Randomized, Placebo-controlled Clinical Study for the Evaluation and the Comparison of the Dose-response Efficacy of 4 Cosmetic Investigational Products (3 Active, 1 Placebo; 1 Tested Investigational Product Per Subject), After Repeated Applications for 12 Weeks, Under Normal Conditions of Use, in Female Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Reduction in skin's biological age
研究概览
简要总结
Niacinamide riboside (topical NR, also known as nicotinamide riboside) is an endogenous compound and a precursor (building block) to the essential cellular co-enzyme, nicotinamide adenine dinucleotide (NAD+). Research published by Maussudi et al. 2012 demonstrated that skin NAD+ levels were negatively correlated with age in both males and females, and aged skin was also correlated to an increase in DNA damage. Therefore, it is proposed that supporting skin NAD+ with precursors such as NR may be a strategy to combat DNA damage that leads to undesirable signs of skin aging, thus supporting skin cell resilience. The use of NR as a dietary supplement has produced effective, efficient, and reproducible increases in NAD+ in humans. However, the role of topically applied NR for skin aging requires further investigation.
Though not measuring NAD+ directly, this study will explore if topically applied NR reduces the signs of skin aging that may result from cellular NAD+ deficiency. It is hypothesized that the addition of NR to a general skin care regimen will result in healthier, more youthful appearing skin over 12 weeks.
The goal of this interventional clinical trial is to identify the most effective, tolerable, and efficient dose of NR for attenuating quantitative and qualitative indicators of facial skin aging in women ages 30-60. The three primary outcome measures are
- Changes in skin biological age,
- Quantitative reduction in fine lines and wrinkles near the eye, and
- Changes in skin firmness and tightening.
Secondary quantitative and qualitative outcomes include
- Changes to pores, texture, redness, skin tone evenness, radiance, plumpness, and firmness on the global face.
- Changes in skin moisture and skin barrier integrity, and
- Participant perception of perceived efficacy, acceptability, and irritation.
Skin imaging will also be employed in the study.
Participants will be randomized into one of four test product groups:
- Placebo
- 2.5% NR,
- 5% NR, or
- 10% NR.
The test product will be provided in a dry nanofiber sachet, and the percentage of NR is an estimate based on the final concentration of the applied material when mixed in serum.
Following facial cleansing with the provided cleanser, study participants will prepare the test product (immediately before application) by dissolving a single sachet in the provided standardized gel serum. Following application, participants will apply the provided moisturizer and UV serum. Product application will occur twice daily for 84 days (12 weeks). In-clinic assessments will be performed at baseline and days 28, 56, and 84. Participants will also complete at home questionnaires on days 14 and 42. Adverse events and responses will be documented in participant diaries and immediately reported to the clinical research team.
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
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Open to all races provided they meet the inclusion and
排除标准
- •Gender: Female
- •Age: 30 to 60 years old
- •Phototype: I to VI
- •Subject presenting with fines lines/ wrinkles as Crow's feet, inclusion grade ≥ 3 and ≤ 6 on a 10-points scale.
- •Subject presenting with one or more visible signs of skin aging on face (example of signs of skin aging: wrinkles and fine lines, lack of firmness, lack of radiance, pigmented spots, dry and rough skin, visible pores, skin sagging).
- •Subject is not currently using NAD+ or another product containing Vitamin B3 (niacin, niacinamide, nicotinamide, nicotinamide riboside, nicotinamide mononucleotide, myristyl nicotinate, etc.) administered topically, orally intravenously, or through any form of injection, as a part of their current routine or 4 weeks before starting study. The only permitted exception is the use of a multivitamin that contains niacin or nicotinamide. If this is the case, the product and dose of niacin or nicotinamide should be documented at screening and continuation of use of the product should be documented at each site visit.
- •Willingness to maintain current lifestyle, wellness and skin care routines (with the exception of the inclusion of the product requirements incorporated into the study protocol).
- •Exclusion Criteria:
- •Subject not providing consent;
- •Subject not complying with protocol requirements;
- •Subject of whom a health condition has changed since the inclusion visit in the I.E.C database, making the subject ineligible or places her at undue risk;
- •Active cancer diagnosis or diagnosis of cancer of any kind less than three years since remission, liver disease, kidney disease, or uncontrolled diabetes;
- •Pregnancy, actively breastfeeding, or not willing to take necessary precautions to avoid a pregnancy during the study;
- •Subject having a medical treatment, recent vaccination or expecting to be vaccinated during the study, that makes the subject ineligible or places her at undue risk, in particular, medical treatment (either oral or topical) containing tretinoin or isotretinoin during the 3 months before the starting day of the study;
- •Subject having a background of intolerance or allergy to cosmetics, NAD+ or any vitamin B3 derivative, ingredients in the auxiliary products or to other substances that makes the subject ineligible or places her at undue risk;
- •Subject having visible traces of irritation or any other abnormality on the concerned area;
- •Subject having skin recently exposed to excessive sunlight (natural or artificial) within 4 weeks preceding the inclusion;
- •Subject having undergone surgery, chemical or physical treatment to the concerned area in the last 12 months (no injection during the last 6 months);
- •Subject having applied anti-wrinkle/anti-aging/firming products on concerned area during the 4 weeks before the starting day of the study;
- •Subject having had any cosmetic procedures performed in the last six months (including Botox, peels, laser, etc.);
- •Subject having applied NAD+/B-vitamin products on the concerned area during the 4 weeks before the starting day of the study;
- •Subject having modified his/her cosmetic habits (on the concerned area by the study) during the last 2 weeks, making her ineligible;
- •Subject having applied cosmetic or pharmaceutical products (other than their usual cleanser) to the areas of concern during the 96 hours before the starting day of the study and on the day of inclusion;
- •Subject having applied any cosmetic or pharmaceutical products (only water allowed) to the areas of concern the day of inclusion.
研究组 & 干预措施
10% NR
The participants randomized to this group will receive a product that results in approximately 10% of NR per application.
干预措施: Topical niacinamide riboside (Other)
Placebo
The participants randomized to this group will receive a product that results in 0% of NR per application.
干预措施: Placebo (Other)
2.5% NR
The participants randomized to this group will receive a product that results in approximately 2.5% of NR per application.
干预措施: Topical niacinamide riboside (Other)
5% NR
The participants randomized to this group will receive a product that results in approximately 5% of NR per application.
干预措施: Topical niacinamide riboside (Other)
结局指标
主要结局
Reduction in skin's biological age
时间窗: baseline and day 84
Dermal curette sampling of the skin at baseline and day 84 to evaluate changes in epigenetic markers of skin aging.
Quantitative change in fine lines and wrinkles
时间窗: baseline and days 28, 56, and 84
The severity of fine lines and wrinkles will be clinically scored by a trained assessor evaluating 1) the Crow's feet area near the eye, and 2) the area underneath the eye, separately. Scoring for each area will range from 0 to 9, and intermediate scores (including fractions and decimals) will not be allowed. A score of 0 will indicate "no wrinkles," whereas a score of 9 will indicate "very marked wrinkles, accounting for number, surface and depth."
Quantitative changes in skin firmness and tightness
时间窗: baseline and days 56 and 84
Changes in skin firmness and tightness will be measured by a Cutometer™ to objectively assess and compare the effect of the product on the skin's biomechanical properties. The device measures the deformation of a cutaneous area, submitted to a mechanical suction and its recovering power (Wilhelm et al., 1993). The skin viscoelastic properties are directly correlated to skin suppleness, elasticity, tonicity and firmness. The measurement will take place in the hollow of the cheek, providing a tactile measurement.
Change in skin's biological age
时间窗: baseline and day 84
Dermal curette sampling of the skin at baseline and day 84 to evaluate changes in epigenetic markers of skin aging.
次要结局
- Participant Reported Outcome: Efficacy and acceptability of product(baseline and days 14, 28, 42, 56, and 84)
- Adverse Event Monitoring(Up to two weeks after study completion)
- Skin hydration(baseline and day 28)
- Moisture retention(baseline and day 28)
- Skin barrier integrity(baseline and day 28)
- Pores(baseline and days 28, 56, and 84)
- Texture/smoothness(baseline and days 28, 56, and 84)
- Skin tone evenness(baseline and days 28, 56, and 84)
- Skin plumpness(baseline and days 28, 56, and 84)
- Radiance(baseline and days 28, 56, and 84)
- Redness(baseline and days 28, 56, and 84)
- Firmness(baseline and days 28, 56, and 84)