CTRI/2026/02/102872招募中2 期
A Randomized, Double-Blind, Placebo-Controlled Study to assess the efficacy of EMC-CAP-2025A on Age-related skin parameters in Healthy Individuals
Circul’Egg1 个研究点 分布在 1 个国家入组 60 人开始时间: 2026年3月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the effect of Investigational product at Day 60 in comparison to baseline
研究概览
简要总结
The skin, as the largest organ in the human body, plays essential roles in protecting against environmental insults and preventing moisture loss. Aging is an unavoidable biological process that affects all organs, but it becomes particularly noticeable in the skin due to its visibility and exposure to environmental factors10,11. Skin aging results from both intrinsic and extrinsic factors. Intrinsic aging, a natural and inevitable process driven by genetics and internal metabolic activities, manifests gradually as loss of elasticity, fine lines, and changes in texture. Extrinsic aging, on the other hand, arises from environmental influences such as UV radiation, pollution, stress, and lifestyle factors10,12.
Although animal studies have shown promising outcomes, human research on ESM has largely been limited to evaluating its effects on hair, nails, and basic skin hydration. Comprehensive assessments of its influence across multiple skin parameters remain scarce13. To address this gap, the present study examines the safety and efficacy of product in a randomized, double-blind, placebo-controlled clinical trial. The trial will evaluate diverse markers of skin health—including wrinkling, skin elasticity and firmness, skin hydration, skin texture and roughness, blemishes, hyperpigmentation and skin quality.
研究设计
- 研究类型
- 干预性
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator 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
- Individuals who are willing to understand and sign a written informed consent form prior to the study.
- Healthy male and female individuals aged between 30 to 55 years (both values included).
- Individuals showing symptoms of aging, with mild to moderate wrinkles in crow’s feet area based on PI discretion.
- Individuals with any one of the following skin conditions along with mild to moderate wrinkles: a.
- Under-eye dark circles b.Hyperpigmentation spots (blemish) (post-inflammatory hyperpigmentation, acne marks, age spots, sunspots) c.
- Dry dull skin 5.
- Individuals willing to maintain stable dietary patterns and maintain adequate hydration every day throughout the study 6.
- Individuals who are willing to attend all scheduled study visits at the test center and agree to refrain from applying any topical products (e.g., moisturizers, creams, or similar treatments) 24 hours prior to each visit.
排除标准
- Individuals having an allergy to any of the components of the IP.
- Use of another investigational product within 90 days prior to the screening visit.
- Individuals with any dermatologic disorders or skin conditions that could interfere with the evaluation of proprietary supplement’s effects.
- Individuals having an underlying disease or surgical or medical condition that could put them at risk in the opinion of Principal Investigator, including any uncontrolled chronic or serious disease that would prevent participation in the study, such as cancer, AIDS, diabetes, obesity, renal impairment, psychiatric disorder, compromised immunity, etc.
- Individuals having a history of self-reported allergies to cosmetic and/or sunscreen products.
- Individuals who have used or are unwilling to abstain from using any topical or systemic skin-treatment products or dietary supplements with claims to improve skin hydration, firmness, anti-aging, anti-wrinkle, skin lightening, or dyschromia correction — including those containing alpha/beta/poly-hydroxy acids, salicylic acid, vitamin C, collagen, hyaluronic acid, soy, CoQ-10, chondroitin sulfate, hydroquinone, corticosteroids, tretinoin, retinoids, or any combination thereof — within 1 month prior to screening or during the study period.
- Individuals currently using oral or topical health foods, supplements, pharmaceuticals, or cosmetics that claim whitening or skin-texture improvement effects such as but not limited to glutathione, cysteine, placenta-based extracts, Vitamins C/E/A (retinol), astaxanthin, lycopene, etc., and who cannot refrain from using them during the study period.
- Individuals who have undergone any facial cosmetic or aesthetic procedures, including beauty injections, deep or superficial-to-mid chemical peels, dermabrasion, laser resurfacing, Thermage, tanning, cosmetic surgery, or any equivalent high-energy or anti-aging facial treatments, within 3 months prior to the screening visit.
- Individuals who had hormone replacement therapy within 3 months preceding the screening visit.
- Individuals who have used oral contraceptives or had changed contraceptive method within 3 months prior to the screening visit, or plan to modify contraception treatment within the duration of study.
- Employees of the clinical labs or other testing firms or laboratories, as well as those of cosmetic or raw-material manufacturers of topical products or their suppliers.
- Individuals who are undergoing medical treatment or have a medical history of lupus, scleroderma, atopic dermatitis, acne, facial scarring, psoriasis, eczema, and other autoimmune/inflammatory scaly skin disorders.
- History of uncontrolled hypertension with systolic blood pressure more than or equal to 140 mmHg and/or diastolic blood pressure more than or equal to 90 mmHg. 14.
- Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
- History of smoking or currently smoking and also using any form of smokeless tobacco.
结局指标
主要结局
To assess the effect of Investigational product at Day 60 in comparison to baseline
时间窗: Day 0 to Day 60
次要结局
- To assess the effect of Investigational product at Day 30 in comparison to baseline and placebo on Wrinkles in the nasolabial and lateral canthal region near the eyes as assessed by 3D imaging.(Day 0 to Day 60)
- Skin hydration at Day 30 and Day 60 in comparison to baseline and placebo as assessed by the Moisture Meter SC.(Day 0, Day 30 and Day 60)
- Skin firmness and elasticity at Day 30 and Day 60 in comparison to baseline and placebo as assessed by Cutometer.(Day 0, Day 30 and Day 60)
- Hyperpigmentation spots (blemishes, post-inflammatory hyperpigmentation, acne marks, age spots, sunspots), average pore volume, porosity index, and roughness at Day 30 and Day 60 in comparison to baseline and placebo as assessed by 3D imaging.(Day 0, Day 30 and Day 60)
- Skin texture and roughness at Day 30 and Day 60 in comparison to baseline and placebo as assessed by the Allergan skin roughness scale(Day 0, Day 30 and Day 60)
- Skin quality like lines and wrinkles, crow’s feet, smoothness, skin hydration, moisture, skin tone, skin radiance, skin discomfort such as itching, burning, prickling, irritation, and redness and pimples on skin at Day 30 and Day 60 in comparison to baseline and placebo as assessed by participants self-assessment.(Day 0, Day 30 and Day 60)
- Tolerability of the Investigational Product as assessed by self-assessment questionnaire.(Day 60)
研究者
研究点 (1)
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标识符
- CTRI 编号
- CTRI/2026/02/102872
- 其他研究编号
- CL/142/1125/STU; 250902/IP/AA Version 1 Date 29 Dec 2025
日期
- 最近更新
- (7个月前)
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