European Laser TrEAtment Dermatology (LEAD) registry

Dr Albert Wolkerstorfer

European Laser TrEAtment Dermatology (LEAD) registry

Dr Albert Wolkerstorfer

Lasers in dermatology

Lasers are considered the treatment of choice for some cosmetic conditions and a limited number of skin disorders. However, hundreds of skin disorders have been reported to improve after laser therapy. This group of non-cosmetic skin disorders is highly varied, including skin disorders such as malformations, tumours, inflammatory disorders, pigmentary disorders, vascular disorders, hair follicle related disorders, genodermatoses, and even some infections. Many of these disorders meet the criteria of an orphan disease.

The problem

For most of these treatments evidence for efficacy is lacking. Many of these skin disorders are uncommon or even extremely rare, making larger studies particularly challenging. Moreover, laser
companies have no financial interest to support studies for these non-cosmetic indications and laser conferences focus almost entirely on cosmetic indications. Only occasionally, certain non-cosmetic indications such as port wine stains or congenital nevi are a topic at laser conferences. The current evidence is insufficient to provide clinicians with guidance and details of the optimal laser regimen for nearly all the potential noncosmetic indications for lasers.

The need to provide evidence for the efficacy of laser treatments

As a result of the lack of evidence, the benefit of lasers in the treatment of many skin disorders remains unclear. For patients, this lack of evidence results both in overtreatment (patients who receive ineffective laser treatments) and undertreatment (patients who do not receive potentially effective laser treatment). urthermore, physicians have the ethical responsibility to provide evidence for unproven interventions.

This is expressed clearly in the Declaration of Helsinki from the World Medical Association. The last paragraph “Unproven Interventions in Clinical Practice” states the following:

“In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. This intervention should subsequently be made the object of research, designed to evaluate its safety and efficacy. In all cases, new information must be recorded and, where appropriate, made publicly available.”

This paragraph of the Helsinki Declaration expresses perfectly the necessity for a registry in cases where controlled studies are not feasible.


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