I.E.C. Afrique du Sud
Cape Town, Western Cape, 7925, South Africa
NCT Number: NCT07774000
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+). NAD+ is believed to be involved in more than 500 processes that support and maintain cellular health, including DNA damage repair, cell to cell communication, and the regulation of gene expression. NAD+ is found in every living cell and involves redundant pathways to ensure its maintenance. These pathways include the cellular uptake of endogenous and dietary precursors, such as NR for the maintenance of NAD+.
NAD+ is essential for cellular resilience and function. When cells are stressed from various metabolic insults, including environmental exposures such as ultraviolet radiation, NAD+ levels can decrease, impacting cellular health and efficiency. Leading NAD+ researchers propose that as we age, the longitudinal accumulation of metabolic stressors results in an NAD+ decline with age. Research published by Maussudi et al. 2012 (https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0042357) 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 increasing skin NAD+ may be a strategy to combat the 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.
This study will explore if topically applied NR will reduce the signs of skin aging, resulting in healthier, more youthful appearing skin over 12 weeks. The goal of this observational clinical trial is to determine 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 percentage of NR is an estimate based on final concentration of the applied material when mixed in serum.
Twice daily, study participants will apply the test product freshly dissolved in the standardized gel serum to clean facial skin for 84 days. Additionally, all participants will use a standardized skin care regimen including a cleanser, moisturizer, and UV protecting serum for the duration of the study. 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.
Trial opening soon.
Get Notified30 year–60 year
Female
Interventional
Not applicable
Cape Town, Western Cape, 7925, South Africa
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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 for crows 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, a dry and rough skin, visible pores, skin sagging).
Subject is not currently using NAD+ or other 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 the areas of concern 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 areas of concern during the 4 weeks before the starting day of the study;
Subject having modified his/her cosmetic habits (on the areas concerned 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.
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.
Other names: Niagen NanoCloud, Nicotinamide riboside
Topical Skin Care Product: Placebo prepared in a a dry nanofiber pillow, applied topically to the face, twice daily for 12 weeks.
Time frame: baseline and day 84
Dermal curette sampling of the skin at baseline and day 84 to evaluate changes in epigenetic markers of skin aging.
Time frame: baseline and days 28, 56, and 84
Clinical grading of wrinkles in crow's feet area and under eye area
Time frame: baseline and days 56 and 84
Changes in skin firmness and tightness will be measured by cutometer
Time frame: baseline and day 28
Skin hydration as measured by the corneometer and the tewameter
Time frame: baseline and day 28
Moisture retention is measured by a tewameter
Time frame: baseline and day 28
Skin barrier integrity is measured by tewameter
Time frame: baseline and days 28, 56, and 84
Clinical grading of pores
Time frame: baseline and days 28, 56, and 84
Skin texture/smoothness is measured by an expert grader
Time frame: baseline and days 28, 56, and 84
Changes in the appearance of dark spots/hyperpigmentation will be measured by an expert grader
Time frame: baseline and days 28, 56, and 84
Skin plumpness will be measured by clinical grading
Time frame: baseline and days 28, 56, and 84
Skin radiance will be measured by clinical grading
Time frame: baseline and days 28, 56, and 84
Facial skin redness will be measured by clinical grading
Time frame: baseline and days 28, 56, and 84
Skin firmness will be measured by clinical grading
Time frame: 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.
Time frame: 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.
Time frame: baseline and days 28, 56, and 84
Clinical grading of skin redness on the face
Time frame: baseline and days 14, 28, 42, 56, and 84
Self-assessment questionnaires regarding perceived skin irritation at post-application and days 28, 56 and 84 in clinic, and at days 14 and 42 at home.
Time frame: 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)
Contact information is provided by the study sponsor or research team.
ChromaDex, Inc.
Industry
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
Acronym: NR-RADIANCE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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