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WO2006119972A1 - Methodes de traitement de la peau au moyen d'un rayonnement pulse intense a fluidite elevee - Google Patents

Methodes de traitement de la peau au moyen d'un rayonnement pulse intense a fluidite elevee Download PDF

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Publication number
WO2006119972A1
WO2006119972A1 PCT/EP2006/004340 EP2006004340W WO2006119972A1 WO 2006119972 A1 WO2006119972 A1 WO 2006119972A1 EP 2006004340 W EP2006004340 W EP 2006004340W WO 2006119972 A1 WO2006119972 A1 WO 2006119972A1
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tgf
fluency
pulsed light
intense pulsed
skin
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PCT/EP2006/004340
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English (en)
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Careen A. Schroeter
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Schroeter Careen A
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Publication of WO2006119972A1 publication Critical patent/WO2006119972A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical 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
    • A61B18/203—Surgical 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452—Skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B2018/1807—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using light other than laser radiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/06—Radiation therapy using light
    • A61N5/0613—Apparatus adapted for a specific treatment
    • A61N5/0616—Skin treatment other than tanning

Definitions

  • TGF- ⁇ Transforming growth factor-beta
  • TGF- ⁇ acts via autocrine and paracrine mechanisms to regulate the interactions between cells and between cells and matrix in wound healing, involving inflammation, re- epithelialization, angiogenesis, and the production of extracellular matrix (Roberts and Sporn (1996) The Molecular and Cellular Biology of Wound Repair. Clark RAF eds . pp 275-308 Plenum Press, New York; O'Kane and Ferguson (1997) Int. J. Biochem. Cell Biol. 29:63-78).
  • TGF- ⁇ stimulates the synthesis of multiple extracellular matrix components, including collagens, fibronectin, vitronectin, tenascin, and proteoglycans (Pearson, et al .
  • TGF- ⁇ may act as a feedback for extracellular matrix formation.
  • TGF- ⁇ is also involved in scar formation as neutralization of TGF- ⁇ l and TGF- ⁇ 2 in adult wounds reduces scarring in rat dermal wounds (Shah, et al . (1994) J. Cell Sci. 107:1137-57).
  • exogenous addition of TGF- ⁇ 3 to dermal rat wounds results in reduced scar formation (Shah, et al. (1995) J " . Cell Sci.
  • TGF- ⁇ isoforms of TGF- ⁇ can have opposite effects in wound repair although the mechanisms behind these differences are still under investigation (Cowin, et al. (2001) Bur. J. Dermatol. 11:424-31). TGF- ⁇ is also found to be involved in ' lymphopoiesis and is required for the development of plasma cells secreting all secondary isotypes (Lebman and Edmiston (1999) Microbes Infect. 1:1297-304).
  • TGF- ⁇ plays important roles in the induction of catagen phase of the human hair cycle (Tsuji, et al . (2003) J “ . Investig. Dermatol. Symp. Proc. 8:65-8; Soma, et al . (2002) J “ . Invest. Dermatol. 118: 993-7).
  • An isoform of TGF- ⁇ acts as an inducer of hair follicle morphogenesis and is both required and sufficient to promote this process (Foitzik, et al . (1999) Dev. Biol. 2122:278-89).
  • extracellular matrix composed largely of different collagens, proteoglycans, and glycoproteins.
  • This extracellular matrix is a substrate for tissue morphogenesis, which lends support and flexibility to mature tissues and acts as an epigenetic informational unit in the sense that it transduces and integrates intracellular signals via distinct cell surface receptors. Consequently, extracellular matrix-receptor interactions have a profound influence on major cellular programs including growth, differentiation, migration, and survival.
  • TN tenascin
  • TN-C tenascin family of glycoproteins
  • TN-R tenascin receptor
  • TN-W tenascin-Y
  • tenascin and transforming growth factors have been analyzed in the diagnosis and prognosis of various diseases and pathological conditions including breast cancer, wherein it has been demonstrated that tenascin limits tumor spread (Kaya, et al . (2002) Eur. J. Gynaecol. Oncol. 23:261-3). Immunohistochemical detection of molecules involved in inflammatory reaction can be useful for the diagnosis of vitality in skin wounds.
  • TGF- ⁇ The role of TGF- ⁇ in the pathogenesis of liver diseases and its possible use as an indicator of disease progression has been suggested (Flisiak, et al. (2000) Wiad. Lek. 53:530-7).
  • TGF- ⁇ TGF- ⁇
  • radiation therapy Barcellos-Hoff (1993) Cancer Res. 53:3880-6
  • TGF- ⁇ has been shown to be rapidly activated after exposure of mice to 60 Co- ⁇ radiation, which also generates reactive oxygen species.
  • Light therapy is an emerging field, wherein light emitting diodes and other emitters of electromagnetic radiation are used to treat various medical conditions such as acne, hair growth stimulation, hair growth inhibition, scar reduction and removal, wrinkle reduction, etc.
  • U.S. Patent Application Serial No. 10/119,772 describes the manipulation of collagen, fibroblast, and fibroblast-derived cell levels in mammalian tissue using a plurality of pulses from at least one source of narrowband, multichromatic electromagnetic radiation (e.g., from a light emitting diode, a laser, a fluorescent light source, an organic light emitting diode, a light emitting polymer, a xenon arc lamp, a metal halide lamp, a filamentous light source, an intense pulsed light source, a sulfur lamp, and combinations thereof) having a dominant emissive wavelength of from about 300 nm to about 1600 run, and wherein said pulses have a duration of from about 0.1 femtoseconds to about 100 seconds, the interpulse delay between said
  • Light therapy has also been used employed in the treatment of skin diseases such as psoriasis.
  • psoralen administered orally or topically before ultraviolet-A exposure, selectively induces T-lymphocytes to undergo apoptosis (Coven, et al . (1999) Photodermatol . Photoimmunol. Photomed. 15:22-7); however, this treatment also suppresses DNA-synthesis by cross-linking DNA-strands and conjugating proteins thereby causing cell cycle arrest.
  • UVB Ultraviolet-B light
  • Another treatment using UV-light is the 308-nm Excimer laser, wherein psoriasis lesions are irradiated with UVB laser light (Gerber, et al . (2003) Br. J. Dermatol. 149:1250-8; Trehan and Taylor (2002) J. Am. Acad. Dermatol. 47:701-8; Feldman, et al . (2002) J. Am. Acad. Dermatol. 46:900-6; Asawanonda, et al . (2000) Arch. Dermatol. 136:619-24).
  • the present invention relates to a method for increasing expression of TGF- ⁇ by exposing tissue to a high-fluency, intense pulsed light source.
  • the present invention also relates to a method for modulating an immune response and a method for treating a disease or condition of the skin by exposing skin to a high-fluency, intense pulsed light source.
  • Figure 1 illustrates the relative expression of tenascin and TGF- ⁇ in the follicular bulb (Figure IA) , germinative epidermis (Figure IB) and in plasma cells (Figure 1C) up to approximately 4 months after treatment with an intense pulsed light source.
  • a high-fluency, intense pulsed light source can induce the expression of TGF- ⁇ in skin cells, resulting in the release of extracellular matrix proteins such as tenascin, and an increase in the concentration of fibroblasts and plasma cells.
  • the high-fluency, intense pulsed light source methodology disclosed herein produces an artificial wound which stimulates the immune system and extracellular matrix formation
  • the present invention relates to the use of a high-fluency intense pulsed light source for dermatologic treatment and plastic surgery treatment.
  • Such dermatologic treatment includes, e.g., accelerating wound and burn healing and the treatment of skin diseases such as psoriasis and eczema.
  • pigs were treated with 40 flashes (6.5-21 ms) of light having a wavelength ranging from 565 to 695 run and a fluency of 35-60 J/cm 2 . With higher fluency, erythema was observed. Using a wavelength of 640 nm, pulse time between 4.2 to 4.8 milliseconds (ms) and energy of 35 J/cm 2 , negligible erythema was observed. While no blisters were identified, hair on the pigs was burnt and transient depigmentation was observed, but disappeared after some time.
  • Biopsy samples taken from the irradiated pigs were stained for the presence of TGF- ⁇ l and tenascin.
  • TGF- ⁇ l and tenascin were stained for the presence of TGF- ⁇ l and tenascin.
  • the appearance of TGF- ⁇ l in the basal epidermal layer and the follicular bulb was detected. Fibroblasts and plasma cells were also strongly positive.
  • the outermost epidermis, endothelial vessels, follicular bulb, fibroblasts and plasma cells were intensely stained (Figure 1).
  • TGF- ⁇ l immunoreactivity decreased after 2 weeks, reaching a level similar to that found on the first day of treatment. After one month, the expression of TGF- ⁇ reached a peak value and then began to slowly fall in the second and third month. Subsequently, TGF- ⁇ l levels began to increase and on day 120 elevated levels were observed.
  • the present invention is a method for increasing TGF- ⁇ levels, in particular TGF- ⁇ l, in a tissue (e.g., human or mammalian skin) using an effective amount of high-fluency, intense pulsed light.
  • An effective amount of said light is an amount which elevates or increases the absolute or relative amounts of TGF- ⁇ in the tissue being treated by 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90% or 100% compared to the surrounding tissue or a similar tissue which has not been treated with the high-fluency, intense pulsed light source (e.g., the same tissue before treatment) .
  • TGF- ⁇ levels can be monitored in accordance with the immunohistochemical methods disclosed herein or with more quantitative methods such as ELISA, western blot analysis, northern blot analysis or RT-PCR.
  • fluency is defined as the power level of the radiation reaching target tissue.
  • a high- fluency radiation source produces about 3 to 90 joule per square centimeter (J/cm 2 ) of tissue.
  • high-fluency of about 10 to 50 J/cm 2 is employed.
  • high-fluency of about 35 J/cm 2 is employed.
  • any device that emits intense pulsed light in a bandwidth of ⁇ about 100 nanometers around a dominant wavelength can be can be used in accordance with the methods disclosed herein.
  • any intense pulsed light source capable of exposing the target tissue with from about 3 to 90 J/cm 2 of energy in the desired wavelength will be able to effect an increase in TGF- ⁇ .
  • the tissue penetration depth for intact skin may be different than the tissue penetration depth for ulcerated or burned skin and may also be different for skin that has been abraded or enzymatically peeled or that has had at least a portion of the stratum corneum removed.
  • the wavelength used for any particular application can vary.
  • light having a dominant wavelength emission in the range of about 500 nm may be more suitable for epidermal layers of skin as such a short wavelength has limited depth of penetration, whereas light having a wavelength of about 600 nm to about 660 nm can more easily penetrate to a greater depth, if treatment of the lower dermal layers or even deeper is desired.
  • the selection of the dominant wavelength of the radiation emitter is also dependent on the depth of treatment desired. Suitable wavelengths for inducing TGF- ⁇ are in the range of 590 to 690 nm.
  • Exposure time is another aspect of intense pulsed light which can vary with the desired effect and the target cell, tissue or organ.
  • pulse lengths can vary from less than one picosecond to several seconds with interpulse intervals of a few picoseconds to a few hundred milliseconds.
  • the pulse length is in the range of 0.1 to 500 milliseconds and the interpulse interval in the range of 20 to 60 milliseconds.
  • pulse durations of from about 4.2 to 4.8 milliseconds with an interpulse interval of about 20 milliseconds are particularly suitable.
  • the number of pulses (also referred to as repetitions or flashes) per treatment can also be varied. For example, large numbers of pulses may be less effective at inducing TGF- ⁇ than a smaller numbers of pulses.
  • a treatment regime can include between 10 and 100 pulses. In particular embodiments, the number of pulses per treatment is in the range of 40. Further, a treatment can be repeated multiple times over a given period of time (e.g., weeks or months) to achieve the desired result.
  • light penetration into the target tissue can be optimized by varying the treatment head of the intense pulsed light source.
  • a large spot size diminishes the scattering of the light beam.
  • Treatment head size can vary from 8-10 mm x 20-45 mm.
  • a particularly suitable treatment head is in the range of 8 mm x 34-35 mm.
  • a high-fluency, intense pulsed light source used in accordance with the instant methods has an emissive wavelength of from about 435 run to about 1900 nm, wherein the pulses have a duration of from about 2 ms to about 30 ms, and the energy fluence received by the tissue is about 3 to 90 joule per square centimeter.
  • Suitable flashlamp systems which can be used for carrying out the methods disclosed herein include, but are not limited to, the IPLTM Quantum, VASCULIGHTTM, and LUMENIS ONETM, PHOTODERMTM and EPILIGHTTM systems as well as those disclosed in GB 2,293,648; EP 0 565 331; U.S. Patent No. 5,405,368; and WO 91/15264.
  • the VASCULIGHTTM ESC Medical Systems Ltd. , Yokneam, Israel
  • IPLTM Quantum ESC Sharplan, Yokneam, Israel
  • these flashlamps use noncoherent light of a broad-band spectrum in the range of 435-1900 nm.
  • cut-off filters e.g., 515, 550, 570, 590, 615, 645, 695, and 795 nm
  • the pulse duration ranges between 2-5 ms (VASCULIGHTTM) and 6-26 ms
  • VASCULIGHTTM and 5-45 J/cm 2 (IPLTM Quantum) can be achieved.
  • Other suitable intense pulsed light sources or flashlamps which can be used in accordance with the parameters disclosed herein are well-known to those of skill in the art.
  • a water-containing gel or solution is used between the skin and the intense pulsed light source probe during treatment to facilitate optical coupling of the light and facilitate heat transfer from the epidermis to the gel.
  • Inflammation is the normal acute reaction of the tissues after any wound or injury. Macrophages and neutrophils enter the wounded area and start to clean up foreign material, bacteria and dead cells (Clark, et al.
  • TGF- ⁇ l and matrix metalloproteinase levels in the medium of cultured cells have been found to be significantly elevated after near-infrared irradiation and repeated exposure has been associated with a significant acceleration in the rate of wound closure (Danno, et al. (2001) Photodermatol . Photoimmunol . Photomed. 17:261-5). Studies in humans have shown that exposure to short-wave ultraviolet light significantly decreases the time to healing of superficial pressure ulcers (Wills, et al .
  • granulation tissue intensely stains with anti-tenascin serum and decreases as granulation tissue is replaced with reconstructed dermal tissue at 7-14 days (Betz, et al. (1993) Int. J. Legal Med. 105:325-8). Further, tenascin appears first in the wound area pericellularIy around fibroblastic cells approximately 2 days after wounding and after 5 days or more, intensive reactivity for tenascin is observed in the lesional area (dermal-epidermal junction, wound edge, areas of bleeding) and decreases to undetectable levels in the scar tissue (-1.5 months; Betz, et al. (1993) supra) .
  • the present invention embraces the use of a high fluency intense pulsed light source to modulate (e.g., increase or decrease) an immune response and to treat diseases or conditions of the skin.
  • a high fluency intense pulsed light source to modulate (e.g., increase or decrease) an immune response and to treat diseases or conditions of the skin.
  • the skin of a subject in need of such immunomodulation or treatment of a disease or condition is exposed to an effective amount of high- fluency, intense pulsed light.
  • An effective amount of said light is an amount which causes an increase in TGF- ⁇ (e.g., as discussed supra), or in the context of clinical outcome is an amount which decreases or attenuates the signs or symptoms of the disease or condition being treated or abbreviates the duration of the disease or condition in the subject being treated (e.g., accelerates wound healing) when compared to a subject who has not received such treatment.
  • Suitable effective amounts or parameters associated with high-fluency, intense pulsed light which achieve the desired effect are disclosed herein and can vary with the disease or condition and the patient being treated.
  • an immune response is stimulated.
  • an immune system is suppressed.
  • such methods produce little or no permanent injury or damage to nearby skin tissue.
  • Diseases or conditions of the skin which can be treated using a high-fluency, intense pulsed light source include, but are not limited to wounds, burns, psoriasis, eczema (neurodermitis) , viral warts, precancerous solar keratosis or skin lesions, skin ulcers (diabetic, pressure, venous stasis), and the like.
  • the high-fluency, intense pulsed light source as disclosed herein is combined, either serially or simultaneously with another light or wavelength source (e.g., laser or radiofrequency) to carry out the therapeutic methods disclosed herein.
  • the high- fluency, intense pulsed light source and other light or wavelength source can be used together to work synergistically, or combined, wherein each has its own effect.
  • Suitable parameters for radiofrequency include a fluence in the range of about 0.5 J/cm 2 to about 500 J/cm 2 ; a wavelength in the range of about 300 nm to about 1200 nm; a frequency in the range of 500 kHz to 300 MHz; and a spot size in the range of 1 mm 2 to 10 cm 2 .
  • Example 2 High-Fluency, Intense Pulsed Light Method
  • a stencil was placed on the back of the pigs to treat the same surface every time.
  • the pigs underwent general anesthesia for 15-30 minutes (5 times for the treatment and 5 times for the biopsies) .
  • a VASCULIGHTTM system with 590 and 695 nm filters and a QUANTUMTM system with 565 and 640 nm filters were used. Pulse times were 6.5 to 21 milliseconds and the fluence was 35 to 60 J/cm 2 .
  • An entire surface of 40 x 2.8 cm 2 was treated per pig.
  • the treatment took 4 to 5 minutes with an interval of 4 weeks between treatments.
  • Treatment regimes are listed in Table 1.
  • Biopsies were performed immediately following light treatment and again on the second, seventh, fourteenth and twenty-eighth post-operative day. In the second month, one week after the last biopsy, the pigs were radiated again and after 3 weeks biopsies were performed. This was continued for four months. A total amount of 240 biopsies were thus taken. Full-thickness, 3-mm punch biopsies were obtained from each treated site. Tissue specimens were fixed in formalin, embedded in paraffin, sectioned and stained with hematoxylin and eosin for light microscopic examination.
  • Pigs were followed daily during the first week. After that they were seen and evaluated after 1, 2, 3, 6, 12, and 30 weeks. They were examined for presence of crust formation, swelling, bleeding, erythema, wound healing, scar formation, depigmentation and loss of hair. Photographs were taken before and after treatment.
  • Example 3 Immunohistochemistry Tissue blocks of pig skin biopsy were fixed in 4% neutral-buffered paraformaldehyde at 4°C for 4 to 12 hours. The specimens were then routinely processed for paraffin embedding at 56 0 C. Paraffin sections measuring 4 ⁇ m were used for light microscopy and immunohistochemical analysis. Paraffin sections were deparaffinized and rehydrated. Immunohistochemical demonstration of tenascin and TGF- ⁇ antigens was performed on these sections with the avidin- biotin peroxidase (ABC) method.
  • ABS avidin- biotin peroxidase
  • controls included omission of the primary or secondary antibody which resulted in negative staining and the use of human placenta as positive control for tenascin and TGF- ⁇ l antibodies .
  • the data is presented as contingency tables to detect association between technical and clinical parameters.

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Abstract

L'invention concerne l'utilisation d'une source lumineuse pulsée intense à fluidité élevée aux fins d'induction de l'expression de TGF-ß dans des cellules de la peau, une libération de protéines de matrices extracellulaires, telles que la ténascine, et une augmentation de la concentration de fibroblastes et de plasmocytes étant ainsi obtenues. Du fait que la méthodologie de la source lumineuse pulsée intense à fluidité élevée selon l'invention produit une blessure artificielle stimulant le système immunitaire et la formation de matrices extracellulaires, l'invention concerne l'utilisation d'une source lumineuse pulsée intense à fluidité élevée seule ou conjointement avec un traitement au laser ou par radiofréquences pour un traitement dermatologique et un traitement de chirurgie plastique.
PCT/EP2006/004340 2005-05-09 2006-05-09 Methodes de traitement de la peau au moyen d'un rayonnement pulse intense a fluidite elevee WO2006119972A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016107660A1 (fr) * 2015-01-03 2016-07-07 Lenicura Gmbh Dispositif et/ou méthode pour traiter les maladies de peau, des glandes, des muqueuses, du tissu conjonctif, des nerfs et/ou du tissu cérébral

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Publication number Priority date Publication date Assignee Title
EP0320080A1 (fr) * 1987-11-13 1989-06-14 Omega Universal Limited Dispositif pour stimulation biologique de tissus
US20030023283A1 (en) * 1998-11-30 2003-01-30 Mcdaniel David H. Method and apparatus for the stimulation of hair growth
WO2003042376A1 (fr) * 2001-11-15 2003-05-22 Photothera, Inc. Procedes de preparation de cartilage artificiel
WO2004033040A1 (fr) * 2002-10-07 2004-04-22 Palomar Medical Technologies, Inc. Appareil de photobiostimulation
US20060079947A1 (en) * 2004-09-28 2006-04-13 Tankovich Nikolai I Methods and apparatus for modulation of the immune response using light-based fractional treatment

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0320080A1 (fr) * 1987-11-13 1989-06-14 Omega Universal Limited Dispositif pour stimulation biologique de tissus
US20030023283A1 (en) * 1998-11-30 2003-01-30 Mcdaniel David H. Method and apparatus for the stimulation of hair growth
WO2003042376A1 (fr) * 2001-11-15 2003-05-22 Photothera, Inc. Procedes de preparation de cartilage artificiel
WO2004033040A1 (fr) * 2002-10-07 2004-04-22 Palomar Medical Technologies, Inc. Appareil de photobiostimulation
US20060079947A1 (en) * 2004-09-28 2006-04-13 Tankovich Nikolai I Methods and apparatus for modulation of the immune response using light-based fractional treatment

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2016107660A1 (fr) * 2015-01-03 2016-07-07 Lenicura Gmbh Dispositif et/ou méthode pour traiter les maladies de peau, des glandes, des muqueuses, du tissu conjonctif, des nerfs et/ou du tissu cérébral
US20170340385A1 (en) * 2015-01-03 2017-11-30 Lenicura Gmbh Device and/or Method for Treating Diseases of the Skin, Glands, Mucosae, Connective Tissue, Nerves and/or Horny Tissue
US11497553B2 (en) 2015-01-03 2022-11-15 Lenicura Gmbh Device and/or method for treating diseases of the skin, glands, mucosae, connective tissue, nerves and/or horny tissue

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