A randomized, double blind, placebo controlled, four arm clinical study to evaluate the safety and efficacy of Fibre interlaced Liposomal (FIL) Vitamin C in improving skin health in healthy female volunteers
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary outcomes:
研究概览
简要总结
Normal skin contains high concentrations of vitamin C, which supports important and well-known functions, stimulating collagen synthesis and assisting in antioxidant protection against UV- induced photodamage. This knowledge is often used as a rationale for the addition of vitamin C to topical applications. Important and main mechanisms of action and clinical applications of topical vitamin C on the skin also due to its antioxidative, photoprotective, antiaging, and ant pigmentary effects.1 Topical vitamin C has a wide range of clinical applications, from antiaging and ant pigmentary to photoprotective. Clinical studies on the efficacy of different formulations of topical vitamin C in human skin remain limited. The challenge lies with developing a stable formulation and finding the most efficient trans epidermal delivery method for the esterified forms of vitamin C (e.g., ascorbyl palmitate) to maximize the concentration of active vitamin C in the skin. Recent studies have shown that methods such as nanoparticles, multi-layered microemulsions for graded delivery, ultrasound, iontophoresis, laser resurfacing, and microdermabrasion, can help to enhance penetration of vitamin C. Unlike plants and some animals, humans are unable to synthesize vitamin C due to absence of the enzyme L- glucono-gamma lactone oxidase. Despite high doses of oral supplementation, only a small fraction of vitamin C will be biologically available and active in the skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- Female
入选标准
- •Ambulatory female subjects of 35-60 years with a Body Mass Index (BMI) of 18.5 to 24.9 kgm
- •And having dry skin.
- •Subjects considered as healthy by Principal Investigator through medical history and laboratory results during screening.
- •Subjects who are having 3-6 degrees wrinkles in the crow’s-feet area, with global photo damage score between 3 and
- •Subjects who are not taking Vitamin supplements.
- •Fitzpatrick Skin Photo types III to V
- •Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
- •Subjects voluntarily agree to participate, sign written informed consent and comply with study protocol.
- •Subjects willing to not to take food that could effect on skin condition and continue their normal diet during the study period
- •Female subjects of childbearing potential must be using a medically acceptable form of birth control.
- •Female subjects of non-childbearing potential must be amenorrhoeic for at least 1 year or had a hysterectomy and or bilateral oophorectomy.
排除标准
- •Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded.
- •Individuals with sensitive or hypersensitive skin.
- •Psoriasis patients taking immunosuppressive drugs, severe atopic dermatitis patients.
- •Subjects with a history of photo allergy or photosensitization for minimal erythema test.
- •Expectation of any surgery during the study period.
- •Subject with history of allergies to cosmetics, pharmaceutical products, or foods
- •Use of topical retinoid, any other anti wrinkle steroid products and cosmetic products containing AHA, BHA within the 3 months prior to initiation of the study.
- •Subjects who are using moisture rich cosmetic products within the 2 weeks prior to study initiation.
- •Subjects with uncontrolled Diabetes and Hypertension
- •Subjects with history of renal or liver impairment, any endocrine, inflammatory, cardiovascular, gastro intestinal, neurological, psychiatric, neoplastic or metabolic disease.
- •Subjects with HIV Positive status.
- •Alcohol intake greater than 2 standard drinks per day or use of recreational drugs such as cocaine, methamphetamine, marijuana, etc.
- •and smokers.
- •Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
- •Clinically significant or abnormal laboratory results during screening.
- •Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study period.
结局指标
主要结局
Primary outcomes:
时间窗: Visit2(day 0), Visit 3(Week 1), Visit 4(Week 6), Visit 5(week 12)
Change from baseline to the end of the study period in:
时间窗: Visit2(day 0), Visit 3(Week 1), Visit 4(Week 6), Visit 5(week 12)
1. Skin elasticity by Cutometer.
时间窗: Visit2(day 0), Visit 3(Week 1), Visit 4(Week 6), Visit 5(week 12)
3. Skin hydration by Corneometer.
时间窗: Visit2(day 0), Visit 3(Week 1), Visit 4(Week 6), Visit 5(week 12)
5. Erythema index (EI) and melanin index (MI) by Mexameter.
时间窗: Visit2(day 0), Visit 3(Week 1), Visit 4(Week 6), Visit 5(week 12)
2. Skin collagen measurement by Ultrasound.
时间窗: Visit2(day 0), Visit 3(Week 1), Visit 4(Week 6), Visit 5(week 12)
4. Trans epidermal water loss (TEWL) by Tewameter.
时间窗: Visit2(day 0), Visit 3(Week 1), Visit 4(Week 6), Visit 5(week 12)
次要结局
- Secondary Outcomes:(Change from baseline to the end of the study period in:)