Prior to this clinical study, the longevity scientists at OneSkin had collected highly compelling data on the rejuvenation effects of the OS-01 peptide and the complete OS-01 FACE Topical Supplement formulation by analyzing its effects on skin models grown in the lab from donor cells. While the results of this data were remarkable, they were also limited in that (1) the skin models were in vitro, meaning they were essentially small pieces of skin grown in the lab and not part of an entire organism, and (2) the skin models could only be cultured for 14 days, limiting long-term efficacy studies.

As such, this 12-week clinical study was performed to validate the OS-01 peptide’s effects on skin in living subjects and to test the complete formulation of the OS-01 FACE Topical Supplement for its long-term effects. We are excited to report that the results of this study confirmed the benefits we observed in the lab, further validating the OS-01 FACE Topical Supplement as a truly rejuvenating skin health product.

The key objective of this study was to investigate whether the health parameters induced by treatment with the OS-01 peptide in a laboratory setting [2] would translate to functional and visual benefits in the skin of human subjects.

In the scientific community, clinical studies are regarded as the gold standard to validate the efficacy and safety of new interventions and therapies in human participants. To be considered a validated clinical study, the protocol must adhere to a specific set of standard practices in order to ensure the methodology and results are reliable and accurate. Two core practices include:

1. Prior to execution, the study must be analyzed and approved by an Independent Review Board (IRB), to ensure the methodology of the study is safe and will produce reliable results.
2. When studies are being conducted on behalf of a direct-to-consumer product or brand, it’s common to outsource the execution of the clinical trial to an independent third-party Clinical Research Organization (CRO) – an unbiased research organization that specializes in designing and conducting trials to ensure objective methodology and analysis.

OneSkin’s 12-week clinical study adhered to all standard practices, including the use of a third-party CRO.

The study spanned 12 weeks, with testing performed on live human participants.

• The group of participants was composed of 22 females aged between 47 and 65 years with dry, normal, and combination skin types.
• Application: Participants applied each formula, outlined below, twice daily over 12 weeks.
  • Left side: The participants were instructed to apply the OS-01 FACE Topical Supplement (formula containing the OS-01 peptide and all supporting ingredients) on the left side of their face.
  • Right side: The participants were also instructed to apply a formula containing all ingredients in the OS-01 FACE Topical Supplement except the OS-01 peptide on the right side of their face. This was done to evaluate which effects were the result of including the OS-01 peptide versus which effects could be attributed to the supporting ingredients alone.

Figure 1. Clinical study design.

At various time points throughout the study, the skin on each side of the participants’ faces were independently analyzed in the following three ways:

• Instrumental evaluation:
  • Skin hydration: Measured with a corneometer, a skin hydration instrument.
  • Skin barrier function: Measured using a vapometer that detects trans-epidermal and trans-epithelial water loss.
  • Skin appearance: Measured using the VISIA CR and ANTERA 3D systems which are imaging systems that analyze the topology of the skin.
• Blinded clinical-grade evaluation: Experts unaware of the type of formulation used (blinded experts) evaluated the participants’ skin for fine lines/wrinkles, skin tone/evenness of the skin, pores, skin texture/smoothness, firmness, elasticity, radiance/luminosity, and overall appearance.
• Self-reporting: Participants also completed a self-response questionnaire to record the results they personally observed.

The study compared all skin analysis parameters listed above at baseline (0 weeks) and at the end of the 12-week treatment. Here is a summary of what the study concluded based on the respective results:

It’s important to note that the study commenced at the beginning of the winter season, so a loss of skin hydration over the 12-week testing period was expected due to the seasonal climate changes [1].

• A significant decrease in skin hydration was indeed observed in the skin treated with the formula not containing the OS-01 peptide. As mentioned, this is likely due to the different weather conditions between week 0 and week 12 of the study.
• Interestingly, the skin treated with the formula containing the OS-01 peptide, maintained skin hydration throughout the study period, indicating that the presence of the OS-01 peptide in the formula led to an improvement in skin hydration over 12 weeks.

The skin barrier function was measured via Transepidermal Water Loss (TEWL). TEWL is the amount of water that passively evaporates through skin to the external environment and is used to characterize skin barrier function. The lower the TEWL measurement (less water loss), the stronger the skin barrier function, and vice versa.

• The skin treated with the formulation that did not contain the OS-01 peptide presented no change in TEWL throughout the 12 weeks of the study, meaning that the barrier function did not change as a result of exposing skin to the supporting ingredients in the OS-01 FACE Topical Supplement.
• In contrast, the skin treated with the formulation that did contain the OS-01 peptide presented a 15% lower TEWL measurement compared to baseline. This means that the skin exposed to the formulation containing the OS-01 peptide lost less water over the 12-week testing period, suggesting that the skin barrier functioned better and retained more moisture because of the OS-01 peptide.

Together, this means that the OS-01 peptide not only prevented skin dehydration caused by the winter season, but it actually led to an improvement in water retention in skin due to improved barrier function.

This data is in direct agreement with the lab-based findings at OneSkin, which observed that epidermal thickness increased by more than 20% upon exposure to the OS-01 peptide [2] – a parameter that directly lends to barrier function and skin’s ability to retain hydration.

First it’s important to establish that scientists have proven that skin elasticity reliably decreases with age. This phenomenon is thought to be a main contributor to skin sagging and wrinkling [3][4].

• The blinded experts detected an improvement in skin firmness in 95.5% of the skin treated with the formulation containing the OS-01 peptide.
• Additionally, by touch, the blinded experts were able to detect an improvement in elasticity in 90.9% of skin treated with the formula containing the OS-01 peptide.
• Finally, the participants themselves also observed this change, with 84% of the participants reporting improvements in skin firmness and elasticity on their subjective questionnaires.

To gain context into these visual effects, we included representative images of participants between baseline (0 weeks) and 12 weeks below. By comparing the images in Figure 2 and Figure 3, you can see that the skin is visibly healthier and smoother after 12 weeks of treatment, likely due to the OS-01 peptide’s effects on skin elasticity, hydration, and barrier function.

Figure 2. Skin wrinkle improvement after 12 weeks of OS-01 FACE Topical Supplement. Left: baseline; Right: 12 weeks of treatment.

Figure 3. Skin texture improvement after 12 weeks of OS-01 FACE Topical Supplement. Left: baseline; Right: 12 weeks of treatment.

• Using the VISIA imaging system, skin radiance was shown to improve in 72.7% of participants regardless of which formulation was used, indicating that the supporting ingredients in formula of the OS-01 FACE Topical Supplement are adequate at improving skin radiance without the help of the OS-01 peptide.
• Remarkably, skin evenness was also improved in 95.5% of participants. You can see this in Figure 4.

Figure 4. Skin radiance improvement after 12 weeks of OS-01 FACE Topical Supplement. Left: baseline; Right: 12 weeks of treatment.

Finally, the blinded clinical evaluators concluded that the overall appearance and smoothness of the skin of ALL participants improved regardless of which formulation was applied, indicating that the supporting ingredients alone were effective at improving overall appearance. The formula containing the OS-01 peptide did, however, lead to improved health parameters of the skin on the whole, making the complete OS-01 FACE Topical Supplement formula the best comprehensive approach to improve skin health and appearance.

The graph below summarizes the results experienced from the formula containing the OS-01 peptide and therefore represents the results we expect our customers to experience with 12 weeks of consistent use of the OS-01 FACE Topical Supplement.

Figure 5. Summary of 12-week clinical study results from use of the OS-01 FACE Topical Supplement 2x daily for 12 weeks.

Skin aging is most often visually perceived by the observation of symptoms like fine lines, wrinkles, sagging, and more. These visible signs of aging shouldn’t just be brushed off as inevitable aesthetic declines, but reliable indicators of the underlying molecular alterations in the skin’s tissue. In fact, scientists have been able to determine that below wrinkles, there lie processes of tissue dysfunction which may impact health in general [5]. This is why it is important to dedicate attention and care to the health of the skin.

Moreover, a weak skin barrier is associated with conditions such as eczema and atopic dermatitis and makes the skin more susceptible to pathogen infections, inflammation, and environmental stressors [6][7][8]. Therefore, maintaining a strong skin barrier is one of the most effective strategies to maintain skin homeostasis and optimal function.

The positive data obtained in this study across several parameters (most notably on skin barrier) indicate that the OS-01 peptide improves health markers in the skin of human subjects, and in combination with the supporting ingredients in the OS-01 FACE Topical Supplement, significantly improves visual and functional health markers in skin. With sustainability in mind, OS-01 FACE Topical Supplement is also now available as a refillable face moisturizer.

This study also confirms many of the effects of the OS-01 peptide that OneSkin's scientists have observed in the lab, further validating OneSkin’s lab-based R&D platform.

References

• [1] https://www.karger.com/article/Abstract/47989
• [2] https://www.biorxiv.org/content/10.1101/2020.10.30.362822v2.full
• [3] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6615427/
• [4] https://doi.org/10.1007/978-3-642-27814-3_116-1
• [5] https://doi.org/10.1016/j.jid.2017.01.007\
• [6] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5911439/
• [7] https://nationaleczema.org/what-is-my-skin-barrier/
• [8] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7215310/