Trial Outcomes & Findings for Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE) (NCT NCT05457491)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

56 participants

Primary outcome timeframe

baseline, 6 weeks

Results posted on

2024-10-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	56
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Human Platelet Extract (HPE) n=56 Participants 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.
Age, Continuous	54 years STANDARD_DEVIATION 11 • n=56 Participants
Sex: Female, Male Female	48 Participants n=56 Participants
Sex: Female, Male Male	8 Participants n=56 Participants
Region of Enrollment United States	56 participants n=56 Participants

PRIMARY outcome

Timeframe: baseline, 6 weeks

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.

Outcome measures

Outcome measures
Measure	Human Platelet Extract (HPE) n=55 Participants 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.
Change in Redness Area	42 percentage of participants

PRIMARY outcome

Timeframe: baseline, 6 weeks

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.

Outcome measures

Outcome measures
Measure	Human Platelet Extract (HPE) n=55 Participants 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.
Change Brown Spot Area Baseline	0.097 pixels Standard Deviation 0.030
Change Brown Spot Area 6 weeks	0.093 pixels Standard Deviation 0.031

PRIMARY outcome

Timeframe: baseline, 6 weeks

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.

Outcome measures

Outcome measures
Measure	Human Platelet Extract (HPE) n=55 Participants 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.
Change in Luminosity Baseline	60.29 pixels Standard Deviation 5.49
Change in Luminosity 6 weeks	63.19 pixels Standard Deviation 5.24

PRIMARY outcome

Timeframe: baseline, 6 weeks

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.

Outcome measures

Outcome measures
Measure	Human Platelet Extract (HPE) n=55 Participants 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.
Change in Color Evenness Baseline	0.51 pixels Standard Deviation 0.07
Change in Color Evenness 6 weeks	0.54 pixels Standard Deviation 0.07

PRIMARY outcome

Timeframe: baseline, 6 weeks

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

Outcome measures

Outcome measures
Measure	Human Platelet Extract (HPE) n=55 Participants 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.
Change in Wrinkles Area Baseline	0.08 pixels Standard Deviation 0.03
Change in Wrinkles Area 6 weeks	0.09 pixels Standard Deviation 0.03

SECONDARY outcome

Timeframe: 12 weeks

Population: Terminated study. Data was not collected nor analyzed

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Data was not collected nor analyzed

Number of subjects to self report satisfied or very satisfied with the treatment on the Modified Cosmetic Improvement questionnaire.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 weeks

Population: Terminated study. Data was not collected nor analyzed

Number of subjects to self report they would recommend the treatment to a friend on the Modified Cosmetic Improvement questionnaire.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: One subject did not complete the questionnaire

The number of subjects to self report they are very likely to continue treatment on the Modified Cosmetic Improvement questionnaire.

Outcome measures

Outcome measures
Measure	Human Platelet Extract (HPE) n=55 Participants 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.
Likelihood of Continuing Topical Cosmetic Treatment	54 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Terminated study. Data was not collected nor analyzed

Number of subjects to self report how the cosmetic treatment affected self-esteem positively or negatively on the Modified Cosmetic Improvement questionnaire.

Outcome measures

Outcome data not reported

Adverse Events

Human Platelet Extract (HPE)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Human Platelet Extract (HPE) n=56 participants at risk 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.
Skin and subcutaneous tissue disorders Dry Skin	16.1% 9/56 • Adverse Events were collected for all subjects from baseline to end of study, approximately 12 weeks

Additional Information

Saranya P. Wyles, M.D., Ph.D.

Mayo Clinic

Phone: 507-284-5475

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place