A Phase 1 interventional study of Human platelet extract (cosmetic product) and Vanicream Gentle Facial Cleanser in Skin Aging, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by Mayo Clinic · Phase 1, Interventional, and Other
The Researchers are trying to study a cosmetic skin care product called human platelet extract (HPE) to see if it can be used as a possible treatment for skin anti-aging and skin rejuvenation. They are trying find out the safety and tolerability of topical HPE after multiple doses of topical administration
Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Study constraints:
Subjects will follow a standardized twice daily skin care regimen of applying morning and night. Morning skin care routine includes Vanicream Gentle Facial Cleanser, human platelet extract, and EltaMD UV Daily Broad-Spectrum SPF 40, or Vanicream Lite Lotion. Evening skin care routine includes Vanicream Gentle Facial cleanser, human platelet extract, and EltaMD PM Therapy Facial Moisturizer or Vanicream Lite Lotion
Biological: Human platelet extract (cosmetic product) · Other: Vanicream Gentle Facial Cleanser · Other: EltaMD UV Daily Broad-Spectrum SPF 40 · Other: EltaMD PM Therapy Facial Moisturizer · Other: Vanicream Lite Lotion
A leukocyte depleted allogeneic product derived from human U.S. sourced pooled apheresed platelets (derived from screened healthy donors). Applied to face twice daily for 12 weeks.
A mild cleanser specifically formulated for daily facial use. Applied to face twice daily for 12 weeks
A daily moisturizer with a lightweight formula that provides broad-spectrum sunscreen protection. EltaMD UV Daily Broad-Spectrum SPF 40 provides powerful protection against the sun's harmful UV rays, as it hydrates and is gentle enough for post-procedure skin. Powered by hyaluronic acid, this face sunscreen plumps the skin with lightweight moisture, while micronized zinc and octinoxate shield skin from UVA/UVB rays to prevent the visible signs of environmentally caused aging. Applied to face once daily for 12 weeks.
A fortifying face moisturizer to repair elasticity and vitality. EltaMD PM Therapy Facial Moisturizer restores youthfulness while strengthening the skin's natural moisture barrier. Niacinamide blends with antioxidants to boost the skin color and tone, as it speeds up the skin's repair processes. Rice protein peptides aid in encouraging cell growth, promoting collagen formation and improving elasticity. Applied to face once daily for 12 weeks.
Lotion to restore and maintain a normal moisture level. Applied to face twice daily for 12 weeks.
Change in Redness Area
The percentage of participants to experience at least 50% improvement in redness area over baseline. As measured by photodocumentation with the VISIA-CR Generation 5 3D PRIMOS using RBX technology. Redness pixel variation and the cross polarized image were transformed into red images that correlated with hemoglobin absorption/distribution.
Time frame: baseline, 6 weeks
Change Brown Spot Area
Photodocumentation with the VISIA-CR Generation 5 3D PRIMOS to assess overall variation in color values specifically pixel variation across defined cosmetic subunits and how rapidly those colors change spatially within it, producing a score from 0 to 1, where 0 is less melanin or brown color and 1 is more melanin or brown color. Lower scores reflect better outcomes.
Time frame: baseline, 6 weeks
Change in Luminosity
Luminosity (color intensity) is the measure of the light reflected from the skin surface. Photodocumentation with the VISIA-CR Generation 5 3D PRIMOS to assess overall variation in color values specifically pixel variation across defined cosmetic subunits and how rapidly those colors change spatially within it. Lower values reflect dull and/or uneven skin tones. Higher values reflect radiant and/or even-appearing skin tones.
Time frame: baseline, 6 weeks
Change in Color Evenness
Photodocumentation with the VISIA-CR Generation 5 3D PRIMOS to assess overall variation in color values specifically pixel variation across defined cosmetic subunits and how rapidly those colors change spatially within it, producing a score from 0 to 1, where 0 is dull and/or uneven skin tone and 1 is radiant and/or even-appearing skin tone. Higher scores reflect better outcomes.
Time frame: baseline, 6 weeks
Change in Wrinkles Area
Photodocumentation with the VISIA-CR Generation 5 3D PRIMOS to assess forehead wrinkles using 3D fringe projection which evaluates static wrinkles and measures the difference in fractional area change
Time frame: baseline, 6 weeks
Cosmetic Skin Improvement
Change measured by the self reported Global Aesthetic Improvement Assessment where subjects grade/rate their improvement as Exceptional/very much improved, Moderate/much improved, Slight, No change or Worse.
Time frame: 12 weeks
Satisfaction With Topical Cosmetic Treatment
Number of subjects to self report satisfied or very satisfied with the treatment on the Modified Cosmetic Improvement questionnaire.
Time frame: 12 weeks
Recommendation of Topical Cosmetic Treatment
Number of subjects to self report they would recommend the treatment to a friend on the Modified Cosmetic Improvement questionnaire.
Time frame: 12 weeks
Likelihood of Continuing Topical Cosmetic Treatment
The number of subjects to self report they are very likely to continue treatment on the Modified Cosmetic Improvement questionnaire.
Time frame: 6 weeks
Topical Cosmetic Treatment on Self-esteem
Number of subjects to self report how the cosmetic treatment affected self-esteem positively or negatively on the Modified Cosmetic Improvement questionnaire.
Time frame: 12 weeks
| Milestone | Human Platelet Extract (HPE) |
|---|---|
| Started | 56 |
| Completed | 56 |
| Not completed | 0 |
The percentage of participants to experience at least 50% improvement in redness area over baseline. As measured by photodocumentation with the VISIA-CR Generation 5 3D PRIMOS using RBX technology. Redness pixel variation and the cross polarized image were transformed into red images that correlated with hemoglobin absorption/distribution.
| percentage of participants | Human Platelet Extract (HPE) |
|---|---|
| Change in Redness Area | 42 |
Photodocumentation with the VISIA-CR Generation 5 3D PRIMOS to assess overall variation in color values specifically pixel variation across defined cosmetic subunits and how rapidly those colors change spatially within it, producing a score from 0 to 1, where 0 is less melanin or brown color and 1 is more melanin or brown color. Lower scores reflect better outcomes.
| pixels | Human Platelet Extract (HPE) |
|---|---|
| Baseline | 0.097 ± 0.030 |
| 6 weeks | 0.093 ± 0.031 |
Luminosity (color intensity) is the measure of the light reflected from the skin surface. Photodocumentation with the VISIA-CR Generation 5 3D PRIMOS to assess overall variation in color values specifically pixel variation across defined cosmetic subunits and how rapidly those colors change spatially within it. Lower values reflect dull and/or uneven skin tones. Higher values reflect radiant and/or even-appearing skin tones.
| pixels | Human Platelet Extract (HPE) |
|---|---|
| Baseline | 60.29 ± 5.49 |
| 6 weeks | 63.19 ± 5.24 |
Photodocumentation with the VISIA-CR Generation 5 3D PRIMOS to assess overall variation in color values specifically pixel variation across defined cosmetic subunits and how rapidly those colors change spatially within it, producing a score from 0 to 1, where 0 is dull and/or uneven skin tone and 1 is radiant and/or even-appearing skin tone. Higher scores reflect better outcomes.
| pixels | Human Platelet Extract (HPE) |
|---|---|
| Baseline | 0.51 ± 0.07 |
| 6 weeks | 0.54 ± 0.07 |
Photodocumentation with the VISIA-CR Generation 5 3D PRIMOS to assess forehead wrinkles using 3D fringe projection which evaluates static wrinkles and measures the difference in fractional area change
| pixels | Human Platelet Extract (HPE) |
|---|---|
| Baseline | 0.08 ± 0.03 |
| 6 weeks | 0.09 ± 0.03 |
Change measured by the self reported Global Aesthetic Improvement Assessment where subjects grade/rate their improvement as Exceptional/very much improved, Moderate/much improved, Slight, No change or Worse.
No measurements were reported for this outcome.
Number of subjects to self report satisfied or very satisfied with the treatment on the Modified Cosmetic Improvement questionnaire.
No measurements were reported for this outcome.
Number of subjects to self report they would recommend the treatment to a friend on the Modified Cosmetic Improvement questionnaire.
No measurements were reported for this outcome.
The number of subjects to self report they are very likely to continue treatment on the Modified Cosmetic Improvement questionnaire.
| Participants | Human Platelet Extract (HPE) |
|---|---|
| Likelihood of Continuing Topical Cosmetic Treatment | 54 |
Number of subjects to self report how the cosmetic treatment affected self-esteem positively or negatively on the Modified Cosmetic Improvement questionnaire.
No measurements were reported for this outcome.
Collected over Adverse Events were collected for all subjects from baseline to end of study, approximately 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Human Platelet Extract (HPE) | 0/56 (0%) | 0/56 (0%) | 9/56 (16.1%) |
| Event | Human Platelet Extract (HPE) |
|---|---|
| Dry SkinSkin and subcutaneous tissue disorders | 9/56 |
| Age, Continuous(years) | Human Platelet Extract (HPE) |
|---|---|
| Mean | 54 ± 11 |
| Sex: Female, Male(Participants) | Human Platelet Extract (HPE) |
|---|---|
| Female | 48 |
| Male | 8 |
| Race and Ethnicity Not Collected(Participants) | Human Platelet Extract (HPE) |
|---|
| Region of Enrollment(participants) | Human Platelet Extract (HPE) |
|---|---|
| United States | 56 |
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