Aesthetic Study: A New Regenerative Skin Care Regimen Containing Human Platelet Extract

Overview

About this study

The purpose of this trial is to evaluate the cosmetic role of novel anti-aging regenerative skin care product, human platelet extract (HPE), on skin rejuvenation. 

Skin aging is a natural part of human aging process caused by intrinsic and extrinsic factors, such as genetics, cellular metabolism, chronic light exposure and other toxins.  Cosmetological care for facial skin aging includes daily skin care, correct sun protection and aesthetic non-invasive procedures. 80 participants over the age of 40 years with moderate photoaging (dyschromic facial skin with fine lines and wrinkles) will be recruited from Mayo Clinic Center for Aesthetic Medicine and Surgery (CAMS) to participate in the study.  Subjects will be instructed to apply topical HPE to their entire face and decolletage twice daily, in the morning and at bedtime, for 12 weeks.  Subjects will also apply topical HPE versus marked-competitor (Skinceuticals CE Ferulic) to the dorsal hands in a non-randomized fashion.  Evaluations will include cosmetic questionnaires, standard photography and VISIA-CR 3D imaging.  Select subjects will also undergo skin biopsies, skin microbiome analysis and long-term evaluation at week 26 and week 52. This industry-sponsored, cosmetic study evaluates the role of topical HPE Skincare on overall skin appearance for aging skin.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adult males and females, ages 40 to 85 years.
  • Persons of childbearing potential must have a negative pregnancy test prior to receiving the study drug 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 drug to confirm negative results. If the urine pregnancy test is positive, the study drug 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 SAEs 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.
  • 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.

Exclusion Criteria: 

  • Pregnant or nursing, or planning on becoming pregnant during the study period.
  • Subjects who have had an antiaging or esthetic treatment prior to the study: Botox or Botox‐like products, peelings, plastic surgery, resurfacing with Laser, IPL, 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.
  • 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 Vitamin A acid or its derivatives within 3 months before the beginning of the study.
  • Treatment with topical corticoids on the experimental area within 16 days before the study.

Eligibility last updated 2/24/22. Questions regarding updates should be directed to the study team contact.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Open for enrollment

Contact information:

Saranya Wyles M.D., Ph.D.

(507) 284-2555

aesthetic.research@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20523297

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