The Proof is in the Peptide: 12-Week Clinical Study Validates the Effects of OS-01

10 min read

FEB 29, 2024 - BY THE ONESKIN TEAM
February 29,2024
FROM THE ONESKIN LAB; INGREDIENTS

The Proof is in the Peptide: 12-Week Clinical Study Validates the Effects of OS-01

10 min read

FEB 29, 2024 - BY THE ONESKIN TEAM
February 29,2024
FROM THE ONESKIN LAB; INGREDIENTS
We’re on a mission to change the way people think about skin health and longevity. And while that mission always starts with our R&D platform, the most advanced and sophisticated tool to measure the efficacy of age reversal molecules on skin, we know that real life results can sometimes differ from those in the lab.That’s why we chose to validate the effects of OS-01 FACE and the OS-01 peptide on skin in human subjects, leading to our 12-week double-blind, split face clinical study, which has now been published in the Journal of Cosmetic Dermatology.This clinical study confirms the benefits that we have been predicting ever since we discovered OS-01’s unprecedented ability to reduce the senescent burden in skin: Topical application of the OS-01 peptide improves barrier function, protects against dehydration, reduces appearance of wrinkles, and improves skin texture and radiance. (1) Basically, OS-01 turns back the clock on skin’s biological age, thanks to its ability to clear out the damaged, aging cells that cause your skin to look older. (2)
We’re on a mission to change the way people think about skin health and longevity. And while that mission always starts with our R&D platform, the most advanced and sophisticated tool to measure the efficacy of age reversal molecules on skin, we know that real life results can sometimes differ from those in the lab.That’s why we chose to validate the effects of OS-01 FACE and the OS-01 peptide on skin in human subjects, leading to our 12-week double-blind, split face clinical study, which has now been published in the Journal of Cosmetic Dermatology.This clinical study confirms the benefits that we have been predicting ever since we discovered OS-01’s unprecedented ability to reduce the senescent burden in skin: Topical application of the OS-01 peptide improves barrier function, protects against dehydration, reduces appearance of wrinkles, and improves skin texture and radiance. (1) Basically, OS-01 turns back the clock on skin’s biological age, thanks to its ability to clear out the damaged, aging cells that cause your skin to look older. (2)
01

The Hypothesis

Our lab studies on ex vivo human skin samples and in vitro skin cells proved that the OS-01 peptide can reduce senescent burden in skin and improve skin health profiles. (2) And since senescence in skin is significantly associated with facial wrinkles and perceived age (3), we hypothesized that applying the OS-01 peptide on human skin would reduce the visible signs of aging.
01

The Hypothesis

Our lab studies on ex vivo human skin samples and in vitro skin cells proved that the OS-01 peptide can reduce senescent burden in skin and improve skin health profiles. (2) And since senescence in skin is significantly associated with facial wrinkles and perceived age (3), we hypothesized that applying the OS-01 peptide on human skin would reduce the visible signs of aging.
02

The Methods (and Why They’re Unique)

This study stands out for a few reasons. First, it didn’t just look at the effects of OS-01 FACE on skin; it specifically evaluated the effects of the OS-01 peptide on skin. Using a split-face study, participants applied OS-01 FACE to one side of their face and an identical formulation without the peptide (termed the “vehicle” formulation) to the other. With this approach, it would be clear that any improvements between each side were a direct result of the OS-01 peptide.Given that OS-01 FACE is packed with bioactive ingredients that have their own benefits, comparing it against an identical, peptide-free version really put OS-01 in the spotlight. This method isn’t something you see every day in the skin care industry, making our study not only rigorous, but also quite unique.
02

The Methods (and Why They’re Unique)

This study stands out for a few reasons. First, it didn’t just look at the effects of OS-01 FACE on skin; it specifically evaluated the effects of the OS-01 peptide on skin. Using a split-face study, participants applied OS-01 FACE to one side of their face and an identical formulation without the peptide (termed the “vehicle” formulation) to the other. With this approach, it would be clear that any improvements between each side were a direct result of the OS-01 peptide.Given that OS-01 FACE is packed with bioactive ingredients that have their own benefits, comparing it against an identical, peptide-free version really put OS-01 in the spotlight. This method isn’t something you see every day in the skin care industry, making our study not only rigorous, but also quite unique.
Figure 1. Split-face design
In the table below, you’ll notice the only difference is the presence or absence of the OS-01 peptide:
Figure 1. Split-face design
In the table below, you’ll notice the only difference is the presence or absence of the OS-01 peptide:
Another reason this study is unique? Instrumental analyses were used whenever possible, which unlike expert clinical evaluation and self-perception offer completely objective results. Of course, some results can’t be measured and the way people feel about their skin matters too. That’s why we included expert analysis and personal perception results as well. To minimize bias, our study was double-blinded, meaning that neither the researchers nor the participants knew which side of their face received the OS-01 formula, and which got the lookalike without the peptide.
Another reason this study is unique? Instrumental analyses were used whenever possible, which unlike expert clinical evaluation and self-perception offer completely objective results. Of course, some results can’t be measured and the way people feel about their skin matters too. That’s why we included expert analysis and personal perception results as well. To minimize bias, our study was double-blinded, meaning that neither the researchers nor the participants knew which side of their face received the OS-01 formula, and which got the lookalike without the peptide.
03

How the Study was Conducted

The group of subjects included 22 females aged 47 to 65 years with dry, normal, and combination skin types. Each participant applied the formulas, as outlined above, twice daily over 12 weeks to respective sides of their faces. They were also provided a standard face cleanser (Cetaphil Gentle Cleanser) and sunscreen (Neutrogena Oil-Free Moisture SPF 35) to use on both sides of their faces throughout the study. This ensured that any changes were due to the formulas being tested.

The Analysis Methods

At baseline (0 months), 3 months, and 6 months, the skin on each side of the subjects’ faces were independently analyzed in three ways:1. Instrumental evaluation:
  • Barrier function: We used a vapometer to measure how quickly water evaporates from the skin, also known as trans-epidermal water loss (TEWL). A lower TEWL indicates a stronger skin barrier that keeps hydration in better.
  • Wrinkle indentation and skin texture/smoothness: An Antera 3D imaging instrument provided a 3D reconstruction of the skin’s surface, allowing us to measure the depth and texture of lines and wrinkles on the subjects’ skin.
  • Radiance: High-resolution images were captured using VISIA CR in various lighting settings to assess skin’s radiance, then calculated with analysis software.
2. Blinded expert clinical-grade evaluation: Experts, who were blind to which formula was applied where, evaluated the subjects’ skin for:
  • Fine lines/wrinkles
  • Skin tone (color evenness)
  • Texture/smoothness (visual analysis)
  • Firmness (visual analysis)
  • Elasticity (tactile analysis)
  • Skin pores
  • Radiance/luminosity
  • Overall appearance
3. Self-perception questionnaires: Participants also completed a self-response questionnaire to record the results they personally observed.
03

How the Study was Conducted

The group of subjects included 22 females aged 47 to 65 years with dry, normal, and combination skin types. Each participant applied the formulas, as outlined above, twice daily over 12 weeks to respective sides of their faces. They were also provided a standard face cleanser (Cetaphil Gentle Cleanser) and sunscreen (Neutrogena Oil-Free Moisture SPF 35) to use on both sides of their faces throughout the study. This ensured that any changes were due to the formulas being tested.

The Analysis Methods

At baseline (0 months), 3 months, and 6 months, the skin on each side of the subjects’ faces were independently analyzed in three ways:1. Instrumental evaluation:
  • Barrier function: We used a vapometer to measure how quickly water evaporates from the skin, also known as trans-epidermal water loss (TEWL). A lower TEWL indicates a stronger skin barrier that keeps hydration in better.
  • Wrinkle indentation and skin texture/smoothness: An Antera 3D imaging instrument provided a 3D reconstruction of the skin’s surface, allowing us to measure the depth and texture of lines and wrinkles on the subjects’ skin.
  • Radiance: High-resolution images were captured using VISIA CR in various lighting settings to assess skin’s radiance, then calculated with analysis software.
2. Blinded expert clinical-grade evaluation: Experts, who were blind to which formula was applied where, evaluated the subjects’ skin for:
  • Fine lines/wrinkles
  • Skin tone (color evenness)
  • Texture/smoothness (visual analysis)
  • Firmness (visual analysis)
  • Elasticity (tactile analysis)
  • Skin pores
  • Radiance/luminosity
  • Overall appearance
3. Self-perception questionnaires: Participants also completed a self-response questionnaire to record the results they personally observed.
04

The Results

As scientists, we were particularly drawn to the instrumental data as it provided objective measurements. To further validate these findings, we considered the results from our expert clinical evaluations and participant self-perception questionnaire.Below is a summary of the instrumentation results.
04

The Results

As scientists, we were particularly drawn to the instrumental data as it provided objective measurements. To further validate these findings, we considered the results from our expert clinical evaluations and participant self-perception questionnaire.Below is a summary of the instrumentation results.
Adapted from Table 2 (Zonari, et al., Journal of Cosmetic Dermatology, 2024)*Statistically significant
Adapted from Table 2 (Zonari, et al., Journal of Cosmetic Dermatology, 2024)*Statistically significant

Barrier Function

Skin treated with OS-01 FACE presented a significantly lower TEWL (14% at 6 weeks and 18% at 12 weeks) compared to baseline. This indicates a significant increase in the skin’s barrier function. In contrast, skin treated with the vehicle formulation showed minimal change in TEWL compared to baseline. This highlights the direct impact of the OS-01 peptide on skin barrier improvement.It’s worth noting that this study was conducted in a dry climate during the winter months, when skin is typically more dehydrated. (4) While the vehicle formula didn’t impact TEWL according to vapometer readings, 84% of participants reported an improvement in skin hydration after 12 weeks and 100% reporting an improvement after 6 weeks for both formulations, which is likely a result of the product’s supporting ingredients.The improved skin barrier is thought to be the result of the OS-01 peptide’s ability to increase epidermal thickness and stimulate the expression of HAS2, a key biomarker associated with hyaluronic acid synthesis, as we’ve previously observed in ex vivo human skin samples and 3D human skin models. (2) Additionally, the peptide’s capacity to reduce senescent burden in skin and promote cell proliferation, as shown by increasing the expression of cell proliferation biomarker, Ki67, likely contributes to this result. (2)A stronger skin barrier not only improves appearance, it provides better protection against allergies (5), atopic dermatitis (6), and even systemic inflammation (7).

Barrier Function

Skin treated with OS-01 FACE presented a significantly lower TEWL (14% at 6 weeks and 18% at 12 weeks) compared to baseline. This indicates a significant increase in the skin’s barrier function. In contrast, skin treated with the vehicle formulation showed minimal change in TEWL compared to baseline. This highlights the direct impact of the OS-01 peptide on skin barrier improvement.It’s worth noting that this study was conducted in a dry climate during the winter months, when skin is typically more dehydrated. (4) While the vehicle formula didn’t impact TEWL according to vapometer readings, 84% of participants reported an improvement in skin hydration after 12 weeks and 100% reporting an improvement after 6 weeks for both formulations, which is likely a result of the product’s supporting ingredients.The improved skin barrier is thought to be the result of the OS-01 peptide’s ability to increase epidermal thickness and stimulate the expression of HAS2, a key biomarker associated with hyaluronic acid synthesis, as we’ve previously observed in ex vivo human skin samples and 3D human skin models. (2) Additionally, the peptide’s capacity to reduce senescent burden in skin and promote cell proliferation, as shown by increasing the expression of cell proliferation biomarker, Ki67, likely contributes to this result. (2)A stronger skin barrier not only improves appearance, it provides better protection against allergies (5), atopic dermatitis (6), and even systemic inflammation (7).

Wrinkle Indentation and Skin Texture

In just 6 weeks, OS-01 FACE showed a reduction in wrinkle indentation, compared to the vehicle formulation, which was very close to statistically significant. Conversely, the vehicle formulation showed no change after 6 weeks or 12 weeks.Observe the visible results of OS-01 FACE (OS-01 formulation) and the vehicle formulation below.

Wrinkle Indentation and Skin Texture

In just 6 weeks, OS-01 FACE showed a reduction in wrinkle indentation, compared to the vehicle formulation, which was very close to statistically significant. Conversely, the vehicle formulation showed no change after 6 weeks or 12 weeks.Observe the visible results of OS-01 FACE (OS-01 formulation) and the vehicle formulation below.
Figure 2. Representative images highlgihting skin wrinkles in two subjects after 12 weeks of OS-01 FACE or vehicle formulation treatment. (Zonari, et al., Journal of Cosmetic Dermatology, 2024)
After 12 weeks, skin texture showed a significant improvement with OS-01 FACE compared to the baseline — something that wasn’t observed on the side treated with the vehicle formulation. Check out the visible results of OS-01 FACE (OS-01 formulation) and the vehicle formulation below.
Figure 2. Representative images highlgihting skin wrinkles in two subjects after 12 weeks of OS-01 FACE or vehicle formulation treatment. (Zonari, et al., Journal of Cosmetic Dermatology, 2024)
After 12 weeks, skin texture showed a significant improvement with OS-01 FACE compared to the baseline — something that wasn’t observed on the side treated with the vehicle formulation. Check out the visible results of OS-01 FACE (OS-01 formulation) and the vehicle formulation below.
Figure 3. Representative images highlighting skin texture in two subjects after 12 weeks of OS-01 FACE or vehicle formulation treatment. (Zonari, et al., Journal of Cosmetic Dermatology, 2024)
Expert clinical graders confirmed the enhancements in wrinkle and pore appearance, as well as skin texture, noting improvements from both formulations over time. Not only that, 81% of participants noticed that their skin was softer — results that spanned both formulations.
Figure 3. Representative images highlighting skin texture in two subjects after 12 weeks of OS-01 FACE or vehicle formulation treatment. (Zonari, et al., Journal of Cosmetic Dermatology, 2024)
Expert clinical graders confirmed the enhancements in wrinkle and pore appearance, as well as skin texture, noting improvements from both formulations over time. Not only that, 81% of participants noticed that their skin was softer — results that spanned both formulations.

Radiance

OS-01 FACE significantly improved radiance by +16%, while the vehicle formulation showed a non significant improvement. This was confirmed by the expert clinical graders who noted significant improvements in skin radiance, tone, and overall appearance on both sides of the face. Subjects also observed an improvement in their skin’s radiance and overall appearance.See the results in the images below.

Radiance

OS-01 FACE significantly improved radiance by +16%, while the vehicle formulation showed a non significant improvement. This was confirmed by the expert clinical graders who noted significant improvements in skin radiance, tone, and overall appearance on both sides of the face. Subjects also observed an improvement in their skin’s radiance and overall appearance.See the results in the images below.
Figure 4. Representative images higlighting skin radiance in two subjects after 12 weeks of OS-01 FACE or vehicle formulation treattment. (Zonari, et al., Journal of Cosmetic Dermatology, 2024)
Figure 4. Representative images higlighting skin radiance in two subjects after 12 weeks of OS-01 FACE or vehicle formulation treattment. (Zonari, et al., Journal of Cosmetic Dermatology, 2024)
05

Conclusion

While our previous lab studies confirmed the effects of the OS-01 peptide on skin at the cellular and molecular levels by reducing senescence (2), this study takes a giant leap forward by validating its impact beyond the lab. Here’s a recap:
  • Senescent cells cause visible signs of aging by altering cellular function, increasing tissue inflammation, impacting skin pigmentation, and changing the composition of the extracellular matrix which includes collagen and hyaluronic acid (8)
  • Instrumental analysis revealed that the formula with OS-01 significantly improved skin’s barrier function and texture, improved skin radiance, and promoted a progressive reduction in wrinkles compared to the vehicle formulation (the peptide-free version of OS-01 FACE)
  • Both formulations contain beneficial ingredients such as Pracaxi oil, Andiroba oil, Niacinamide, Pau mulato Oleic Extract, Allantoin, and Hyaluronic Acid, which is why both groups noticed an improvement in skin hydration, firmness and elasticity, radiance, texture and general appearance
By demonstrating the effectiveness of the OS-01 peptide in a real world setting, we’re giving our customers the power to influence the health and appearance of their skin as they age.
05

Conclusion

While our previous lab studies confirmed the effects of the OS-01 peptide on skin at the cellular and molecular levels by reducing senescence (2), this study takes a giant leap forward by validating its impact beyond the lab. Here’s a recap:
  • Senescent cells cause visible signs of aging by altering cellular function, increasing tissue inflammation, impacting skin pigmentation, and changing the composition of the extracellular matrix which includes collagen and hyaluronic acid (8)
  • Instrumental analysis revealed that the formula with OS-01 significantly improved skin’s barrier function and texture, improved skin radiance, and promoted a progressive reduction in wrinkles compared to the vehicle formulation (the peptide-free version of OS-01 FACE)
  • Both formulations contain beneficial ingredients such as Pracaxi oil, Andiroba oil, Niacinamide, Pau mulato Oleic Extract, Allantoin, and Hyaluronic Acid, which is why both groups noticed an improvement in skin hydration, firmness and elasticity, radiance, texture and general appearance
By demonstrating the effectiveness of the OS-01 peptide in a real world setting, we’re giving our customers the power to influence the health and appearance of their skin as they age.

Reviewed by Alessandra Zonari, PhD, Chief Scientific Officer (CSO) and Co-Founder of OneSkin

Alessandra earned her Master’s degree in stem cell biology, and her PhD in skin regeneration and tissue engineering at the Federal University of Minas Gerais in Brazil in collaboration with the 3B’s Research Group in Portugal. Alessandra did a second post-doctoral at the University of Coimbra in Portugal. She is a co-inventor of three patents and has published 20 peer-reviewed papers in scientific journals.

Reviewed by Alessandra Zonari, PhD, Chief Scientific Officer (CSO) and Co-Founder of OneSkin

Alessandra earned her Master’s degree in stem cell biology, and her PhD in skin regeneration and tissue engineering at the Federal University of Minas Gerais in Brazil in collaboration with the 3B’s Research Group in Portugal. Alessandra did a second post-doctoral at the University of Coimbra in Portugal. She is a co-inventor of three patents and has published 20 peer-reviewed papers in scientific journals.

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