Efficacy of Topical Niacinamide Riboside on the Signs of Facial Skin Aging (NR-RADIANCE)
2026년 8월 19일 업데이트: 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.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
140
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Manoj Choudhry
- 전화번호: +27 21 204 4886
- 이메일: manoj.choudhry@iecas.co.za
연구 장소
-
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Western Cape
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Cape Town, Western Cape, 남아프리카, 7925
- 모병
- I.E.C. Afrique du Sud
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연락하다:
- Manoj Choudhry
- 전화번호: +021 447 4366
- 이메일: studies@iecas.co.za
-
수석 연구원:
- Manoj Choudhry
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 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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실험적: 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.
다른 이름들:
|
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실험적: 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.
다른 이름들:
|
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실험적: 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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in skin's biological age
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Participant Reported Outcome: Efficacy and acceptability of product
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Skin Imaging
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Manoj Choudhry, IEC Afrique du Sud
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 8월 17일
기본 완료 (추정된)
2026년 12월 4일
연구 완료 (추정된)
2027년 3월 31일
연구 등록 날짜
최초 제출
2026년 8월 16일
QC 기준을 충족하는 최초 제출
2026년 8월 16일
처음 게시됨 (실제)
2026년 8월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 8월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 8월 19일
마지막으로 확인됨
2026년 8월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- C26-Z083
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Data may be made available upon reasonable request following the publication of the primary study results.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .