Light Therapy: from theory to manufacturing

Economic and health benefits of novel light therapies for the treatment of skin conditions

This research undertaken by Swansea University and its companies pioneered this market in partnership with Procter & Gamble and Unilever; and established a joint venture with Sony UK to manufacture these laser and IPL products in South Wales. The Welsh government views this collaboration as an exemplar for the resurgence of UK specialist manufacturing.

 Research into the use of light energy to treat skin conditions began at Swansea University in 2000 with the appointment of Prof Marc Clement to the Department of Electrical Engineering and subsequently the Medical School. The research has contributed to the development of light-tissue science and treatments for many debilitating and distressing skin conditions (including acne, aging or sun-damaged skin, hirsutism, wound healing, pigment disorders, and cellulite or stretch marks).

When the research at Swansea University began, light therapy was already being used to treat cervical cancer and to reduce tumours. The therapy consisted of thermal vaporisation of tissue and had been shown to produce a degree of therapeutic benefit, particularly in the treatment of cervical cancer. However, these approaches did not use all the attributes of laser light, including coherence and monochromaticity. Clement began his research in 2000 by consulting clinical experts, including dermatologists, to understand the target physiology and to hypothesise a mode of action of light for each skin condition. A subsequent programme of computer-based predictive modelling from 2002 led to the characterisation of optical light parameters including wavelength, energy, and temporal and spatial profiles designed to engender the hypothesised mode of action – for acne in the first instance. This modelling was essential as specific wavelengths in the visible spectra differentially penetrate the skin and target discrete structures to mediate the desired effect. A laboratory programme was implemented in vitro and ex vivo to optimise the optical light parameters and enhance general understanding of biological mechanisms in the development and treatment of acne. Experimental treatments for acne included using specific frequencies of light to initiate a wound-healing cascade in the skin while targeting the naturally occurring photosensitive structures within the acne bacteria. A similar approach was used to study other skin conditions to show that light treatment for skin rejuvenation targeted oxyhaemoglobin in the blood to initiate a wound-healing response that led to enhanced local collagen production. Then suppression of hair growth was achieved by targeting melanin within the hair shaft and raising the temperature of local hair follicle stem cells leading to their denaturation.

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Each of the laser and IPL products developed had to undergo clinical trials to demonstrate efficacy and safety to a range of stakeholders – including global regulators, strategic market partners, investors, users, and the general public. This was achieved through ethically approved multi-centre clinical trials coupled with human factor studies for consumer use (skin rejuvenation trials 2000-3; acne trials 2001-3; hair removal trials 2005, 2008 & 2011-2; followed by acne, skin rejuvenation and hair removal studies for FDA approval 2010-1). Swansea researchers led trials in the UK, USA, Europe, India and Japan that confirmed efficacy and safety, informed product development and led to 12 product approvals by the US Food and Drug Administration [e.g. R5], as well as ISO registration under the medical device directive (ISO 13485) with 4 CE approvals for the UK and Europe (including 60335 for household and similar appliances and 62233 for domestic use). The Swansea University team’s inter-disciplinary research continues to combine laser tissue modelling, innovative system design and testing of hypothesised mode of action, culminating in the design of efficacious laser and IPL products as confirmed in clinical trials. Most recently our spin-off company, Cyden Ltd, has miniaturised the technology for home-use markets that are traditionally harder to access and has now reached over 40 countries. Clement and his team of research fellows and students have recently extended their research to characterise the process of adapting proven technologies to emerging countries for both clinical use and economic development [R6].

 This research undertaken by Swansea University and its companies pioneered this market in partnership with Procter & Gamble and Unilever; and established a joint venture with Sony UK to manufacture these laser and IPL products in South Wales. The Welsh government views this collaboration as an exemplar for the resurgence of UK specialist manufacturing.

References 

  1. Patel N, Clement RM. Selective non-ablative treatment of acne scarring with 585 nm flashlamp pulsed dye laser. Dermatol. Surg. 2002; 28: 942-5.
  2. Seaton ED, Charakida A, Mouser PE, Grace I, Clement RM, Chu AC. Pulsed-dye laser treatment for inflammatory acne vulgaris: randomised controlled trial. The Lancet 2003; 362: 1347-52.
  3. Bjerring P, Clement RM, Heickendorff L, Egevist H, Kiernan M. Selective non-ablative wrinkle reduction by laser. J. Cutan. Laser Ther. 2000; 1: 9-15.
  4. Allison KP, Kiernan MN, Waters RA, Clement RM. Evaluation of the ruby 694 Chromos for hair removal in various skin sites. Lasers Med. Sci. 2003; 18: 165-70.
  5. Food & Drug Administration. Approval to Cyden Ltd to market IPL iPulse i150 System laser surgical instrument for use in general and plastic surgery. Rockville MD: Department of Health & Human Sciences; 2 February 2009. http://www.accessdata.fda.gov/cdrh_docs/pdf8/K083748.pdf.
  6. Doneddu D, Hussain A, Clement RM. A new paradigm to accelerate the transformation of resource-rich nations into sustainable knowledge economies. Intl J. Knowl. Innov. Entrep. 2013; 1: 117-42. http://tinyurl.com/o9spkyp