Skip to main content
OpenTrials
Completed

NCT Number: NCT05696938

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ai'er Hospital, Shanghai, Shanghai Municipality, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wonderlab Nicotinamide Drink

Dietary Supplement

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

Ordinary Drink

Dietary Supplement

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

Primary outcomes

  1. Skin Brightness

    Time frame: baseline day 0, day 30, day 60

    The changes of the skin brightness by Spectrophotometer CM2600D

Secondary outcomes

  1. 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

  2. Skin Hydration

    Time frame: baseline day 0, day 30, day 60

    The changes of skin hydration by Corneometer CM 825

  3. Skin Gloss

    Time frame: baseline day 0, day 30, day 60

    The changes of skin gloss by Glossmeter

  4. 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

Sponsors and collaborators

Lead sponsor

Shenzhen Precision Health Food Technology Co. Ltd.,

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 25, 2023
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.