Novel Antiaging Regenerative Skin Care Regimen Containing Human Platelet Extract (HPE)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in Redness Area
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Human platelet extract (HPE)
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
干预措施: Human platelet extract (cosmetic product) (Biological)
Human platelet extract (HPE)
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
干预措施: Vanicream Gentle Facial Cleanser (Other)
Human platelet extract (HPE)
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
干预措施: EltaMD UV Daily Broad-Spectrum SPF 40 (Other)
Human platelet extract (HPE)
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
干预措施: EltaMD PM Therapy Facial Moisturizer (Other)
Human platelet extract (HPE)
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
干预措施: Vanicream Lite Lotion (Other)
结局指标
主要结局
Change in Redness Area
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
次要结局
- Cosmetic Skin Improvement(12 weeks)
- Satisfaction With Topical Cosmetic Treatment(12 weeks)
- Recommendation of Topical Cosmetic Treatment(12 weeks)
- Likelihood of Continuing Topical Cosmetic Treatment(6 weeks)
- Topical Cosmetic Treatment on Self-esteem(12 weeks)
研究者
Saranya P. Wyles
Principal Investigator
Mayo Clinic