Aesthetic dermatological products aim to alter the cosmetic appearance. They are diverse and can be found in all product categories: cosmetic products, medicinal products as well as medical devices (as devices without a medical purpose). Since the implementation of the Medical Device Regulation in 2021 more aesthetic dermatological products are now classified as devices without a medical purpose. Hence, the marketing authorization for these products must be granted in accordance with the requirements of the MDR and must therefore be based on clinical trials following ISO guidelines.
Through strategic cooperation with the dermatological practice 'Prager & Partner' we are well placed as a full-service provider to cover all categories of aesthetic dermatological products
Aesthetic dermatological products target a plethora of indications:
- Blemishes (scars, stretch marks, unwanted tattoos etc.)
- Body contour(cellulite, lipoma, muscle definition, skin laxity etc)
- Facial contour (asymmetry, volume loss/lipoatrophy, loose skin etc)
- Hair (hair thinning/loss, unwanted hair)
- Hyper-pigmentation (melasma, sun damage, birthmarks)
- Skin surface ( wrinkles/creases/folds/lines, skin roughness, dullness, dryness)
- Vascular (red vessels/ telangiectasias, redness/rosacea, blue veins etc.)
We use a variety of modern technologies to evaluate the efficacy against such indications. For example:
clinical photography, 3D imaging as well as skin profilometry in addition to unique devices (Confocal Raman Microspectroscopy, RSOM – Raster Scanning Optoacoustic
Mesoscopy etc.) as well as standard devices (Cutometer, Corneometer).
By the very nature of aesthetic dermatology, the human perception of efficacy is of central importance therefore as part of our efficacy and tolerability testing, subjective evaluations are always performed by experienced experts as well as the subjects themselves using well evaluated parameter scoring systems.
- Chemical peels
- Dermal fillers
- Wrinkle relaxers (neuromodulators such as Botox/Botulinum toxin)
- Injectables (thread lift, PRP, sclerotherapy, deoxycholic acid injection, collagenase injections etc.)
- Energy-based devices: lasers, IPL, electromagnetic, ultrasound (incl. shock waves and rapid Acoustic Pulse (RAP)), cryolipolysis, radiofrequency, cold plasma energy based devices
- Microneedling devices
- Liposuction devices