A Prospective Multicenter Study to Evaluate the Safety and Efficacy of the Topical Application of MYOWNN™, an Autologous Growth Factor Concentrate (AGFC) Serum, in Anti-Aging.

Background Growth factors from platelets have been emerging as a revolutionary treatment with the ability to induce cell growth in the skin, which results in retarding and reversing the aging process. Platelet-rich plasma (PRP) allows for greater release of growth factors and biologically active proteins, which in turn activates the cascade of stimulation of neoangiogenesis and collagen production. PRP is used in anti-aging and facial skin rejuvenation in the form of dermal injections and topical application during micro-needling. This study was conducted to assess the safety and efficacy of a topically applied face serum, MYOWNN™ (Wockhardt Ltd., Mumbai, India). MYOWNN™ is an autologous growth factor concentrate that has been made into a topical face serum. Methods Male and female subjects in the age group between 30 and 55 years (both inclusive) with Fitzpatrick skin type III-V who had not taken any oral or topical treatments for at least four weeks before and any platelet-rich plasma (PRP) based facial treatment (injections) at least six months before the study entry were included. MYOWNN™ serum was applied on the face once daily at night, approximately 30 minutes before sleeping preferably, for a total duration of five months. Six parameters, i.e. spots, pores, wrinkles, texture, moisture, and pigmentation, were evaluated at regular intervals with Visage-LS (dermaindia®, Tamil Nadu, India), a face analysis system that gives the live status of these six parameters and is an advanced live status skin detection equipment together with shooting, analyzing, and displaying functions, as well as the subjective analysis, was performed by subjects and physicians using different globally accepted scales like physician's global aesthetic improvement scale (PGAIS), subject's global aesthetic improvement scale (SGAIS), subject satisfaction score (SSS), and wrinkle severity rating scale (WSRS). For analysis, a mixed model for repeated measures was used. The model had change from baseline as the dependent variable visit as a factor and baseline assessment result as a covariate. All primary and secondary efficacy endpoints were analyzed using Modified Intent-to-Treat (mITT) populations. Results Improvement in an average of six anti-aging parameters was observed as early as three months while statistically significant improvement was observed by the end of five months of application. A statistically significant improvement in wrinkles was observed by the end of three months of the application itself. There were no product-related adverse events reported. Conclusions Five months of application of MYOWNN™ serum showed a statistically significant improvement in an average of six parameters of anti-aging and face rejuvenation with a p-value of 0.0150 (<5% level of significance (i.e. 0.05) and was also well-tolerated.

Assessment of wound healing efficacy of Growth Factor Concentrate (GFC) in non-diabetic and diabetic Sprague Dawley rats.

BACKGROUNDS: The investigation of wound healing potential of human GFC (growth factor concentrate) was undertaken in diabetic and non-diabetic rats. Primarily, GFC is the combination of several growth factors present in blood which has potential of wound healing. In present study, WCK-GFC kit, a single step optimized kit was used for obtaining human GFC. METHODS: Diabetes in rats was induced by intraperitoneal single injection of 40 mg/kg streptozotocin (STZ). The full thickness circular wounds of 2 cm2 area were created using sterilized stainless steel biopsy punch. Non-diabetic wounds were topically treated with 100µL and 300µL of GFC, while diabetic wounds were treated with 300µL of GFC. The standard of care treatment groups were included, wherein the non-diabetic and diabetic wound were topically treated with Nadoxin and Z-AD-G skin cream, respectively. The percentage of wound contraction was measured on weekly intervals. At the end of study duration, tissues from wound were collected for histopathological evaluation. RESULTS: Both diabetic and non-diabetic GFC treated rats exhibited a significantly higher rate of wound contraction on day 8 and 15 compared to normal untreated control group and standard-of-care treated rats. Wound healing was induced by GFC through rapid re-epithelialization. On comparing wound healing with standard-of care agent, the GFC treated wounds demonstrated a faster remodeling phase, a better organization and lower inflammation. CONCLUSIONS: The current study demonstrates that topically applied GFC promotes healing of wounds, with enhanced wound contraction in both non-diabetic and diabetic rats.