-06 2005-08-11 Harvey Jay Pulsed light treatment apparatus and associated method with preliminary light pulse generation
US20060167531A1 (en) * 2005-01-25 2006-07-27 Michael Gertner Optical therapies and devices
US20070083190A1 (en) * 2005-10-11 2007-04-12 Yacov Domankevitz Compression device for a laser handpiece
US20100262065A1 (en) * 2009-04-09 2010-10-14 Shane James Lynch Liquid submersed light emitting fiber optic handle apparatus system
US20180071024A1 (en) * 2015-03-20 2018-03-15 Sienna Biopharmaceuticals, Inc. Enhanced efficacy and targeted topical delivery of drugs to skin with nanoparticles

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050177140A1 (en) * 2004-02-06 2005-08-11 Harvey Jay Pulsed light treatment apparatus and associated method with preliminary light pulse generation
US20060167531A1 (en) * 2005-01-25 2006-07-27 Michael Gertner Optical therapies and devices
US20070083190A1 (en) * 2005-10-11 2007-04-12 Yacov Domankevitz Compression device for a laser handpiece
US20100262065A1 (en) * 2009-04-09 2010-10-14 Shane James Lynch Liquid submersed light emitting fiber optic handle apparatus system
US20180071024A1 (en) * 2015-03-20 2018-03-15 Sienna Biopharmaceuticals, Inc. Enhanced efficacy and targeted topical delivery of drugs to skin with nanoparticles

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