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

Sponsor
Shenzhen Precision Health Food Technology Co. Ltd., (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05696938
Collaborator
(none)
70
Enrollment
2
Locations
2
Arms
3.6
Anticipated Duration (Months)
35
Patients Per Site
9.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Wonderlab Nicotinamide Drink
  • Dietary Supplement: Ordinary Drink
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
Official Title:
Improved Skin Whitening Outcomes Associated With Nicotinamide Fortified Consumption in 30 to 50-Year-old Women, a Double Blind, Control and Randomized Study
Anticipated Study Start Date :
Feb 9, 2023
Anticipated Primary Completion Date :
May 15, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Skin Brightness [baseline day 0, day 30, day 60]

    The changes of the skin brightness by Spectrophotometer CM2600D

Secondary Outcome Measures

  1. Skin Barrier [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 [baseline day 0, day 30, day 60]

    The changes of skin hydration by Corneometer CM 825

  3. Skin Gloss [baseline day 0, day 30, day 60]

    The changes of skin gloss by Glossmeter

  4. Skin Radiance Scale [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ai'er Hospital Shanghai Shanghai China
2 SPRIM Central Lab Shanghai Shanghai China

Sponsors and Collaborators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Shenzhen Precision Health Food Technology Co. Ltd.,
ClinicalTrials.gov Identifier:
NCT05696938
Other Study ID Numbers:
  • 22-SM-11-WL-001
First Posted:
Jan 25, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shenzhen Precision Health Food Technology Co. Ltd.,
skin whitening
nicotinamide
Additional relevant MeSH terms:
Niacinamide
Niacin
Nicotinic Acids

Study Results

No Results Posted as of Jan 25, 2023