Skin AgingPhase 1NCT05457491
Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE)
A Phase 1 study testing Human platelet extract (cosmetic product), Vanicream Gentle Facial Cleanser and EltaMD UV Daily Broad-Spectrum SPF 40 in people with Skin Aging, run by Mayo Clinic at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Skin Aging
- What is being tested?
- Human platelet extract (cosmetic product), Vanicream Gentle Facial Cleanser and EltaMD UV Daily Broad-Spectrum SPF 40
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 7 Jul 2022
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persons of childbearing potential must have a negative pregnancy test prior to receiving the study product and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 2 years until discontinuation of treatment. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study product to confirm negative results. If the urine pregnancy test is positive, the study product will not be administered, and the result will be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed by qualified personnel using kit. Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any Serious Adverse Events (SAE) associated with pregnancy will be recorded.
- All skin phototypes ≥ grade I of Fitzpatrick's classification.
- Mild-to-moderate global face wrinkles and mild-to-moderate global fine lines based on a modified Griffiths' 10-point scale [3].
- Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits and assessments.
- Volunteer willingness to discontinue any other anti-aging topical or parenteral treatments for the duration of the study.
- Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related treatment.
- Can provide written informed consent to being photographed for purposes of treatment for medical, scientific purposes.
Who cannot join
- Pregnant or nursing, or planning on becoming pregnant during the study period
- Subjects who have had an antiaging or aesthetic treatment prior to the study: Botox or Botox-like products, peelings, plastic surgery, resurfacing with Laser, Intense pulsed light (IPL) therapy, threats, radiofrequency treatments, hyaluronic acid treatment, Plasma-Rich Platelets treatment, or any other specific treatments prone to change the skin aspect during the last 6 months
- Individuals with a history of any dermatological disease or condition, including but not limited to active atopic dermatitis, psoriasis, eczema, active seasonal allergies, collagen diseases, or skin cancer involving the treated sites within the past 6 months
- Cutaneous marks on the experimental area which could interfere with the assessment of skin reactions (pigmentation problems, scar elements, over-developed pilosity, ephelides, and nevi in too great quantity, sunburn, beauty spots, freckles, etc.)
- Participants with asymmetric photodamage on dorsal hands due to environmental exposures (i.e., golfing) and/or other skin lesions including burns or scars resulting in significant skin surface variability between dorsal hands
- Eczematous reaction still visible, scar, or pigmentary sequelae of previous tests on the experimental area
Show all 20Show fewer
- Allergy to colophony or nickel.
- Allergy or reactivity to drugs, food or cosmetic products previously observed, including perfumes or cologne products.
- Skin hyper-reactivity.
- Forecast of intensive sun, tanning bed use or UV phototherapy during the test period.
- Treatment with prescription-strength Vitamin A acid or its derivatives within 3 months before the beginning of the study.
- Treatment with topical steroids on the experimental area within 16 days before the study.
- Study constraints:
- No application of products on the experimental area (except the suggested ones), particularly any anti-aging cosmetic products except for sunscreen.
- No change in hygiene habits
- No application of any cosmetic moisturizing products on the face or any makeup on face and lips, on the day of study evaluations
- No change in the way of life or in the physical activity
- No change in dietary activities, or any treatment that significantly impacts body weight
- No exfoliating treatment on the experimental areas
- Description of any treatment undertaken during the study and all eventual deviations
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Skin Aging
- Being tested
- Human platelet extract (cosmetic product), Vanicream Gentle Facial Cleanser, EltaMD UV Daily Broad-Spectrum SPF 40, EltaMD PM Therapy Facial Moisturizer, Vanicream Lite Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Vanicream Gentle Facial CleanserOther
A mild cleanser specifically formulated for daily facial use. Applied to face twice daily for 12 weeks
EltaMD UV Daily Broad-Spectrum SPF 40Other
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.
EltaMD PM Therapy Facial MoisturizerOther
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.
Vanicream Lite LotionOther
Lotion to restore and maintain a normal moisture level. Applied to face twice daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline, 6 weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2022
- Study start1 Oct 2021
- Primary completion7 Jul 2022
- Study completion7 Jul 2022
Why it stopped: Principal Investigator discretion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saranya P. Wyles, Mayo Clinic
- Investigators
- Saranya P Wyles, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05457491
- Sponsor's protocol ID
- 21-008529
- Status last verified
- Sep 2024
- First submitted
- 11 Jul 2022
- Last updated
- 4 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE)
- ClinicalTrials.gov ID
- NCT05457491
- Acronym / sponsor ID
- 21-008529
- Conditions
- Skin Aging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator discretion
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 7 Jul 2022 (actual)
- First posted
- 14 Jul 2022 (actual)
- Results
- Posted 4 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human platelet extract (HPE) | Experimental | 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 LotionSubjects 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Persons of childbearing potential must have a negative pregnancy test prior to receiving the study product and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 2 years until discontinuation of treatment. Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years. A urine pregnancy test will be performed prior to the administration of the study product to confirm negative results. If the urine pregnancy test is positive, the study product will not be administered, and the result will be confirmed by a serum pregnancy test. Urine pregnancy tests will be performed by qualified personnel using kit. Persons becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer. Monitoring will include perinatal and neonatal outcome. Any Serious Adverse Events (SAE) associated with pregnancy will be recorded.
- All skin phototypes ≥ grade I of Fitzpatrick's classification.
- Mild-to-moderate global face wrinkles and mild-to-moderate global fine lines based on a modified Griffiths' 10-point scale [3].
- Fully understanding of the requirements of the study and willingness to comply with the treatment plan, including laboratory tests, diagnostic imaging, and follow-up visits and assessments.
- Volunteer willingness to discontinue any other anti-aging topical or parenteral treatments for the duration of the study.
Key exclusion criteria (20 listed)
- Pregnant or nursing, or planning on becoming pregnant during the study period
- Subjects who have had an antiaging or aesthetic treatment prior to the study: Botox or Botox-like products, peelings, plastic surgery, resurfacing with Laser, Intense pulsed light (IPL) therapy, threats, radiofrequency treatments, hyaluronic acid treatment, Plasma-Rich Platelets treatment, or any other specific treatments prone to change the skin aspect during the last 6 months
- Individuals with a history of any dermatological disease or condition, including but not limited to active atopic dermatitis, psoriasis, eczema, active seasonal allergies, collagen diseases, or skin cancer involving the treated sites within the past 6 months
- Cutaneous marks on the experimental area which could interfere with the assessment of skin reactions (pigmentation problems, scar elements, over-developed pilosity, ephelides, and nevi in too great quantity, sunburn, beauty spots, freckles, etc.)
- Participants with asymmetric photodamage on dorsal hands due to environmental exposures (i.e., golfing) and/or other skin lesions including burns or scars resulting in significant skin surface variability between dorsal hands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human platelet extract (cosmetic product)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. | Biological | Human platelet extract (HPE) |
| Vanicream Gentle Facial CleanserA mild cleanser specifically formulated for daily facial use. Applied to face twice daily for 12 weeks | Other | Human platelet extract (HPE) |
| EltaMD UV Daily Broad-Spectrum SPF 40A 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. | Other | Human platelet extract (HPE) |
| EltaMD PM Therapy Facial MoisturizerA 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. | Other | Human platelet extract (HPE) |
| Vanicream Lite LotionLotion to restore and maintain a normal moisture level. Applied to face twice daily for 12 weeks. | Other | Human platelet extract (HPE) |
Primary outcome
Change in Redness Area
Time frame: 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.
Change Brown Spot Area
Time frame: 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.
Change in Luminosity
Time frame: 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.
Change in Color Evenness
Time frame: 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.
Change in Wrinkles Area
Time frame: 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
5 secondary outcomes
Cosmetic Skin Improvement
Time frame: 12 weeks
Satisfaction With Topical Cosmetic Treatment
Time frame: 12 weeks
Recommendation of Topical Cosmetic Treatment
Time frame: 12 weeks
Likelihood of Continuing Topical Cosmetic Treatment
Time frame: 6 weeks
Topical Cosmetic Treatment on Self-esteem
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saranya P Wyles, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human platelet extract (cosmetic product), Vanicream Gentle Facial Cleanser and EltaMD UV Daily Broad-Spectrum SPF 40 in people with Skin Aging, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Redness Area (time frame: baseline, 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.