Improved Skin Whitening Outcomes Associated With Nicotinamide Fortified Consumption in 30 to 50- Year-old Women

NCT05696938 | Completed

• 1 other identifier: 22-SM-11-WL-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Skin Darken

Keywords

skin whitening; nicotinamide

Outcome Measures

Primary Outcomes (1)

• Skin Brightness

  The changes of the skin brightness by Spectrophotometer CM2600D

  baseline day 0, day 30, day 60

Secondary Outcomes (4)

• Skin Barrier

  baseline day 0, day 30, day 60

• Skin Hydration

  baseline day 0, day 30, day 60

• Skin Gloss

  baseline day 0, day 30, day 60

• Skin Radiance Scale

  baseline day 0, day 30, day 60

Study Arms (2)

Wonderlab Nicotinamide Drink

ACTIVE COMPARATOR

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

Dietary Supplement: Wonderlab Nicotinamide Drink

Ordinary Drink

PLACEBO COMPARATOR

25ml/bottle, containing the following ingredients per 25ml serving: * Litchi juice 0.7 g * Erythritol 2 g * Pectin 0.25 g

Dietary Supplement: Ordinary Drink

Interventions

Wonderlab Nicotinamide Drink DIETARY_SUPPLEMENT

Participants in this arm will use a bottle of 25ml each time, twice a day, for 2 months.

Wonderlab Nicotinamide Drink

Ordinary Drink DIETARY_SUPPLEMENT

Participants in this arm will use a bottle of 25ml each time, twice a day, for 2 months.

Ordinary Drink

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: must be momen of 30 to 50 years old
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Chinese females, age between 30-50;
• 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.).

You may not qualify if:

• Have used any skin lightening /anti-aging benefits products at least one month before this study
• 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.

Sponsors & Collaborators

• Shenzhen Precision Health Food Technology Co. Ltd.,: lead

Study Sites (2)

Ai'er Hospital

Shanghai, Shanghai Municipality, China

Location

SPRIM Central Lab

Shanghai, Shanghai Municipality, China

Location

Related Publications (5)

• 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.

  PMID: 29405129 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.

  PMID: 33394548 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.

  PMID: 34958693 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.

  PMID: 34313461 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.

  PMID: 35785442 BACKGROUND

Study Officials

• Yun Wang, MD

  NO. 9 Hospital affiliated to Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2022
• First Posted: January 25, 2023
• Study Start: February 16, 2023
• Primary Completion: April 26, 2023
• Study Completion: April 26, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)