Clinical trial NCT05457491: Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE)
Official title: Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Skin Aging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Change in Redness Area
timeFrame: baseline, 6 weeks
measure: Change Brown Spot Area
timeFrame: baseline, 6 weeks
measure: Change in Luminosity
timeFrame: baseline, 6 weeks
measure: Change in Color Evenness
timeFrame: baseline, 6 weeks
measure: Change in Wrinkles Area
timeFrame: baseline, 6 weeks
Secondary outcomes:
measure: Cosmetic Skin Improvement
timeFrame: 12 weeks
measure: Satisfaction With Topical Cosmetic Treatment
timeFrame: 12 weeks
measure: Recommendation of Topical Cosmetic Treatment
timeFrame: 12 weeks
measure: Likelihood of Continuing Topical Cosmetic Treatment
timeFrame: 6 weeks
measure: Topical Cosmetic Treatment on Self-esteem
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Saranya P Wyles, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: