NCT07620158已完成不适用
Proof of Concept Split-Face Single-Blind Study to Assess the Cosmetic Appearance of Skin on Subjects Using the Vitro Biopharma Secretome/Exosome Serum
Vitro Biopharma Inc.1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2024年4月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
研究概览
简要总结
The purpose of this research is to characterize the safety, tolerability and efficacy of the investigational topical cosmetic product, the Vitro Biopharma Exosome Serum (Intervention), in impacting the cosmetic appearance of skin along with a microneedling procedure.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects over 30 years of age
- •Non-smoker
- •Fitzpatrick scale II-IV
- •Mild to moderate skin wrinkles or fine lines around the eyes (periorbital) and/or radial cheek
- •Subject agrees to maintain their weight (i.e. within 5%) by not making any major changes in diet of lifestyle during study
- •Able to provide written informed consent, understand and willing to comply with study related procedures and follow-up
- •Willing to undergo facial microneedling treatment
- •Willing to sign photo release (For study purposes and potential publication)
排除标准
- •Prior trauma, surgical procedure or invasive cosmetic procedure in the area of intended treatment
- •Fat reduction/removal procedure in or around the area of intended treatment up to 1 year prior to enrollment
- •Cosmetic injections into the area of intended treatment including botulinum toxin injections up to 6 months prior or filler injections up to 1 year prior to enrollment
- •Ablative or non-ablative dermal resurfacing procedures within 6 months of screening
- •Skin tightening procedures on the face within the past 3 months
- •Currently using prescription facial wrinkle therapies
- •History of bleeding disorder, or is taking any medication that may increase risk of bruising
- •Dermatological conditions in the location of the treatment sites that may interfere with treatment
- •Subject has an active infection
- •Subject has a known metal allergy
- •Pre-existing scars, tattoos, birthmarks or other physical features in the area of treatment that may confound the outcome in the investigators opinion
- •Active implanted device such as pacemaker, defibrillator, drug delivery system
- •Pregnant or intending to become pregnant
- •Lactating or has been lactating in the last 6 months
- •History of coagulopathy, or taking anticoagulants
- •Taking daily oral aspirin
- •Immunocompromised or immunosuppressed
- •Active, chronic or recurrent infection
- •Hypersensitivity to analgesic agents
- •History of keloid scar formation
- •Chronic disease such as diabetes, hepatitis, etc.
- •Oral corticosteroids or topical steroids in the treatment area
- •Prescription or over the counter (OTC) medication or cosmetics applied to treatment area containing: retinoids, glycol acid, salicylic acid or any other remedies that might affect the healing process.
- •Co-morbid condition that could limit ability to participate in the study or comply with follow-up requirements
- •Untreated drug and/or alcohol abuse
- •Unable or unwilling to comply with the study requirements
- •Enrolled in another clinical study or taking any unknown or not Food and Drug Administration (FDA) approved medications
- •Any other condition or presentation that in the opinion of the Investigator might exclude the subject
- •Intends to begin any new skin medications in the treatment areas
- •Intends to change their daily skincare routine before or during the study
研究者
研究点 (1)
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