A Prospective, Open-Label, Single-Arm Clinical Study to Evaluate the Efficacy and Safety of VC-KON™ (Vegan Collagen Supplement) on Skin Elasticity, Skin Hydration, Hair Thickness, Nail Strength, and Musculoskeletal Wellness in Healthy Adult.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This is a prospective, open-label, single-arm clinical study designed to evaluate the efficacy and safety of VC-KON™ (a vegan collagen supplement) in healthy adults aged 30–50 years. The study aims to improve skin elasticity, hydration, firmness, and reduce fine lines, while also supporting hair thickness, nail strength, and musculoskeletal wellness. A total of 30 participants will be enrolled, including males and non-pregnant, non-lactating females with mild to moderate signs of photoaging, joint discomfort, hair fall, and brittle nails. Eligible participants must be in good general health, provide informed consent, and agree to avoid collagen supplements, cosmetic procedures, or hair growth treatments during the study. Key exclusion criteria include dermatological disorders, vitamin D deficiency, recent systemic or topical treatments affecting outcomes, pregnancy, breastfeeding, substance abuse, or clinically significant illness. Primary endpoints include changes in Glogau Photoaging Classification, skin elasticity (Cutometer® R2), hair density and thickness (digital phototrichogram), joint pain (VAS), and handgrip strength at Day 60. Secondary endpoints assess hair shedding, sleep quality (LSEQ QOS), dermatological scores (Modified Griffiths Scale), and nail condition (PGA). Safety will be monitored through adverse events and tolerability.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy adult males and non-pregnant, non-lactating females aged 30–50 years at the time of screening.
- •2.Participants in good general health, as determined by medical history and investigator assessment.
- •3.Presence of mild to moderate crow’s feet wrinkles, as assessed by the investigator.
- •4.Presence of mild to moderate joint pain, swelling, stiffness, and reduced range of motion, including individuals with osteoarthritis, based on medical history and current prescription records.
- •5.A Physician’s Global Assessment (PGA) score indicating at least mild skin aging.
- •6.Glogau photoaging classification of Grade II or III at screening.
- •7.Self-reported hair fall and reduced hair growth, with non-pathological thin, dry, or brittle hair.
- •8.Self-reported weak, dry, or brittle nails.
- •9.No cosmetic or aesthetic procedures involving the face, skin, hair, or nails for at least 3 months prior to screening and throughout the study duration.
- •10.Willingness to avoid initiation of any new skincare, haircare, or cosmetic products during the study period.
- •11.Willingness to maintain stable baseline medications and nutritional supplements, with no use of any collagen or collagen-peptide supplements during the study.
- •12.Participants using hormonal contraceptives or hormone replacement therapy must have been on a stable dose for at least 6 weeks prior to screening and agree to continue the same regimen throughout the study.
- •13.Female participants of childbearing potential must agree to use a reliable method of contraception during the study period.
- •14.Willingness to refrain from using medicated or prescription shampoos, hair products containing minoxidil or anti-thinning agents, or any other hair growth treatments during the study.
- •16.Provision of written informed consent prior to initiation of any study-related procedures.
排除标准
- •1.History of allergy, hypersensitivity, or intolerance to any ingredient of the investigational product or placebo.
- •2.Presence of active or dormant dermatological conditions (e.g., psoriasis, eczema, seborrheic dermatitis, acne, or other skin disorders) that may interfere with study assessments, as determined by the investigator.
- •3.Participant with vitamin D deficiency 4.Use of systemic antibiotics, retinoids, or oral corticosteroids within 4 weeks prior to screening, or anticipated requirement during the study period.
- •5.Use of topical or systemic treatments affecting skin, hair, or nail outcomes within 4 weeks prior to screening.
- •6.History of cosmetic, laser, energy-based, or invasive dermatological procedures involving skin or face within 3 months prior to screening.
- •7.History of hair growth treatments or procedures (e.g., hair transplant, laser therapy) within 3 months prior to screening, or planned scalp hair shaving during the study.
- •8.Unwillingness to avoid excessive sun exposure or ultraviolet radiation during the study period.
- •9.Participation in another clinical, cosmetic, nutraceutical, or therapeutic study within 4 weeks prior to screening.
- •10.Pregnant or breastfeeding women, or women planning pregnancy during the study period.
- •11.History of alcohol or substance abuse, as judged by the investigator.
- •12.Participation in or intention to start a weight-loss program or major dietary modification likely to significantly affect body weight during the study.
- •13.Presence of clinically significant acute or chronic illness that may affect skin, hair, nail, joint, or muscle outcomes, or participants safety.
- •14.Any condition which, in the opinion of the investigator or dermatologist, may compromise participant safety, protocol compliance, or interpretation of study results.
研究者
Dr Sejal Shah
Visage Skin Clinic