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The goal of this clinical trial is to study whether the products with nicotinamide fortified could improve skin whitening in 30 to 50-year-old women.
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.
This study is two arms, randomized, double-blind controlled trial. 70 eligible partipants at two study sites will be enrolled and use randomly assigned products (study product plus nicotinamide supplement and placebo product) for 2 months. Participants will visit the study site for three times on baseline day, day 30, and day 60, all relevant data will be captured, measured via professional skin equipment system and recorded in the data management system. At the end of study, the explantory and statisitcal analysis will be conducted to validate the assumption that the using products with nicotinamide fortified could improve skin whitening in 30 to 50-year-old women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wonderlab Nicotinamide Drink | Active Comparator | 25ml/bottle, containing the following ingredients per 25ml serving:
|
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| Ordinary Drink | Placebo Comparator | 25ml/bottle, containing the following ingredients per 25ml serving:
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Wonderlab Nicotinamide Drink | Dietary Supplement | Participants in this arm will use a bottle of 25ml each time, twice a day, for 2 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Skin Brightness | The changes of the skin brightness by Spectrophotometer CM2600D | baseline day 0, day 30, day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Barrier | The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) via Aquaflux F200 | baseline day 0, day 30, day 60 |
| Skin Hydration | The changes of skin hydration by Corneometer CM 825 |
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Inclusion Criteria:
Exclusion Criteria:
must be momen of 30 to 50 years old
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| Name | Affiliation | Role |
|---|---|---|
| Yun Wang, MD | NO. 9 Hospital affiliated to Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ai'er Hospital | Shanghai | Shanghai Municipality | China | |||
| SPRIM Central Lab |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29405129 | Background | 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. | |
| 33394548 | Background | 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. |
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| Ordinary Drink | Dietary Supplement | Participants in this arm will use a bottle of 25ml each time, twice a day, for 2 months. |
|
| baseline day 0, day 30, day 60 |
| Skin Gloss | The changes of skin gloss by Glossmeter | baseline day 0, day 30, day 60 |
| Skin Radiance Scale | The changes of skin radiance scale (0-9) assessed in three aspects (Radiant Lumimous,Shallowness, and Dullness) by professionals | baseline day 0, day 30, day 60 |
| Shanghai |
| Shanghai Municipality |
| China |
| 34958693 | Background | 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. |
| 34313461 | Background | 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. |
| 35785442 | Background | 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. |