Efficacy of Topical Niacinamide Riboside on the Signs of Facial Skin Aging
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age30-60
SponsorChromaDex, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Open to all races provided they meet the inclusion and
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Topical niacinamide riboside
Other interventionNiacinamide 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.
Placebo
Other interventionTopical Skin Care Product: Placebo prepared in a a dry nanofiber pillow, applied topically to the face, twice daily for 12 weeks.
Treatment groups
140 Participants
are divided into 4 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: 2.5% NRExperimental treatment 1 intervention
Group C: 5% NRExperimental treatment 1 intervention
Group D: 10% NRExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in skin's biological age
Dermal curette sampling of the skin at baseline and day 84 to evaluate changes in epigenetic markers of skin aging.
Time frame
baseline and day 842
Quantitative change in fine lines and wrinkles
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."
Time frame
baseline and days 28, 56, and 843
Quantitative changes in skin firmness and tightness
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.
Time frame
baseline and days 56 and 84Secondary outcomes
1
Skin hydration
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.
Time frame
baseline and day 282
Moisture retention
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.
Time frame
baseline and day 283
Skin barrier integrity
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.
Time frame
baseline and day 284
Pores
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.
Time frame
baseline and days 28, 56, and 84Other outcomes
1
Participant Reported Outcome: Skin redness
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.
Time frame
baseline and days 14, 28, 42, 56, and 842
Participant Reported Outcome: Irritation post application
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.
Time frame
baseline and days 14, 28, 42, 56, and 843
Skin Imaging
Illustrative high-resolution digital photographs with Colorface (front face, right and left profiles - Standard 60°, cross polarized, parallel polarized and UV lights)
Time frame
baseline and days 28, 56, and 84Sponsors and contacts
Click on the lead sponsor to view all of their trials.
ChromaDex, Inc.
Lead sponsor
IEC France
Collaborator
SGS S.A.
Collaborator
TruDiagnostic
Collaborator
IEC Afrique du Sud
Collaborator
Deciem
Collaborator
Source ClinicalTrials.gov