Skin Tolerance Study

An initial phase scientific study of DermaLastyl-β face cream was conducted by Dr. Steven Lamm to assess tolerance, sensitivity and skin compatibility. A total of 28 volunteers, 25 women and 3 men, applied DermaLastyl-β face cream twice per day for 42 days. They were assessed throughout the study for tolerance and compatibility of the formulation. With the exception of one subject experiencing a slight breakout, all subjects tolerated the product well with no observed redness or irritation.

The subjects also performed a self-assessment of the texture, enhanced elasticity, hydrating, moisturizing, glow and greasiness of the cream.

The majority of those participating in the study stated that the use of DermaLastyl-β cream resulted in significant improvement in their skin’s texture and elasticity, a hydrating/moisturizing effect that lasted throughout the day, a glow to the skin upon application, and that the non-greasy composition allowed makeup directly over the cream. (See Figure 1).

Some participants in the study received unsolicited comments: “What are you doing differently for your skin?” Subjects with fair complexions claimed the cream lightened their skin. Most concluded they were experiencing a more youthful appearance.

Dr. Lamm has determined that based on the very positive effects of this initial stage tolerability/sensitivity/compatibility study, DermaLastyl-β deserves a more rigorous scientific evaluation.

Other Studies

In order to demonstrate the effectiveness of the ingredients used in Dermalastyl, both Laboratory (in vitro) and clinical studies with volunteers (in vivo) were carried out. These studies show that the active ingredients in Dermalastyl reduce the appearance of wrinkles, with a reduction of deep wrinkles by 45% within 2 months. Tropoelastin, the unique and proprietary ingredient in Dermalastyl, was shown in studies using human skin to be able to penetrate into the skin and once within the skins matrix, become incoporated to help prevent the onset of new wrinkles.

Synthesis of Matrix Macromolecules

An in vitro study to was carried out to determine the ability of the Oligopeptides used in Dermalastyl to stimulate fibroblasts (the skin cells that make new propteins such as collagen and elastin). This study showed that human fibroblasts incubated in the laboratory for 72 hours with Palmitoyl Oligopeptides-3 were stimulated to synthesize new collagen, fibronectin and hyaluronic acid, all essential components of the skin matrix. Collagen and hyaluronic acid production were stimulated by 40 – 50% when using a 5% peptide concentration.

Stimulation of Gene Expression

A further study was carried out to measure the stimulation of dermal and epidermal genes by the peptides present in DermaLastyl, using a method called DNA-Array with skin cell cultures to measure stimulation. This study showed that DermalLastyl’s active peptides help the skin’s natural regeneration process.

RESULT - The profile of gene activation by the peptides in DermaLastyl-β complement the skin's natural mechanisms for regeneration

Visible and measurable proof of anti-wrinkle efficacy

An in vivo, clinical study was carried out with 2 groups of 23 volunteers aged 39 to 74. These women applied a cream containing the peptides in DermaLastyl to one-half of their face and used a placebo on the other half twice a day for 56 days. Anti-wrinkling and lifting efficacy was assessed by profilometry and photography. The results were compared to the untreated half. Thesed results showed a significant reduction the depth, volume and surface of deep wrinkles – up to a 45% reduction.

Effect on skin elasticity and tone

The same volunteers were also evaluated for the ability of the DermLastyl peptides to improve skin elasticity and tone. Before and after photographs showed a significant improvement in elasticity and tone during the 2 month treatment period.

The peptides used in DermaLastyl display major and significant improvements in elasticity and tone

Elastin Uptake and Incorporation

Although large molecules such as tropoelastin are not readily taken up by skin, studies carried out on human volunteers have shown that elastin can penetrate to the deepest layers of the stratum corneum; the topmost layer of skin. Table 1 shows the results of a study of the distribution of acetate, laurate, and palmitate derivatives of elastin in the stratum corneum. Both the laurate and palmitate esters of elastin are present in layers 6 –14 of the stratum corneum after 1 hour of exposure. (Usher, T. C. US Patent #4,659,740).

Table 1. Uptake of elastin derivatives by human skin

Once the tropoelastin enters the skin, studies of skin cell cultures have revealed that the elastin is incorporated into the matrix surrounding the cells by crosslinking. The results shown in Table 2 establish that cells in culture can incorporate up to 12% of exogenously supplied tropoelastin into the extracellular matrix. Up to 4.6 ug of elastin can be incorporated into a layer of 400 cm² of cells within 24 hours of application. This corresponds to an estimated elastin replenishment rate of 1.7 mg of facial elastin per year, or 7% of the total elastin estimated to be lost in a lifetime.

Table 2. Incorporation of tropoelastin in cultured cells