The registry is envisioned to suit all types of laser interventions for skin disorders in dermatology including vascular, pigmented or inflammatory lesions, benign tumours and hair follicle-related skin conditions. The GOS is intended for use in the LEAD registry, with the focus on prospectively recording the effectiveness and safety of cutaneous non cosmetic laser interventions. Although the term cosmeceutical is ambiguous in dermatology literature and dominating academic discussions, we excluded body contouring, skin tightening, hair removal, rejuvenation and anti-aging procedures. Furthermore, because of the distinctive mode of action and use in daily clinical practice, laser assisted drug delivery, low laser level therapy and laser procedures for leg veins were excluded.
LEAD stands for The International Laser TrEAtment Dermatology (LEAD) registry. We envision a platform that will connect the expertise of a large team of laser specialists, clinicians and researchers. This will mainly serve as a multicentre, prospective and observational registry with the focus on patients treated for any medical skin condition with any type of laser. This initiative facilitates the evaluation of the safety and clinical effectiveness of treatments in a real world setting. Eventually, the registry will be used to list all laser treatments for common and uncommon medical indications.
Scope of the intended COS
- Study types: RCTs, retrospective studies, prospective studies, case series, case reports
- Region: Europe, Africa, Asia, USA
By reviewing the literature and involvement of key stakeholder groups, involving adult patients in need or after laser surgery and health professionals with expertise in laser treatments, a preliminary list of outcome domains and domain items will be generated. Using the outcome domains generated from a literature review and input of stakeholders, an international three-round Delphi study will be performed to rate the importance of outcome domains in the selection of a GOS. Participants are allowed to provide additional suggestions for revisions or new outcome domains to the proposed list during the first Delphi round. Finally, results will be discussed during a consensus meeting to agree on generic outcome domains to be used in the LEAD Registry.
Involvement of stakeholders
- Patients of age >18 including vascular, pigmented, inflammatory, metabolic, infectious lesions, benign tumours and hair follicle-related skin conditions treated by lasers.
- Patient representatives involved in patient associations that raise awareness on the impact of vascular, pigmented or inflammatory lesions, benign tumours and hair follicle-related skin conditions.
- Health care professionals – Laser experts who treat patients with vascular, pigmented or inflammatory lesions, benign tumours, hair follicle-related skin conditions and who are involved in research on laser treatments.
- Health care professionals –General physicians who treat patients with dermatological indications.
The identification of core outcomes for registry use is ongoing and in the initial phase. A systematic review has been performed to explore current outcome domains used and reported in laser dermatology. We are currently preparing to recruit participants to the Delphi study. The generic outcome domains are expected to be implemented in the laser registry in 2020.
European Academy of Dermatology and Venereology (EADV Project proposal reference number 2017-035).
The Netherlands, Denmark, Egypt, France, Germany, Israel, Italy, Japan, Spain, Switzerland, Thailand, USA.
Date of updates
- Frederike Fransen (the Netherlands)
- Albert Wolkerstorfer (the Netherlands)
- Phyllis Spuls (the Netherlands)
Project team members
- Murad Alam (US)
- Ashraf Badawi (Egypt)
- Pablo Boixeda (Spain)
- Iltefat Hamzavi (US)
- Merete Haedersdal (Denmark)
- Lene Hedelund (Denmark)
- Kristen Kelly (US)
- Taro Kono (Japan)
- Hans-Joachim Laubach (Switzerland)
- Woraphong Manuskiatti (Thailand)
- Leonardo Marini (Italy)
- Keyvan Nouri (US)
- Uwe Paasch (Germany)
- Thierry Passeron (France)
- Sanna Prinsen (The Netherlands)
- Ines Verner (Israel)
Responsible member of Methods group (as assigned by CS-COUSIN)
- Dr. Jan Kottner
Frederike Fransen (the Netherlands)
Amsterdam UMC, Department of Dermatology, 9, 1105 AZ, Amsterdam, the Netherlands.
Albert Wolkerstorfer (the Netherlands)
Amsterdam UMC, Department of Dermatology, 9, 1105 AZ, Amsterdam, the Netherlands