Efficacy of Topical Niacinamide Riboside on the Signs of Facial Skin Aging

Dermal curette sampling of the skin at baseline and day 84 to evaluate changes in epigenetic markers of skin aging.

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."

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.

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 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 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.

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.

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."

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."

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."

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."

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."

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.""

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 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.

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.

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.

Illustrative high-resolution digital photographs with Colorface (front face, right and left profiles - Standard 60°, cross polarized, parallel polarized and UV lights)