Efficacy of Topical Niacinamide Riboside on the Signs of Facial Skin Aging (NR-RADIANCE)
keskiviikko 19. elokuuta 2026 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Rekrytointi
Interventio / Hoito
Opintotyyppi
Interventio
Ilmoittautuminen (Arvioitu)
140
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskeluyhteys
- Nimi: Manoj Choudhry
- Puhelinnumero: +27 21 204 4886
- Sähköposti: manoj.choudhry@iecas.co.za
Opiskelupaikat
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Western Cape
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Cape Town, Western Cape, Etelä-Afrikka, 7925
- Rekrytointi
- I.E.C. Afrique du Sud
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Ottaa yhteyttä:
- Manoj Choudhry
- Puhelinnumero: +021 447 4366
- Sähköposti: studies@iecas.co.za
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Päätutkija:
- Manoj Choudhry
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Joo
Kuvaus
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.
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Muut
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
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Placebo Comparator: Placebo
The participants randomized to this group will receive a product that results in 0% of NR per application.
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Topical Skin Care Product: Placebo prepared in a a dry nanofiber pillow, applied topically to the face, twice daily for 12 weeks.
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Kokeellinen: 2.5% NR
The participants randomized to this group will receive a product that results in approximately 2.5% of NR per application.
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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.
Muut nimet:
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Kokeellinen: 5% NR
The participants randomized to this group will receive a product that results in approximately 5% of NR per application.
|
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.
Muut nimet:
|
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Kokeellinen: 10% NR
The participants randomized to this group will receive a product that results in approximately 10% of NR per application.
|
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.
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Change in skin's biological age
Aikaikkuna: baseline and day 84
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Dermal curette sampling of the skin at baseline and day 84 to evaluate changes in epigenetic markers of skin aging.
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baseline and day 84
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Quantitative change in fine lines and wrinkles
Aikaikkuna: baseline and days 28, 56, and 84
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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."
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baseline and days 28, 56, and 84
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Quantitative changes in skin firmness and tightness
Aikaikkuna: baseline and days 56 and 84
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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.
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baseline and days 56 and 84
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Participant Reported Outcome: Efficacy and acceptability of product
Aikaikkuna: baseline and days 14, 28, 42, 56, and 84
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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.
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baseline and days 14, 28, 42, 56, and 84
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Adverse Event Monitoring
Aikaikkuna: Up to two weeks after study completion
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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.
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Up to two weeks after study completion
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Skin hydration
Aikaikkuna: baseline and day 28
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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.
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baseline and day 28
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Moisture retention
Aikaikkuna: baseline and day 28
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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.
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baseline and day 28
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Skin barrier integrity
Aikaikkuna: baseline and day 28
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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.
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baseline and day 28
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Pores
Aikaikkuna: baseline and days 28, 56, and 84
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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.
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baseline and days 28, 56, and 84
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Texture/smoothness
Aikaikkuna: baseline and days 28, 56, and 84
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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."
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baseline and days 28, 56, and 84
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Skin tone evenness
Aikaikkuna: baseline and days 28, 56, and 84
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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."
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baseline and days 28, 56, and 84
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Skin plumpness
Aikaikkuna: baseline and days 28, 56, and 84
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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."
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baseline and days 28, 56, and 84
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Radiance
Aikaikkuna: baseline and days 28, 56, and 84
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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."
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baseline and days 28, 56, and 84
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Redness
Aikaikkuna: baseline and days 28, 56, and 84
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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."
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baseline and days 28, 56, and 84
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Firmness
Aikaikkuna: baseline and days 28, 56, and 84
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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.""
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baseline and days 28, 56, and 84
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Skin Imaging
Aikaikkuna: baseline and days 28, 56, and 84
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Illustrative high-resolution digital photographs with Colorface (front face, right and left profiles - Standard 60°, cross polarized, parallel polarized and UV lights)
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baseline and days 28, 56, and 84
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Participant Reported Outcome: Skin redness
Aikaikkuna: baseline and days 14, 28, 42, 56, and 84
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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.
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baseline and days 14, 28, 42, 56, and 84
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Participant Reported Outcome: Irritation post application
Aikaikkuna: baseline and days 14, 28, 42, 56, and 84
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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.
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baseline and days 14, 28, 42, 56, and 84
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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Tutkijat
- Päätutkija: Manoj Choudhry, IEC Afrique du Sud
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
Yleiset julkaisut
- Massudi H, Grant R, Braidy N, Guest J, Farnsworth B, Guillemin GJ. Age-associated changes in oxidative stress and NAD+ metabolism in human tissue. PLoS One. 2012;7(7):e42357. doi: 10.1371/journal.pone.0042357. Epub 2012 Jul 27.
- Pinnagoda J, Tupker RA, Agner T, Serup J. Guidelines for transepidermal water loss (TEWL) measurement. A report from the Standardization Group of the European Society of Contact Dermatitis. Contact Dermatitis. 1990 Mar;22(3):164-78. doi: 10.1111/j.1600-0536.1990.tb01553.x.
- Idoine, R.; Amini-Nik, S.; Mavoyan, J.; Nkrumah-Elie, Y.; Diaz, J.; Shioya, E. Irritation Potential and Acute Efficacy of Topically Applied Niagen® (Niacinamide Riboside Chloride). Preprints 2026, 2026031657. https://doi.org/10.20944/preprints202603.1657.v1
- Wilhelm KP, Cua AB, Maibach HI. In vivo study on age-related elastic properties of human skin. In Noninvasive Methods for the Quantification of Skin Functions: An Update on Methodology and Clinical Applications 1993 (pp. 190-203). Berlin, Heidelberg: Springer Berlin Heidelberg.
- Loden M. Biophysical properties of dry atopic and normal skin with special reference to effects of skin care products. Acta Derm Venereol Suppl (Stockh). 1995;192:1-48. doi: 10.2340/00015555192148.
Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
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Ensimmäinen lähetetty
Sunnuntai 16. elokuuta 2026
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Sunnuntai 16. elokuuta 2026
Ensimmäinen Lähetetty (Todellinen)
Keskiviikko 19. elokuuta 2026
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Perjantai 21. elokuuta 2026
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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Viimeksi vahvistettu
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Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- C26-Z083
Yksittäisten osallistujien tietojen suunnitelma (IPD)
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EI
IPD-suunnitelman kuvaus
Data may be made available upon reasonable request following the publication of the primary study results.
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