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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human platelet extract (HPE) | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human platelet extract (cosmetic product) | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Satisfaction With Topical Cosmetic Treatment |
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Inclusion Criteria:
Exclusion Criteria:
Study constraints:
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| Name | Affiliation | Role |
|---|---|---|
| Saranya P Wyles, M.D., Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Human Platelet Extract (HPE) | Subjects followed a standardized twice daily skin care regimen of applying morning and night for 12 weeks. Morning included Vanicream Gentle Facial Cleanser, human platelet extract, and EltaMD UV Daily Broad-Spectrum SPF 40, or Vanicream Lite Lotion. Evening skin care routine included Vanicream Gentle Facial cleanser, human platelet extract, and EltaMD PM Therapy Facial Moisturizer or Vanicream Lite Lotion. Human platelet extract is a leukocyte depleted allogeneic product derived from human U.S. sourced pooled apheresed platelets (derived from screened healthy donors. Vanicream Gentle Facial Cleanser is a mild cleanser specifically formulated for daily facial use. EltaMD UV Daily Broad-Spectrum SPF 40 is a daily moisturizer with a lightweight formula that provides broad-spectrum sunscreen protection. EltaMD PM Therapy Facial Moisturizer is a fortifying face moisturizer to repair elasticity and vitality. Vanicream Lite Lotion is a lotion to restore and maintain a normal moisture level. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 19, 2022 |
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| Vanicream Gentle Facial Cleanser | Other | A mild cleanser specifically formulated for daily facial use. Applied to face twice daily for 12 weeks |
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| EltaMD UV Daily Broad-Spectrum SPF 40 | Other | 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. |
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| EltaMD PM Therapy Facial Moisturizer | Other | 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. |
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| Vanicream Lite Lotion | Other | Lotion to restore and maintain a normal moisture level. Applied to face twice daily for 12 weeks. |
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| baseline, 6 weeks |
Number of subjects to self report satisfied or very satisfied with the treatment on the Modified Cosmetic Improvement questionnaire. |
| 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. | 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. | 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. | 12 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Human Platelet Extract (HPE) | Subjects followed a standardized twice daily skin care regimen of applying morning and night for 12 weeks. Morning included Vanicream Gentle Facial Cleanser, human platelet extract, and EltaMD UV Daily Broad-Spectrum SPF 40, or Vanicream Lite Lotion. Evening skin care routine included Vanicream Gentle Facial cleanser, human platelet extract, and EltaMD PM Therapy Facial Moisturizer or Vanicream Lite Lotion. Human platelet extract is a leukocyte depleted allogeneic product derived from human U.S. sourced pooled apheresed platelets (derived from screened healthy donors. Vanicream Gentle Facial Cleanser is a mild cleanser specifically formulated for daily facial use. EltaMD UV Daily Broad-Spectrum SPF 40 is a daily moisturizer with a lightweight formula that provides broad-spectrum sunscreen protection. EltaMD PM Therapy Facial Moisturizer is a fortifying face moisturizer to repair elasticity and vitality. Vanicream Lite Lotion is a lotion to restore and maintain a normal moisture level. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | percentage of participants | baseline, 6 weeks |
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| Primary | 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. | Posted | Mean | Standard Deviation | pixels | baseline, 6 weeks |
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| Primary | 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. | Posted | Mean | Standard Deviation | pixels | baseline, 6 weeks |
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| Primary | 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. | Posted | Mean | Standard Deviation | pixels | baseline, 6 weeks |
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| Primary | 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 | Posted | Mean | Standard Deviation | pixels | baseline, 6 weeks |
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| Secondary | 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. | Terminated study. Data was not collected nor analyzed | Posted | 12 weeks |
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| Secondary | Satisfaction With Topical Cosmetic Treatment | Number of subjects to self report satisfied or very satisfied with the treatment on the Modified Cosmetic Improvement questionnaire. | Data was not collected nor analyzed | Posted | 12 weeks |
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| Secondary | 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. | Terminated study. Data was not collected nor analyzed | Posted | 12 weeks |
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| Secondary | 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. | One subject did not complete the questionnaire | Posted | Count of Participants | Participants | 6 weeks |
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| Secondary | 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. | Terminated study. Data was not collected nor analyzed | Posted | 12 weeks |
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Adverse Events were collected for all subjects from baseline to end of study, approximately 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Human Platelet Extract (HPE) | Subjects followed a standardized twice daily skin care regimen of applying morning and night for 12 weeks. Morning included Vanicream Gentle Facial Cleanser, human platelet extract, and EltaMD UV Daily Broad-Spectrum SPF 40, or Vanicream Lite Lotion. Evening skin care routine included Vanicream Gentle Facial cleanser, human platelet extract, and EltaMD PM Therapy Facial Moisturizer or Vanicream Lite Lotion. Human platelet extract is a leukocyte depleted allogeneic product derived from human U.S. sourced pooled apheresed platelets (derived from screened healthy donors. Vanicream Gentle Facial Cleanser is a mild cleanser specifically formulated for daily facial use. EltaMD UV Daily Broad-Spectrum SPF 40 is a daily moisturizer with a lightweight formula that provides broad-spectrum sunscreen protection. EltaMD PM Therapy Facial Moisturizer is a fortifying face moisturizer to repair elasticity and vitality. Vanicream Lite Lotion is a lotion to restore and maintain a normal moisture level. | 0 | 56 | 0 | 56 | 9 | 56 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
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Study was terminated early per Principal Investigator
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Saranya P. Wyles, M.D., Ph.D. | Mayo Clinic | 507-284-5475 | Wyles.Saranya@mayo.edu |
| Dec 28, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003358 | Cosmetics |
| ID | Term |
|---|---|
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D006795 | Household Products |
| D013676 | Technology, Industry, and Agriculture |
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