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Efficacy of Topical Niacinamide Riboside on the Signs of Facial Skin Aging (NR-RADIANCE)

2026年8月19日 更新者：ChromaDex, Inc.

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

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

140

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 南非
    • Western Cape
      • Cape Town、Western Cape、南非、7925
        • 招聘中
        • I.E.C. Afrique du Sud
        • 接触：
        • 首席研究员：
          • Manoj Choudhry

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Open to all races provided they meet the inclusion and exclusion criteria below:
  • 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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：其他
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo
The participants randomized to this group will receive a product that results in 0% of NR per application.
其他：Placebo
Topical Skin Care Product: Placebo prepared in a a dry nanofiber pillow, applied topically to the face, twice daily for 12 weeks.
实验性的：2.5% NR
The participants randomized to this group will receive a product that results in approximately 2.5% of NR per application.
其他：Topical niacinamide riboside
Niacinamide chloride (NR) prepared in a dry nanofiber pillow will be applied to the skin using a standardized gel serum twice daily, for 12 weeks. NR is a precursor to the essential cellular co-enzyme, NAD+, which has been directly associated with the molecular hallmarks of aging.
其他名称：
  • 烟酰胺核苷
  • Niagen NanoCloud
实验性的：5% NR
The participants randomized to this group will receive a product that results in approximately 5% of NR per application.
其他：Topical niacinamide riboside
Niacinamide chloride (NR) prepared in a dry nanofiber pillow will be applied to the skin using a standardized gel serum twice daily, for 12 weeks. NR is a precursor to the essential cellular co-enzyme, NAD+, which has been directly associated with the molecular hallmarks of aging.
其他名称：
  • 烟酰胺核苷
  • Niagen NanoCloud
实验性的：10% NR
The participants randomized to this group will receive a product that results in approximately 10% of NR per application.
其他：Topical niacinamide riboside
Niacinamide chloride (NR) prepared in a dry nanofiber pillow will be applied to the skin using a standardized gel serum twice daily, for 12 weeks. NR is a precursor to the essential cellular co-enzyme, NAD+, which has been directly associated with the molecular hallmarks of aging.
其他名称：
  • 烟酰胺核苷
  • Niagen NanoCloud

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in skin's biological age
大体时间：baseline and day 84
Dermal curette sampling of the skin at baseline and day 84 to evaluate changes in epigenetic markers of skin aging.
baseline and day 84
Quantitative change in fine lines and wrinkles
大体时间：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."
baseline and days 28, 56, and 84
Quantitative changes in skin firmness and tightness
大体时间：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.
baseline and days 56 and 84

次要结果测量

结果测量
措施说明
大体时间
Participant Reported Outcome: Efficacy and acceptability of product
大体时间：baseline and days 14, 28, 42, 56, and 84
Self-assessment questionnaires regarding perceived efficacy and acceptability of product using a Likert response scale. The questionnaires will be provided during clinic visits and at-home assessments.
baseline and days 14, 28, 42, 56, and 84
Adverse Event Monitoring
大体时间：Up to two weeks after study completion
Adverse events will be monitored at all clinical visits. Participants will be asked immediately report any adverse reaction or any unresolved reactions or skin changes that occur during and after the study is over. Participants will document the adverse reaction, including their interpretation of the severity and time to resolution in their diaries. All suspected adverse events experienced by the participants are to be reported to the Investigator within 48 hours of occurrence, regardless of severity and resolution. The Investigator or designee will evaluate all product-related AEs as to their severity and causality, using standardized definitions.
Up to two weeks after study completion
Skin hydration
大体时间：baseline and day 28
Skin hydration as measured by the Corneometer™ and the ewameter™. Measurements of the skin electrical capacitance by a Corneometer assesses the epidermal upper layers water content and quantifies the moisturizing effect of topical products. Measurement of TransEpidermal Water Loss (T.E.W.L. by aTewameter) is a non-invasive method to assess the integrity of the stratum corneum barrier function, by quantifying the water exchanges between the skin and the environment. Damage of the stratum corneum results in an increase in the T.E.W.L., leading to a more pervious skin.
baseline and day 28
Moisture retention
大体时间：baseline and day 28
Moisture retention is measured by a Tewameter™. Measurement of TransEpidermal Water Loss (T.E.W.L. by Tewameter™) is a non-invasive method to assess the integrity of the stratum corneum barrier function, by quantifying the water exchanges between the skin and the environment. Damage of the stratum corneum results in an increase in the T.E.W.L., leading to a more pervious skin. This method enables to assess and compare the protective effect of cosmetic investigational product(s) on the cutaneous barrier, after repeated applications, in the adult subject.
baseline and day 28
Skin barrier integrity
大体时间：baseline and day 28
Skin barrier integrity is measured by Tewameter™. Measurement of TransEpidermal Water Loss (T.E.W.L. by Tewameter™) is a non-invasive method to assess the integrity of the stratum corneum barrier function, by quantifying the water exchanges between the skin and the environment. Damage of the stratum corneum results in an increase in the T.E.W.L., leading to a more pervious skin. This method enables to assess and compare the protective effect of cosmetic investigational product(s) on the cutaneous barrier, after repeated applications, in the adult subject.
baseline and day 28
Pores
大体时间：baseline and days 28, 56, and 84
A clinical evaluation of pore severity will be scored by a trained assessor. Grading will involve the use of a visual digital photographic scale designed by Qima-Newtone and the Institut d'Expertise Clinique (IEC) will assess pores on the cheek, in the area close to the nose wing. A standardized six point grading scale will be used (0-5), with a grade of 5 indicating greater severity.
baseline and days 28, 56, and 84
Texture/smoothness
大体时间：baseline and days 28, 56, and 84
Skin texture homogeneity of the whole face will be scored by trained assessor. The participant will sit in front of the assessor under controlled conditions. A score range of 0-9, based on visual observations, will be determined. A score of 0 indicates "very heterogeneous skin (rough aspect and/or dilated pores), not uniform skin grain," whereas a score of 9 indicates "very homogeneous skin, same skin grain aspect on the concerned area."
baseline and days 28, 56, and 84
Skin tone evenness
大体时间：baseline and days 28, 56, and 84
Clinical evaluation of visible color disorders/color imperfection will be evaluated by a trained assessor with the subject sitting in front of the assessor under controlled conditions. A score of 0 to 9 will be determined (no intermediate scores, such as fractions or decimals) will be allowed. A score of 0 indicates "no color imperfections (diffuse rednesses and/or brown shades and/or pigmented spots...)," whereas a score of 9 indicates "very marked color imperfections (diffuse rednesses and/or brown shades and/or pigmented spots...), very visible."
baseline and days 28, 56, and 84
Skin plumpness
大体时间：baseline and days 28, 56, and 84
Clinical evaluation of skin plumpness will be evaluated by a trained assessor with the subject sitting in front of the assessor under controlled conditions. A score of 0 to 9 will be determined (no intermediate scores, such as fractions or decimals) will be allowed. A score of 0 indicates "not plump skin, lack of matter, fleshless, emaciated," whereas a score of 9 indicates "very plump skin, chubby."
baseline and days 28, 56, and 84
Radiance
大体时间：baseline and days 28, 56, and 84
Clinical evaluation of whole face skin radiance will be evaluated by a trained assessor with the subject sitting in front of the assessor under controlled conditions. A score of 0 to 9 will be determined (no intermediate scores, such as fractions or decimals) will be allowed. A score of 0 indicates "not radiant skin, dull, does not reflect the light, not homogeneous, coarse skin grain and/or unhealthy glow," whereas a score of 9 indicates "very radiant skin, luminous, reflects the light, homogeneous, fine skin grain and/or healthy glow."
baseline and days 28, 56, and 84
Redness
大体时间：baseline and days 28, 56, and 84
Clinical evaluation of redness visibility will be evaluated by a trained assessor with the subject sitting in front of the assessor under controlled conditions. A score of 0 to 9 will be determined (no intermediate scores, such as fractions or decimals) will be allowed. A score of 0 indicates "no redness visible," whereas a score of 9 indicates "lots of redness visible."
baseline and days 28, 56, and 84
Firmness
大体时间：baseline and days 28, 56, and 84
Clinical evaluation of skin firmness in the hollow are of the cheek will be evaluated by a trained assessor with the subject sitting in front of the assessor under controlled conditions. A score of 0 to 9 will be determined (no intermediate scores, such as fractions or decimals) will be allowed. A score of 0 indicates "not firm skin, "flabby,"" whereas a score of 9 indicates "very firm skin, "hard.""
baseline and days 28, 56, and 84

其他结果措施

结果测量
措施说明
大体时间
Skin Imaging
大体时间：baseline and days 28, 56, and 84
Illustrative high-resolution digital photographs with Colorface (front face, right and left profiles - Standard 60°, cross polarized, parallel polarized and UV lights)
baseline and days 28, 56, and 84
Participant Reported Outcome: Skin redness
大体时间：baseline and days 14, 28, 42, 56, and 84
Participants will describe the perceived redness of their skin using a 1 point Likert scale: 1=Strongly Disagree, 2=Disagree, 3=Neither Agree nor Disagree, 4=Agree, 5=Strongly Agree.
baseline and days 14, 28, 42, 56, and 84
Participant Reported Outcome: Irritation post application
大体时间：baseline and days 14, 28, 42, 56, and 84
Participants will complete questionnaires to indicate their level of agreement with statements related to the current condition of their skin and perceived skin irritation. The responses will be provided using a five point Likert scale, where 1=Strongly Disagree, 2=Disagree, 3=Neither Agree nor Disagree, 4=Agree, and 5=Strongly Agree.
baseline and days 14, 28, 42, 56, and 84

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

ChromaDex, Inc.

合作者

TruDiagnostic
SGS S.A.
IEC France
IEC Afrique du Sud
Deciem

调查人员

  • 首席研究员：Manoj Choudhry、IEC Afrique du Sud

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月17日

初级完成 (估计的)

2026年12月4日

研究完成 (估计的)

2027年3月31日

研究注册日期

首次提交

2026年8月16日

首先提交符合 QC 标准的

2026年8月16日

首次发布 (实际的)

2026年8月19日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月19日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • C26-Z083

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Data may be made available upon reasonable request following the publication of the primary study results.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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