NCT05813054已完成不适用
Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Anti-aging Efficacy of Dermial®
Bioiberica2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Skin Moisture
研究概览
简要总结
Oral supplement with an HA matrix ingredient composed of HA (60-75%), sulfated GAGs (≥10%), including DS and CS, and collagen (≥ 5%) to evaluate the hydration of the stratum corneum of facial skin in healthy women showing natural signs of age-related aging versus placebo
详细描述
This study includes 60 healthy volunteers in which will be evaluated if the oral supplement with Dermial [composed of HA (60-75%), sulfated GAGs (≥10%), including DS and CS, and collagen (≥ 5%)] is able to obtain differences versus placebo in healthy women showing natural signs of age-related aging versus placebo . It is a single-center, double-blind, randomized, placebo-controlled clinical study with proportion 1:1 between treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy women between 35 and 65 years of age (inclusive), showing signs of physiological facial skin aging.
- •Women willing not to use any firming product, skin lightening, or any other topical or systemic medication known to affect skin aging or dyschromia during the study period.
- •Be informed of the nature of the study and give their IC in writing.
- •Women willing not to become pregnant during the course of the study, using contraceptive methods considered highly effective.
排除标准
- •Women with allergies to the ingredients in the investigational product.
- •Women who have used a dietary or nutricosmetic supplement containing HA, or who have undergone Botox or HA infiltrations, in the last 6 months prior to signing the IC.
- •Women who have undergone:
- •Superficial or medium-deep chemical peels or dermabrasion within the 6 weeks prior to signing the IC or inclusion document.
- •Deep facial chemical peel, non-ablative laser or fractional laser resurfacing in the 12 months prior to signing the IC or inclusion document.
- •Facial plastic surgery or a laser ablative procedure for photoaging in the 12 months prior to signing the IC or inclusion document.
- •Suspected uncontrolled disease, such as diabetes mellitus (DM), arterial hypertension (HT), hyperthyroidism or hypothyroidism, renal failure or liver failure.
- •Women who have received a PRP (Platelet Rich Plasma) injection as a treatment for aesthetic purposes, in the 3 months prior to inclusion by signing the IC.
- •Women who do not wish, for whatever reason, to take the supplements in the study.
- •Known pregnancy or lactation.
- •Presence of inflammatory skin disease such as psoriasis, atopic dermatitis, rosacea, acne or hidradenitis suppurativa.
- •Presence of active malignant pathologies or premalignant skin lesions such as actinic keratoses.
- •Psychiatric disorder that is not managed or any other circumstance or pathology that prevents the participant from understanding and/or complying with the study procedures.
结局指标
主要结局
Skin Moisture
时间窗: Day 0, 12 week
The changes in the hydration of the facial stratum corneum using the Corneometer® CM825 measuring device, range: 0-130 arbitrary units
次要结局
- Skin pH(Day 0, 6 week, 12 week)
- Skin radiance(Day 0, 6 week, 12 week)
- Skin Moisture(Day 0, 6 week, 12 week)
- Skin elasticity(Day 0, 6 week, 12 week)
- Skin friction(Day 0, 6 week, 12 week)
- Facial Wrinkles and Fine lines of Crow's feet(Day 0, 6 week, 12 week)
- Safety assessment(Day 0 to 12 week (anytime))
- Skin Barrier(Day 0, 6 week, 12 week)
- Skin stiffness/deformability(Day 0, 6 week, 12 week)
- Skin hardness(Day 0, 6 week, 12 week)
- Antioxidant capacity of the skin(Day 0, 6 week, 12 week)
- Glogau Photodamage Scale(Day 0, 6 week, 12 week)
- Skin temperature(Day 0, 6 week, 12 week)
- Erythema and skin melanin index(Day 0, 6 week, 12 week)
- Satisfaction assessed(Day 0, 12 week)
研究者
研究点 (2)
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