CTRI/2026/01/100215尚未招募不适用
Effect of Saffron Extract Capsule Supplement on Skin Rejuvenation and Anti-Ageing in Healthy Adult Male and Female Subjects: Randomised, Double-Blind, Two-Group, Prospective, Multi-Centre Exploratory Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- 1. To evaluate the effectiveness of test products by assessing change in facial wrinkles and finelines of Crow’s feet area, skin texture –dryness, roughness, smoothness, pores using Visioscan® VC 20 Plus within and between product groups.
研究概览
简要总结
This is a randomized, double-blind, comparative, two-arm, prospective, interventional, multi-centre clinical study to evaluate the safety, efficacy, and in-use tolerability of test products, standardized saffron extract capsules, on skin rejuvenation and age-defying benefits in healthy adult male and female subjects. A total of 50 male and non-pregnant, non-lactating female subjects aged 30–55 years will be enrolled, with 25 subjects assigned to each product group (Test Product A and B). Approximately 40 subjects in total (20 per group) are expected to complete the study. There will be total of 5 visits during the study.
· Visit 01 (Day 07 days prior to Day 01): Screening, ICD obtained, Medical history, Sleep Diary, Safety laboratory parameters
· Visit: 02 (Day 01, Week 00): Enrolment, Baseline assessments.
· Visit 03 (Day 45, Week 06): Product Phase, Evaluations
· Visit 04 (Day 90, Week 12): Evaluations, Safety laboratory parameters and End of Product Phase
· Visit 05 (Day 120, Week 16): InstrumentEvaluations only and End of Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 30 to 55 years (both inclusive) at the time of consent.
- •Sex: Adult male and female having wrinkles and fine lines at crow feet’s area, facial hyperpigmentation and dark spots such as tan, pimple marks, sunspots, age spots, uneven skin tone on both side of face.
- •Females of childbearing potential should have a self-reported negative urine pregnancy test at the time of screening visit.
- •Subjects should not have used any cosmetic, nutraceutical or therapeutic products for skin ageing in last 1 month.
- •Subjects must be willing to stop using any cosmetics or any medical products for skin ageing for the duration of the study.
- •Subjects are not allowed to participate in any other study until this study is complete.
- •Subjects must be willing and able to follow the study directions and to return for all specified visits with the product.
- •Subjects must agree to record each use of the test products in the subject’s diary card on daily basis.
- •Subjects must agree to record medication use during the study.
排除标准
- •Subjects who are on steroids for last six months and using immunosuppressive, anti-inflammatory, or hormone-modulating medications that may interfere with study outcomes.
- •Subjects who have used any cosmetic, nutraceutical or therapeutic products for skin last one months.
- •Subjects currently using any oral supplement and topical products containing kojic acid, glycolic acid, niacinamide, alpha arbutin, vitamin C, retinoids, peptides, exfoliating acids, or any other skin-lightening, anti-ageing, or depigmenting agents within the past 4 weeks.
- •Subjects with a known history of hypersensitivity, allergic reactions, or intolerance (such as drowsiness, stomach discomfort, nausea, or vomiting).
- •Subjects with other dermatologic diseases whose presence or products could interfere with the assessment of study.
- •Subjects that are pregnant and/or breastfeeding.
- •The subject has a known allergy or sensitivity to product ingredients.
- •Subjects if do not agree to limit sun exposure to affected areas such as face during prolonged sun exposure.
- •The subject has any other skin conditions i.e. cuts, scratches, ring worms, etc.
- •which in the opinion of the Investigator, will interfere with the study results or will create undue risk for the subject.
- •The subject has any of the conditions or factors that the Investigator believes may affect the response of the skin or the interpretation of the test results.
- •The subject is currently taking or has taken any medication, which the Investigator believes may influence the interpretation of the data.
- •Any other condition which could warrant exclusion from the study, as per the dermatologist’s/investigator’s discretion.
结局指标
主要结局
1. To evaluate the effectiveness of test products by assessing change in facial wrinkles and finelines of Crow’s feet area, skin texture –dryness, roughness, smoothness, pores using Visioscan® VC 20 Plus within and between product groups.
时间窗: 1. Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days) | 2. Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)
2. To evaluate the effectiveness of test products by assessing change in skin tone — L, a, b, and ITA using Skin Colorimeter CL 400 within and between product groups.
时间窗: 1. Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days) | 2. Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days)
次要结局
- To evaluate the effectiveness of test products by assessing change in skin elasticity and firmness using Cutometer Dual MPA 580 (R0 and R2) within and and between product groups.(Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days))
- To evaluate the effectiveness of test products by assessing change in skin texture such as skin dryness, redness, fine lines, coarse wrinkles, laxity, roughness and sallowness evaluated through Physician Global Assessment (PGA) using Griffith’s scale by Dermatologist or dermatologist trained evaluator within and between product groups.(Baseline on Day 01 and post usage of test products on Day 45 (±2 Days) and Day 90 (±2 Days))
- To evaluate the effectiveness of test products by assessing change wrinkles evaluated through Dermatological Evaluation using Glogau Scoring Scale within and between product groups.(Baseline on Day 01 and post usage of test products on Day 45 (±2 Days) and Day 90 (±2 Days))
- To evaluate the effectiveness of test products by assessing change in skin pigmentation evaluated through Dermatological Evaluation using Skin Pigmentation Scoring – MASI Scale within and between product groups.(Baseline on Day 01 and post usage of test products on Day 45 (±2 Days) and Day 90 (±2 Days))
- To evaluate the effectiveness of test products by assessing change in skin hydration using Corneometer® CM 825 within and between product groups.(Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days))
- To evaluate the effectiveness of test products by assessing change in skin thickness and density (Skin Ultrasound) using Mindray DC 70 or similar within and between product groups(Baseline on Day 01 and post usage of test products on Day 90 (±2 Days))
- To evaluate the effectiveness of test products by assessing change in change in visual appearance of facial skin using Visioface® RD within and between product groups.(Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days))
- To evaluate the effectiveness of test products by assessing change in Blood Biomarkers - Malondialdehyde, Total Antioxidant Capacity, Glutathione Levels, Procollagen Type-I C-Peptide, Filaggrin, Salivary Cortisol, Lysozyme Levels within and between product groups.(Baseline on Day 01 and post usage of test products on Day 90 (±2 Days))
- To evaluate the effectiveness of test products by assessing change in sleep pattern by mood and sleep diary evaluated using Basic Nordic Sleep Questionnaire and PROMIS Sleep Disturbance and Distress Scale , and between product groups.(From baseline on 07 days from Day 01 and Day 90 for Basic Nordic Sleep Questionnaire and baseline on 07 days from Day 01, Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days) for PROMIS Sleep Disturbance and Distress Scale)
- To evaluate the effectiveness of test products by assessing change in hair thickness and density using CASLite Nova within and between product groups(Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days))
- To evaluate the effectiveness of the test products by assessing change in stress level using WHOQOL-BREF within and between product groups.(baseline on Day 01 and post usage of test products on Day 45 (±2 Days) and Day 90 (±2 Days))
- To evaluate the effectiveness of test products by assessing change in general skin condition - lines/ wrinkles, age spots, elasticity/firmness, smoothness, radiance, tone evaluated using Visual Analogue Scale (VAS) score within and between product groups.(Baseline on Day 01 and post usage of test products on Day 45 (±2 Days), Day 90 (±2 Days) and Day 120 (±2 Days))
- To evaluate the effectiveness of test products by assessing changes in quality of life regarding test product’s effect on daily life activities using Dermatology Life Quality Index (DLQI) within and between product groups.(baseline on Day 01 and post usage of test product on Day 45 (±2 Days), Day 90 (±2 Days), Day 120 (±2 Days))
- To evaluate the safety of the test product by clinical laboratory parameters, including complete blood count (CBC), Biochemistry, Urinalysis.(Baseline on 07 days prior to day 01 to post-product on Day 90 (±2 Days))
- To evaluate the safety of the test product by the monitoring of product emergent systematic evaluation of adverse events.(Post-product on Day 45 and Day 90 (±2 Days).)
- To evaluate the safety of the test product by checking compliance towards the test products – capsule counts and daily diary entries.(Baseline to post-product on Day 45(±2 Days) and Day 90 (±2 Days))
研究者
Dr Apeksha Merja MD Dermatologist
NovoBliss Research Private Limited
研究点 (2)
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