Research
Materials and Methods
40 Subjects, Males and females between 35 to 80 years of age of good general health not nursing or pregnant with demonstrable fine or deep wrinkles in the face, including around both eyes, at least barely visible dark areas, and at least slightly coarse and grainy lower eyelids.
Subjects with any active or any history of skin disease affecting the face area or under the eyes were not included. In addition, subjects were asked to stop their current regime of using any products that may enhance skin condition and aid in reduction of wrinkles. Make-up and sunscreens were permitted. Subjects who have undergone cosmetic surgery affecting facial skin within 6 months, were also excluded from the study.
Treatment Regimen
Vital Technologies Skin Serum was applied twice a day, in the mornings and evenings to clean facial skin, including the peri-orbital skin area over a period of six weeks (42 days). Subjects were asked to document each application of Skin Serum.
Clinical Assesment
Photography under standardized conditions. Clinical assessment of skin quality, including the peri-orbital skin using 1- to 10-point visual scoring system
Self Assessment
Quality of facial skin, including the periorbital skin by subject using questionnaire given
Subjects were studied independently by a contract manufacturer. Results were tabulated using scores generated by the clinical evaluations and subject questionnaire. All results showed a statistical significant of p < 0.05.
Tolerance
100% reported to have tolerated the Skin Serum well.
Texture
100% of subjects liked the way the Skin Serum felt.
Future Use
100% would continue its regular use after the six weeks study period.
No allergic responses or other adverse events were observed or reported in these studies, or in a Phase IV post market study of over 100 subjects.
Improvement is shown as difference between the averaged score before (baseline) and the averaged score after treatment expressed in percentages of the averaged baseline score and includes all 40 subjects completing the study.
Before Treatment Rating
Clinical – 5 Points
Self-Assessment 4.5 Points
After Treatment Rating
Clincal – 7.5 Points
Self-Assessment – 8.5 Points
Facial and Peri-Orbital Human
Objective
A comparison study was done to measure the results of applying Vital Serum and 5 other products of similar properties or claiming similar properties on the human skin.
This study served two purposes:
- to show how effective BRS Skin Serum is compared to other products in the market.
- Be used as a control group for the study in addition to using a placebo.
Subjects were studied independently by a contract manufacturer. Results were tabulated using scores generated by the clinical evaluations and subject questionnaire. All results showed a statistical significant of p< 0.05.
Improvement is shown as a percentage difference between the comparable products average result and Vital Serum after the treatment and includes all 40 subjects completing the study.
Vital Serum showed a 31% or better score than five other state-of-the-art products on the market.
Materials and Methods
The S²RM used in the Skin Serum has been applied to 10 human eyes. Two applications were performed on each subject for a two week period.
Clinical Assessment
Effect on corneal tissue was measured by eye exam and fundus Photography and slit lamp analysis.
Self Assessment
Corneal tissue sensitivity by subject using questionnaire given.
Results
No irritation reported, nor any cytotoxic effects as reported by eye exams including fundus photography and slit lamp analysis(e.g. edema and morphological deformity) of the corneal tissue.
In-Vitro Human Tissue Test
Materials and Methods
In-vitro tissue cultures for the growth of tissues or cells separate from the organism.These cells may be cells isolated from a donor organism, primary cells, or a cell line.
Procedure
Cell replication lapses of 2 Months in the presence of S²RM.
Results
No morphological or functional abnormalities in the cells during culture and replication periods of 2 months in the presence of S²RM.
S²RM Skin Serum Post Market Study
Background
Over 2000 adults have purchased the Skin Serum from the manufacturer’s website since 2010. A 100% Money Back guarantee has been offered since the release of the product to the market. Out of the 2000 subjects purchasing the product, 100 were selected for a efficacy and safety study.
Mass Market Results
Out of the over 2000 buyers, only one buyer has returned the product and reported a malfunction of the bottle’s pump as the cause of the return.
Efficacy and Safety Results
No adverse effect was reported during continuous use of the product.
Conclusions
The present study demonstrated that a Skin Serum containing a proprietary mixture of human stem cell derived growth factors and cytokines, and other factors is safe and efficacious for facial skin rejuvenation in cases of mild to moderate skin aging.
The serum’s efficacy, excellent tolerability, including the delicate periorbital skin area, and ease of use and pleasant sensory properties of the product explain why 100% would continue regular use of the Skin Serum from BioRegernative Sciences Inc.
Animal, human, phase IV post market, and in vitro studies also demonstrate the safety and efficacy of the
product.
References
[1] Goldberg R.A. et al., Plast Reconstr Surg 2005; 115: 1395-1402.
[2] Epstein J.S., Arch Facial Plast Surg 1999; 1: 303-307.
[3] Maguire, G. 2007: BioRegenerative Sciences, Inc. White Paper
Maguire, G. and Friedman, P. (2011) Stem Cell-Based Systems Biology Approach For Developing Therapeutics To Manage Peripheral Pain. Society for Neuroscience Annual Meeting.
Maguire, G. and Friedman, P. (2012) Stem cell released molecules (S2RM) and the paracrine and autocrine actions of stem cells. Invited paper: Stem Cell International. December 2012.
[4] Gold M.H., Goldman M.P. and Biron J., J Drugs Dermatol 2007, 6:1018.
[5] Manaloto R.M.P. and Alster T.S., Dermatol Surg 1999; 25: 1-9.