CLINICAL STUDY
CORRECT AND PREVENT VISIBLE SIGNS OF AGING
Cosmeceuticals represent the fastest-growing sector of the skincare industry, with anti-aging products driving much of this growth. Marketing claims for these products often highlight certain formulation guidelines as key to achieving healthier, more youthful-looking skin. These guidelines typically include the exclusion of potentially problematic ingredients, the inclusion of naturally-derived ingredients, and the presence of clinically proven actives at efficacious levels, often referred to as ‘medical grade.’
This study aimed to evaluate the effectiveness of a novel 3-step ‘medical grade’ skincare regimen, free from parabens, sulfates, and dyes, which combines high levels of unique actives with botanical and marine extracts. Subjects followed a 3-step regimen and were assessed at baseline and biweekly over a 12-week period using digital photography and clinical evaluation by a board-certified dermatologist.
The objective was to determine the impact of this multi-ingredient regimen on four specific skin parameters: the appearance of lines and wrinkles, redness, skin tone evenness, and skin texture. Preliminary results after 4 weeks of twice-daily use showed significant improvement in all four clinical parameters compared to baseline, with further improvements observed at 12 weeks.
1. Omission of problematic ingredients Each of the products in the test regimen were:
Sulfate Free: this claim refers to the omission of the foaming agent Sodium Lauryl Sulfate, which is associated with worsening of redness, pore appearance, and breakouts.
Paraben Free: these preservatives, widely used in topical preparations, have been associated with positive breast cancer biopsies as well as allergic contact dermatitis.
Dye Free: food coloring and naturally derived dyes used in skin care formulations have been noted to cause contact dermatitis. More often than causing a rash, these dyes can enhance facial redness that is often incorrectly attributed to other conditions like rosacea and photoaging.
2. Inclusion of special botanical and marine derived ingredients
For centuries, essential oils and plant extracts have formed the basis of a myriad of medicinal remedies proven effective in various cultures. Newer botanical and marine actives that are the result of cutting-edge extraction processes now claim remarkable rejuvenation, hydration, and skin calming benefits. Products in the 3-step test regimen incorporate chamomile and citrus essential oils, chamomile extracts, sunflower seed oil, and certified organic lilac stem cells. Also, two unique cutting-edge marine extracts from the coastal waters of France act as gene modulators to upregulate genes responsible for skin firming components including collagen, elastin, and hyaluronic acid, and to downregulate the gene responsible for synthesis of the skin aging protein, Progerin.
3. “Medical grade” actives
The term “medical grade skin care” has come to the forefront as skin care consumers turn to their physicians and skin care professionals for products they expect to be more effective than standard cosmetic company products. The distinguishing features of the medical grade products are generally high concentrations of unique, science-based actives. The present regimen incorporates active levels of Lipochroman® (the strongest* and only antioxidant that protects from both nitrogen and oxygen free radical formation), Chromabright® (a UVA/UVB photo-protective tyrosinase inhibitor that is unique in having a broad spectrum UV protective profile compared to the more popularly used fade ingredients, hydroquinone and kojic acid, both of which are UV sensitizers.), 3% tetrahexyldecyl ascorbate (a vitamin C analogue that is photoprotective against both UVA and UVB. Due to its lipophilic structure, it has superior percutaneous absorption than L-ascorbic acid, is less irritating, and is a better collagen stimulator than L-ascorbic acid).
STUY DESIGN AND PARTICIPATION
This open-label clinical trial was conducted to evaluate the effectiveness of a novel 3-step, “medical grade” anti-aging skincare regimen. The regimen was formulated to be free from sulfates, parabens, and dyes, and contained high levels of unique actives, botanical, and marine extracts. The study aimed to assess the impact of this regimen on the appearance of fine lines and wrinkles, skin tone, redness, and skin texture.
Fifteen participants, comprising 14 women and one man aged between 37 and 75 years, were enrolled in the study. Inclusion criteria required participants to have visible fine lines and/or wrinkles at baseline. Exclusion criteria included the use of other skincare products or treatments for at least one month prior to and during the study period.
Participants were instructed to use the 3-step skincare regimen twice daily for 12 weeks. The regimen consisted of a botanical cleanser, a serum containing lilac stem cells, vitamin C, and marine extracts, and a triple-action antioxidant moisturizer with Chromabright™. Participants were advised to discontinue all other skincare products but were allowed to use their usual SPF product if they were going to be outdoors.
Subjects were assessed at baseline and biweekly for a period of twelve weeks. Assessments included digital photography and clinical evaluation by a boardcertified dermatologist.
RESULTS
All participants reported good tolerance to the products throughout the 12-week study period. At baseline, all 15 participants presented with visible fine lines and/ or wrinkles. By the four-week mark, 87% of participants demonstrated a visible improvement in the appearance of lines and wrinkles. It is noteworthy that the two participants who did not show improvement at this time point were aged 70 and 75, respectively, and had very severe photodamage and deep wrinkles at baseline. However, the 75-year-old participant did show improvement at the 12-week evaluation.
DISCUSSION
This study provides compelling evidence that the use of these three specific products twice daily as part of a skincare regimen can lead to significant visible improvements in certain parameters of appearance. The inclusion of the tripleaction antioxidant Lipochroman™ is particularly noteworthy. Lipochroman™ has been demonstrated, through T-Bar Assay, to possess the highest activity against oxygen free radicals, and it is also active against carbon and nitrogen free radicals. Given that nitrogen constitutes approximately 90% of the atmosphere and that Lipochroman™ exhibits the strongest activity against oxygen free radicals, the observed improvements in signs of photoaging and environmental aging at as early as four weeks are consistent with expectations.
Additionally, the regimen’s tyrosinase inhibitors, including lilac stem cells, tetrahexyldecyl ascorbate, and Chromabright™, are all photoprotective. This characteristic likely contributes to the reduction in redness and the evening of skin tone observed as early as four weeks. The inclusion of two marine extracts, brown algae and Undaria, which act as DNA modulators, appears to be responsible for the overall rejuvenation noted by all participants by week 4. This rejuvenation is attributed to the reduction in Progerin, the skin aging protein, as well as significant reductions in lines and even some nasolabial fold depth, which is likely due to the activation of genes responsible for the synthesis of hyaluronic acid, collagen, and elastin.
The study’s participant group included individuals aged 70 and 75, reflecting a shift in the anti-aging consumer demographic to include women in their seventies and beyond. To obtain a more accurate representation of results when products and regimens are used in the marketplace, we advocate for the inclusion of participants beyond the typical upper age limit of 55 or 60 in clinical studies.