CLINICAL SUMMARY

A study has been conducted to evaluate the efficacy and safety of a growth factor based skin solution in adjunction with a micro-channeling procedure for providing anti-ageing and anti-wrinkle benefits in healthy subjects.

Introduction
There are currently many products that claim to be effective treatments of the signs of ageing. With the growing acceptance that treatments exist to treat the signs of ageing many people are also opting for more aggressive, in clinic treatments such as laser, micro-channeling and plasma treatment etc. There is also a resultant trend towards more advanced treatments at home as a follow up to clinical treatment. This is the rationale for the treatment protocol in this study which combines The EMPRESS Micro Fusion Applicator and BioActive SKINGENUITY Regenerative PolyGF Solution.
The use of growth factors is becoming more established as a way of improving the signs of ageing. The use of regenerative techniques and in particular, growth factors has become more mainstream with the increased popularity of PRP and other similar treatments. One of the main issues in the increased usage of growth factor based products is that they are large molecules (more than 1500 Daltons) and will not penetrate the skin unless ‘helped’. Recent studies show that only molecules of 500 Daltons or less will penetrate the skin. In the case of the BioActive range of products, all growth factors are nano-encapsulated so that they penetrate the skin. In addition, it is postulated that the use of a concentrated growth factor solution plus local needling to the skin will be effective, for treating the signs of aging and allow a continuation of treatment from clinic to home use.

Methods and outcomes
The methods and outcomes are summarised below; 10 patients were treated according to the following protocol.
• Patient treated with EMPRESS Micro Fusion Applicator and SKINGENUITY Regenerative PolyGF Solution.
• Patient self treats twice weekly with Home use EMPRESS Micro Fusion Applicator and SKINGENUITY Regenerative PolyGF Solution.
• Patient returned every two weeks for in-clinic treatment for a total of six treatments.
The improvement in the signs of ageing was measured using: Visia analysis, 3D imaging using Antera 3D, dermatologist assessment and patient self-assessment.
Dermatological Assessment: A scale of 1-5 was used to measure the change in criteria as defined in the protocol;

Results
Improvement as measured by the change in the scale, with five being the best outcome, shows that the majority of measurements showed a significant change (in red on the below graph) over the period of the study. Using the same scales, the patient self-assessment all showed a significant improvement in the same criteria.
There was a significant improvement in wrinkles over the period of the study, with deep wrinkles showing a significant improvement.

Conclusions
Overall there was a significant improvement in all the signs of ageing that were measured apart from hyperpigmentation. Although an improvement was seen on these criteria it wasn’t significant. There were two withdrawals from the study due to lack of tolerance of the technique, but overall when the protocol was followed there were no issues with patients following the prescribed methodology.
It is therefore safe to conclude that the use of EMPRESS MF Applicator in clinic followed by the same treatment at home can provide a significant improvement in the signs of ageing and will work on severe wrinkles, as well as the mild to moderate signs of ageing.