A Clinical Trial to Evaluate the Effects of Naila's Collagen Marine Plus Food Supplement on Skin Hydration, Elasticity, Fine Lines and Wrinkles, and Hair and Nail Health
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- Change in Self-Reported Skin Hydration
研究概览
简要总结
This is a single-group, open-label, virtual (decentralized) clinical trial evaluating the effects of Naila's Collagen Marine Plus Food Supplement on skin hydration, elasticity, firmness, fine lines and wrinkles, and hair and nail health over 12 weeks. Forty healthy adults aged 40-60 years with self-reported mature skin showing early signs of aging will take one sachet of the supplement daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12.
Participants will also submit standardized facial and hair photographs at Baseline and Week 12 for evaluation by a board-certified dermatologist. The primary objectives are to assess changes in skin aging parameters and hair health. Secondary objectives include evaluation of nail health, hair shedding and density, participant-reported satisfaction, and product safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults aged 40-60 years at the time of enrollment.
- •Self-reported visible signs of skin aging, including at least one of the following: fine lines, wrinkles, reduced skin firmness or elasticity, or skin dryness.
- •Self-reports hair shedding and a desire to improve hair health.
- •Willing to take one sachet of the study product daily for 12 weeks as directed.
- •Willing to avoid taking any other collagen-containing dietary supplements for the duration of the study.
- •Willing to maintain current diet, skincare routine, sleep patterns, and physical activity levels for the duration of the trial.
- •Willing and able to submit standardized facial and hair photographs at Baseline and Week
- •Has access to a smartphone or digital camera capable of producing photographs.
- •Resides in the United States.
- •Willing to follow the study protocol and complete all required questionnaires.
排除标准
- •Known allergy or sensitivity to fish, marine-derived products, or any of the study product ingredients (marine collagen, hyaluronic acid, ascorbic acid, biotin).
- •Previous diagnosis of a hair loss condition such as alopecia areata, androgenetic alopecia, or telogen effluvium.
- •Currently taking any collagen-containing dietary supplements, or planning to start taking any collagen supplements in the next 12 weeks.
- •Any current uncontrolled chronic medical condition that would prevent the participant from safely completing the study protocol.
- •History of a diagnosed dermatological condition that significantly affects facial skin appearance (e.g., severe eczema, psoriasis, rosacea, or active acne) and could confound assessment of skin aging outcomes.
- •Use of prescription retinoids, injectable dermal fillers, botulinum toxin, chemical peels, laser skin treatments, or other professional aesthetic procedures on the face within 3 months prior to enrollment or planned during the study period.
- •Currently pregnant, breastfeeding, or planning to become pregnant during the study period.
- •Currently participating in another research study or planning to participate in another study during this study's duration.
- •Any condition that, in the judgment of the investigator, would make the participant unsuitable for inclusion in the study.
结局指标
主要结局
Change in Self-Reported Skin Hydration
时间窗: Baseline to Week 12
Mean change from Baseline in self-reported skin hydration assessed via self-reported questionnaire
Change in Self-Reported Skin Elasticity
时间窗: Baseline to Week 12
Mean change from Baseline in self-reported skin elasticity assessed via self-reported questionnaire
Change in Self-Reported Skin Firmness
时间窗: Baseline to Week 12
Mean change from Baseline in self-reported skin firmness assessed via self-reported questionnaire
Change in Self-Reported Fine Lines and Wrinkles
时间窗: Baseline to Week 12
Mean change from Baseline in self-reported appearance of fine lines and wrinkles assessed via self-reported questionnaire
Change in Dermatologist-Graded Fine Line and Wrinkle Severity
时间窗: Baseline to Week 12
Mean change from Baseline in fine line and wrinkle severity assessed by dermatologist review of standardized facial photographs
Change in Dermatologist-Graded Skin Firmness
时间窗: Baseline to Week 12
Mean change from Baseline in skin firmness assessed by dermatologist review of standardized facial photographs
Change in Dermatologist-Graded Overall Skin Quality
时间窗: Baseline to Week 12
Mean change from Baseline in overall skin quality assessed by dermatologist review of standardized facial photographs
Change in Dermatologist-Graded Hair Parameters
时间窗: Baseline to Week 12
Mean change from Baseline in hair health parameters assessed by dermatologist review of standardized hair photographs
次要结局
- Change in Self-Reported Nail Strength(Baseline to Week 12)
- Change in Self-Reported Nail Brittleness(Baseline to Week 12)
- Change in Self-Reported Nail Growth Rate(Baseline to Week 12)
- Change in Self-Reported Overall Nail Appearance(Baseline to Week 12)
- Change in Self-Reported Hair Shedding(Baseline to Week 12)
- Change in Self-Reported Hair Thickness and Density(Baseline to Week 12)
- Participant-Reported Product Satisfaction and Perceived Global Improvement(Week 12)
- Incidence of Adverse Events(Baseline through Week 12)