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

April 10, 2023 updated by: Shenzhen Precision Health Food Technology Co. Ltd.,

Improved Skin Whitening Outcomes Associated With Nicotinamide Fortified Consumption in 30 to 50-Year-old Women, a Double Blind, Control and Randomized Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Ai'er Hospital
      • Shanghai, Shanghai, China
        • SPRIM Central Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Dietary supplement: Wonderlab Nicotinamide Drink
Participants in this arm will use a bottle of 25ml each time, twice a day, for 2 months.
Placebo Comparator: Ordinary Drink

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Brightness
Time Frame: baseline day 0, day 30, day 60
The changes of the skin brightness by Spectrophotometer CM2600D
baseline day 0, day 30, day 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin Barrier
Time Frame: baseline day 0, day 30, day 60
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
Time Frame: baseline day 0, day 30, day 60
The changes of skin hydration by Corneometer CM 825
baseline day 0, day 30, day 60
Skin Gloss
Time Frame: baseline day 0, day 30, day 60
The changes of skin gloss by Glossmeter
baseline day 0, day 30, day 60
Skin Radiance Scale
Time Frame: baseline day 0, day 30, day 60
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Precision Health Food Technology Co. Ltd.,

Investigators

  • Principal Investigator: Yun Wang, MD, NO. 9 Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2023

Primary Completion (Anticipated)

April 26, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

January 20, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-SM-11-WL-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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