S K I N   C A N C E R   &   P H O T O D Y N A M I C   T H E R A P Y  [PDT]

PDT is an attractive method of treating skin cancers without surgery and with excellent results aesthetically, but its widespread implementation has been held up by high costs. The specialised light sources required were very expensive and could not be used for anything else. Swiss companies ave taken the lead in non-laser phototherapy and Q.Products AG makes the largest range of flexible and specialised non-laser devices. The flexible model for medical professionals who require a wide range of treatment options now has the capability to deliver the correct wavelengths of red, incoherent polarised light necessary to activate photosensitising creams such as Metvix® for PDT and also has a blue diagnosis filter which is used with a revealing cream to help identify lesions. There is also a new dedicated model for skin cancer specialists.

Q.Light PRO

Q.Light PRO is a modular device using filter modules of different characteristics to treat a wide range of medical conditions.

With the new diagnosis and PDT treatment filter modules this reduces the cost of PDT equipment substantially, making treatments more viable financially.

* Diagnosis: blue light 385-450nm
* PDT Treament: red, incoherent polarised light, 620 - 780nm

Other optional filter modules allow phototherapy treatments of dermatological conditions, e.g. psoriasis and acne, acute or chronic wounds and further conditions (see pages from this web site). Together these make Q.Light PRO a highly attractive and flexible device for dermatologists and skin cancer specialists with the capability of taking on new functions as required.

Choice of stands
Clinics, surgeries and practitioners operating in confined spaces can use the neat and sturdy Regular stand, with five casters for stability (with brakes for smooth floors), an adjustable arm and swivel ball joint for the head. This allows a great variety of positions and angles for the head whilst taking up very little valuable floor space.

Hospitals and larger clinics, especially those where over-bed use is desired will appreciate the PRO-Plus stand with extended cantilever arm and extra storage (additional lower shelf and storage basket not shown).

Product features

Polarised light radiation with power density of approx. 40 mW/cm² at maximum recommended treatment distance 40cm for most medical treatments, giving max. 40cm diameter coverage.

For PDT: 70mW/cm² (4.2J/cm²) at maximum recommended treatment distance 16.5cm with treatment diameter 16.5cm
Four aperture settings.
Inbuilt timer and multifunction display.
CE marked medical product, complying with Guidelines for Medical Products 9342 EWG and DIN EN ISO 13485:2003

Q.Light PDT

Q.Light PDT is a specialised model developed for skin cancer specialists and comes complete with the Diagnosis and PDT Treatment filter modules described above.

It can be used on the same choice of stands and also on the lightweight folding Home stand (see Q.Light Accessories page), however this is only recommended where portability is an important requirement. Q.Light PRO cannot be used on the Home stand.

Maximum treatment diameter 15cm.

Q.Light PDT has a simple on/off control.

Download the fact sheets for further information

Q.Light for Skin Cancer and PDT (features Q.Light PRO and includes Testimonials)
Q.Light for Psoriasis and Dermatitis (includes Treatment Guide)
Q.Light for Medical Professionals (includes Treatment Guide)
Q.Light PDT (in German only)
Overview of the Q.Light Range

To make a purchase or other enquiry please complete the form below.

The Q.Light® PRO is an attractive alternative to dedicated PDT light sources. The system and filter modules offer interchangeable diagnosis and treatment filters for PDT and a wide range of proven medical therapies using different light frequencies in a flexible and upgradable package.

Photodynamic Therapy [PDT] filter modules

PDT Diagnosis     Blue light 385-480nm for diagnosis.
PDT Treatment    Red incoherent polarised light 62-780nm: delivers 70mW/cm2 [4.2 J/cm2] at max treatment distance 16.5cm with treatment diameter 16.5cm.

The development of the PDT Treatment filter module has been based upon successful research into photodynamic therapy and,since 2004, upon clinical licensing from Metvix®. It has been
especially developed for Dermatologists and complies with regulations for medical products as set out in the Guidelines for Medical Products 93/42 EWG, also it has certification status based on the international standards and requirements for regulatory purposes of DIN EN ISO 13485:2003.

For optimal therapeutic effect a source of red, incoherent light is required (Szeimies et al. 1996; Fijan et al. 1995). Q.Light® PRO with the PDT Treatment filter module emits red, incoherent light in the spectrum from 620nm to 780nm. In accordance with the table below, this products light treatment times of between 13 and 45 minutes with the median time of approx. 25 min.

Indication for PDT in Dermatology:

C l i n i c a l   d e c i s i o n   m a k i n g
Nice [National Institue for Clinical Excellence - UK] has examined the use of PDT for use in dermatology for the treatment of skin cancers. To view both their summary and detailed discussion document please follow the following link to their site CLICK HERE

Summary of NICE review on clinical application:

Interventional Procedures Consultation Document - Photodynamic therapy for non-melanoma skin tumours (including premalignant and primary non-metastatic skin lesions) NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE    www.nice.org.

Hospitals Offering Various Forms of PDT Therapy

 

Interventional Procedure Consultation Document

Photodynamic therapy for non-melanoma skin tumours (including premalignant and primary non-metastatic skin lesions)

The National Institute for Health and Clinical Excellence is examining [ as of 2005] photodynamic therapy for photodynamic therapy for non-melanoma skin tumours (including premalignant and primary non-metastatic skin lesions). It will publish guidance on its safety and efficacy to the NHS in England, Wales and Scotland. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about photodynamic therapy for non-melanoma skin tumours (including premalignant and primary non-metastatic skin lesions).

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

comments on the preliminary recommendations the identification of factual inaccuracies additional relevant evidence. Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation. The Advisory Committee will then prepare draft guidance which will be the basis for the Institute's guidance on the use of the procedure in the NHS in England, Wales and Scotland. For further details, see the Interventional Procedures Programme manual, which is available from the Institute's website (www.nice.org.uk/ipprogrammemanual).

Closing date for comments: 22 November
Target date for publication of guidance: February 2006

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation.
1 Provisional recommendations

1.1 Current evidence suggests that there are no major safety concerns associated with photodynamic therapy for non-melanoma skin tumours (including premalignant and primary non-metastatic skin lesions).

1.2 Evidence of efficacy of this procedure for the treatment of basal cell carcinoma, Bowen's disease and actinic (solar) keratoses is adequate to support its use for these conditions, provided that the normal arrangements are in place for consent, audit and clinical governance.

1.3 Evidence is limited on the efficacy of this procedure for the treatment of invasive squamous cell carcinoma. Recurrence rates are high and there is a risk of metastasis. Clinicians should ensure that patients understand these risks and that retreatment may be necessary. In addition, use of the Institute's Information for the public is recommended.

2 The procedure

2.1 Indications

2.1.1 Non-melanoma skin tumours include basal cell carcinoma, squamous cell carcinoma, Bowen's disease and actinic (or solar) keratoses.

2.1.2 Basal cell carcinoma is the most common form of skin cancer. It is generally a slow-growing, locally invasive epidermal skin tumour that rarely spreads to other distant parts of the body. Although it is not usually life threatening, the tumour can cause extensive tissue destruction if it is not treated adequately. Squamous cell carcinoma is the second most common type of skin cancer in the UK. It arises from cells in the epidermis and spreads into the surrounding skin. It can also spread to nearby lymph nodes and may be life threatening in rare cases. Bowen's disease is an early form of non-melanoma skin cancer. If untreated, it can progress to invasive squamous cell carcinoma. Actinic keratoses are small lumps of hard skin that are usually harmless but have the potential to develop into squamous cell carcinoma.

2.1.3 Current treatments for basal cell carcinoma include topical chemotherapy, curettage, surgical excision, cryotherapy and radiotherapy. Squamous cell carcinoma is usually removed surgically. Bowen's disease and actinic keratoses are usually treated with curettage, cryotherapy or topical chemotherapy.

2.2 Outline of the procedure

2.2.1 In photodynamic therapy (PDT), the lesion is prepared by removing overlying crust and scale. A photosensitising agent is applied to the lesion and a margin of surrounding skin. The lesion is illuminated by light of an appropriate wavelength to activate the photosensitiser, producing targeted tumour destruction. Occasionally, the photosensitising agent may be given intravenously. More than one lesion may be treated in a session and the treatment can be repeated.

2.3 Efficacy

2.3.1 One randomised controlled trial (RCT) of patients with basal cell carcinoma reported that there was no statistically significant difference in lesion clearance between PDT and surgery (91% [48/53] and 98% [51/52] of patients respectively). Another RCT reported that 25% (11/44) of patients had a positive biopsy at 12 months after PDT compared with 15% (6/39) of patients after cryotherapy (p > 0.05). Both of these studies reported statistically significantly better cosmetic outcomes after PDT than after the comparator.


2.3.2 Two RCTs compared PDT and cryotherapy in patients with actinic keratosis. One reported a similar lesion clearance rate for PDT and cryotherapy (69% [252/367] and 75% [250/332] respectively) whereas the other reported a clearance rate of 91% (267/295) for lesions treated with PDT at 3 months, compared with 68% (278/407) of lesions treated with cryotherapy (p < 0.001). Both studies reported that cosmetic outcomes were good or excellent in a significantly higher proportion of patients after PDT.

2.3.3 A case series of 59 patients with basal cell carcinoma reported that the overall cure rate was 79% (277/350) of lesions after a mean follow-up of 35 months. For more details refer to the Sources of evidence (see Appendix).

2.3.4 The Specialist Advisors stated that there were some concerns about recurrence rates and that the treatment may be more appropriate for large, superficial lesions of Bowen's disease, actinic keratosis and basal cell carcinoma, especially where there are multiple lesions and where repair would otherwise require extensive surgery.

2.4 Safety

2.4.1 Adverse events were mainly transient local reactions. Three studies reported that the total rate of adverse events ranged from 43% (44/102) to 90% (38/42) of patients. The most common complication was a burning sensation of the skin, and this affected between 31% (16/52) and 64% (27/42) of patients. Two studies reported ulceration rates of 0% (0/20) and 12% (5/42) respectively. One large case series reported minor pigmentary changes and superficial scarring each in 2% (10/483) of lesions. Other adverse events included pain, erythema, crusting, itching, oedema and blisters. For more details refer to the Sources of evidence (see Appendix).

2.4.2 The Specialist Advisors stated that the procedure is generally safe and well tolerated. It is theoretically possible that the treatment could induce carcinogenicity but this is likely to be a low risk.

2.5 Other comments
2.5.1 The Committee noted that there are a variety of agents and treatments used.

2.5.2 The Committee also noted that results may vary depending on the conditions being treated, and that a Cochrane review is being developed on photodynamic therapy for localised squamous cell carcinoma of the skin and its precursors.
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
November 2005

Appendix: Sources of evidence

The following document, which summarises the evidence, was considered by the Interventional Procedures Advisory Committee when making its provisional recommendations.

Interventional procedure overview of photodynamic therapy for non-melanoma skin tumours (including premalignant and primary non-metastatic skin lesions), April 2005

Available from: www.nice.org.uk/ip272overview

Protecting yourself against melanomas

Although we're not sure exactly what causes melanomas, we do know that the sun plays a big part. So to protect yourself and your family against melanomas you need to stay out of strong sunlight and do things to stop it damaging your skin.

It's impossible to avoid the sun all the time. So when you go out in the sun you need to cover up. You can do this by wearing clothes that cover you up or by using sunscreen.

Although there's no research proving that sunscreen prevents melanomas, doctors agree that you should use sunscreen. We know for certain that wearing sunscreen cuts your chances of getting a type of skin cancer called squamous cell cancer.  1 Sunscreen can also help prevent scaly red spots called solar keratosis that can become cancerous.  2 Sunscreen may protect you against melanomas too.

The part of sunlight that has a role in skin cancers is ultraviolet (UV) light. There are two types of UV light: UV-A and UV-B.3

Here's what you can do to protect yourself against the sun.

• Choose a sunscreen that protects against both UV-A and UV-B rays.
• Use a sunscreen that has a sun protection factor (SPF) of 15 or more.
• Spread the sunscreen evenly on any skin that will be in the sun.
• Put sunscreen on 15 minutes before you go out.
• Apply more sunscreen every 30 minutes and after you've been swimming or sweating a lot.
• Use enough sunscreen. To get the right amount, use the 'two-finger rule'. Squeeze out sunscreen along the length of your first two    fingers. Use this much sunscreen on each of these parts of your body: your head, neck and face; each arm; upper back; lower        back; chest; stomach; each upper leg (back and front); and each lower leg (back and front).6
• Apply more sunscreen more often when you're in the snow or in water. The sun's rays reflect off these surfaces, which means you   get more sun.
• Don't stay in the sun longer just because you're using sunscreen. You are still exposing yourself to dangerous rays and can still   get burned.
• Stay out of the sun when it's at its hottest. This could be as long as between 10 a.m. and 4 p.m. if you're staying in a hot country.
• Wear a hat.
• Wear long-sleeved tops and trousers or a long skirt or dress.
• Wear sunglasses. These will protect your eyes and the skin around your eyes.
• Don't use sunbeds. Sunlamps in sunbeds give off mostly UV-A rays, and these may play a part in causing skin cancer.
• Make sure you take extra care with children's skin. Children and teenagers are more likely to spend a long time in the sun, so it's   important to take special care of their skin. People who get sunburnt a lot as children are more likely to get melanoma when they   get older.

Sunscreen is unlikely to be harmful. But babies under 6 months old should be kept out of the sun because their skin is very sensitive, and sunscreen may give them a rash. Source: NHS Direct http://www.besttreatments.co.uk/btuk/conditions/13565.html

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