Fine Lines and Wrinkles, Skin Aging on Face, Skin Care, Skin Care Dermocosmetics
Conditions
Keywords
nicotinamide riboside, niacinamide riboside, nicotinamide adenine dinucleotide, skin aging, skin aging clock, topical, skin care
Brief summary
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.
Interventions
OTHERTopical 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.
OTHERPlacebo
Topical Skin Care Product: Placebo prepared in a a dry nanofiber pillow, applied topically to the face, twice daily for 12 weeks.
Sponsors
ChromaDex, Inc.
IEC France
SGS S.A.
TruDiagnostic
IEC Afrique du Sud
Deciem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in skin's biological age | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin hydration | 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. |
| Moisture retention | 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. |
| Skin barrier integrity | 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. |
| Pores | 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. |
| Texture/smoothness | 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." |
| Skin tone evenness | 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." |
| Skin plumpness | 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." |
| Radiance | 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." |
| Redness | 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." |
| Firmness | 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."" |
| Participant Reported Outcome: Efficacy and acceptability of product | 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. |
| Adverse Event Monitoring | 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. |
Countries
South Africa
Contacts
CONTACTManoj Choudhry
PRINCIPAL_INVESTIGATORManoj Choudhry
IEC Afrique du Sud
Outcome results
None listed