Improved Skin Whitening Outcomes Associated With Nicotinamide Fortified Consumption in 30 to 50- Year-old Women
NCT ID: NCT05696938
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
70 participants
INTERVENTIONAL
2023-02-16
2023-04-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Partipants will be randomly assigned to two study groups and use products (study product plus nicotinamide supplement and placebo product without nicotinamide supplement) for 2 months, twice a day.
Researchers will compare the two groups whether there are significant improvement in skin whitening via skin measurement and analysis systems.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Wonderlab Nicotinamide Drink
25ml/bottle, containing the following ingredients per 25ml serving:
* Nicotinamide 0.39 mg
* Vitamins C 300 mg
* Hyaluronic acid 50 mg
* Tomato powder 120 mg
Wonderlab Nicotinamide Drink
Participants in this arm will use a bottle of 25ml each time, twice a day, for 2 months.
Ordinary Drink
25ml/bottle, containing the following ingredients per 25ml serving:
* Litchi juice 0.7 g
* Erythritol 2 g
* Pectin 0.25 g
Ordinary Drink
Participants in this arm will use a bottle of 25ml each time, twice a day, for 2 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Wonderlab Nicotinamide Drink
Participants in this arm will use a bottle of 25ml each time, twice a day, for 2 months.
Ordinary Drink
Participants in this arm will use a bottle of 25ml each time, twice a day, for 2 months.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Be in general good health;
* Understand the test procedure, read, and sign an appropriate Informed Consent Form indicating their willingness to participate;
* Be free from tattoos, cuts, scratches, abrasions, scars, uneven skin tone, sunburn, excessive tanning, open wounds, excessive hair, and visible skin disease on the inner forearm;
* Has the skin lightness parameter L\* \< 60 on the inner forearm the beginning of the product application phase;
* Willing and able to follow all study directions, undergo skin examination and commit to all follow-up visits;
* Individuals in good general health (no physical required) and not taking any prescribed medicines (except for oral contraceptives or asthma inhalers) that could interfere with the conduct of the study;
* Agree to not use any other creams, lotions, moisturizers on the face, other than what is provided for the duration of the study;
* Agree to refrain from wearing make-up (such as foundation, eye shadow, lipstick etc.) or any skin care products on the face on the study visits;
* Agree to avoid washing the treatment site area for two hours following product application and agree to avoid washing appliances (i.e., sponge, wash cloth, loofah, etc.).
Exclusion Criteria
* Subject having done facial injections and/or aesthetic surgery.
* Be involved in any aspect of test administration, i.e., evaluating or overseeing activities related to product.
* Have participated in any clinical study involving the test sites within the previous 6 months, or is subject participating in any clinical study concurrently.
* Have a history of any type of bottlecer, including but not limited to any type of skin bottlecer (squamous or basal cell carcinoma at the treatment site) or history of malignant melanoma at any body site.
* Have a history of skin disease or the presence of a skin condition on the test sites that the Investigator feels would interfere with the study.
* Be taking antihistamines (\> 3x/week) or anti-inflammatory (\> 8x/week) on a regular basis, or has the subject taken systemic or topical steroidal medications within 4 weeks of study enrolment.
* Have any of the following conditions or factors that the investigator believes may affect the response of the skin or the interpretation of the test results, including, but not limited to, diabetes, pregnancy, lactation.
* Have any cuts/abrasions on the test site at baseline.
* Have had a suspicious skin lesion removed by a dermatologist at any time.
* The subject is an employee of sponsor or the site conducting the study.
30 Years
50 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shenzhen Precision Health Food Technology Co. Ltd.,
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yun Wang, MD
Role: PRINCIPAL_INVESTIGATOR
NO. 9 Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ai'er Hospital
Shanghai, Shanghai Municipality, China
SPRIM Central Lab
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Bains P, Kaur M, Kaur J, Sharma S. Nicotinamide: Mechanism of action and indications in dermatology. Indian J Dermatol Venereol Leprol. 2018;84(2):234-237. doi: 10.4103/ijdvl.IJDVL_286_17. No abstract available.
Zhao J, Liu Z, Zhang C, Wu J, Huang N, Du Y, Xiang L. Dynamic evaluation of an in vivo postinflammatory hyperpigmentation model using reflectance confocal microscopy and spectrophotometry. J Cosmet Dermatol. 2021 Sep;20(9):2950-2962. doi: 10.1111/jocd.13932. Epub 2021 Feb 13.
Shariff R, Du Y, Dutta M, Kumar S 5th, Thimmaiah S, Doraiswamy C, Kumari A, Kale V, Nair N, Zhang S, Joshi M, Santhanam U, Qiang Q, Damodaran A. Superior even skin tone and anti-ageing benefit of a combination of 4-hexylresorcinol and niacinamide. Int J Cosmet Sci. 2022 Feb;44(1):103-117. doi: 10.1111/ics.12759. Epub 2022 Feb 1.
Wang L, Xu YN, Chu CC, Jing Z, Chen Y, Zhang J, Pu M, Mi T, Du Y, Liang Z, Doraiswamy C, Zeng T, Wu J, Chen L. Facial Skin Microbiota-Mediated Host Response to Pollution Stress Revealed by Microbiome Networks of Individual. mSystems. 2021 Aug 31;6(4):e0031921. doi: 10.1128/mSystems.00319-21. Epub 2021 Jul 27.
Du Y, Doraiswamy C, Mao J, Zhang Q, Liang Y, Du Z, Vasantharaghavan R, Joshi MK. Facial skin characteristics and concerns in Indonesia: A cross-sectional observational study. Skin Res Technol. 2022 Sep;28(5):719-728. doi: 10.1111/srt.13189. Epub 2022 Jul 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22-SM-11-WL-001
Identifier Type: -
Identifier Source: org_study_id