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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
56
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.
Mayo Clinic
Rochester, Minnesota, United States
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
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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.
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