Skin DarkenNCT05696938

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

A study testing Wonderlab Nicotinamide Drink and Ordinary Drink in people with Skin Darken, run by Shenzhen Precision Health Food Technology Co. Ltd., at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 30 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for: Skin Darken
What is being tested?: Wonderlab Nicotinamide Drink and Ordinary Drink
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 70 participants
Where: 2 sitesChina
Study dates: 16 Feb 2023to 26 Apr 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 50 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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;

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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.).

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Ai'er Hospital
Shanghai, Shanghai Municipality
SPRIM Central Lab
Shanghai, Shanghai Municipality

Other trials in China

About this study

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

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.

Read the 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.

Conditions: Skin Darken
Being tested: Wonderlab Nicotinamide Drink, Ordinary Drink
Keywords: skin whitening, nicotinamide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05696938
Study group	Role	What they receive
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 Receives: 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 Receives: Dietary Supplement: Ordinary Drink

What is being measured

The primary outcome is the main question the study is designed to answer.

Skin Brightness
The changes of the skin brightness by Spectrophotometer CM2600D
Measured: baseline day 0, day 30, day 60

Secondary outcomes (4)

Skin Barrier
The changes of skin barrier in terms of TEWL (Trans Epidermal Water Loss) via Aquaflux F200
Measured: baseline day 0, day 30, day 60
Skin Hydration
The changes of skin hydration by Corneometer CM 825
Measured: baseline day 0, day 30, day 60
Skin Gloss
The changes of skin gloss by Glossmeter
Measured: 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
Measured: baseline day 0, day 30, day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 202326 Apr 2023

First posted25 Jan 2023
Study start16 Feb 2023
Primary completion26 Apr 2023
Study completion26 Apr 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Skin DarkenStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05696938
Sponsor's protocol ID: 22-SM-11-WL-001
Status last verified: Nov 2023
First submitted: 27 Dec 2022
Last updated: 24 Nov 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 29405129
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.
PubMed 33394548
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.
PubMed 34958693
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.
PubMed 34313461
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.
PubMed 35785442

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05696938
Acronym / sponsor ID: 22-SM-11-WL-001
Conditions: Skin Darken
Keywords: skin whitening, nicotinamide
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Shenzhen Precision Health Food Technology Co. Ltd.,Other government
Study start: 16 Feb 2023 (actual)
Primary completion: 26 Apr 2023 (actual)
Study completion: 26 Apr 2023 (actual)
First posted: 25 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Wonderlab Nicotinamide Drink	Active comparator	Dietary Supplement: Wonderlab Nicotinamide Drink25ml/bottle, containing the following ingredients per 25ml serving: * Nicotinamide 0.39 mg * Vitamins C 300 mg * Hyaluronic acid 50 mg * Tomato powder 120 mg
Ordinary Drink	Placebo comparator	Dietary Supplement: Ordinary Drink25ml/bottle, containing the following ingredients per 25ml serving: * Litchi juice 0.7 g * Erythritol 2 g * Pectin 0.25 g

Who may qualify

Ages: 30 to 50 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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;

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Wonderlab Nicotinamide DrinkParticipants in this arm will use a bottle of 25ml each time, twice a day, for 2 months.	Dietary supplement	Wonderlab Nicotinamide Drink
Ordinary DrinkParticipants in this arm will use a bottle of 25ml each time, twice a day, for 2 months.	Dietary supplement	Ordinary Drink

Primary outcome

Skin Brightness
Time frame: baseline day 0, day 30, day 60
The changes of the skin brightness by Spectrophotometer CM2600D

4 secondary outcomes

Skin Barrier
Time frame: baseline day 0, day 30, day 60
Skin Hydration
Time frame: baseline day 0, day 30, day 60
Skin Gloss
Time frame: baseline day 0, day 30, day 60
Skin Radiance Scale
Time frame: baseline day 0, day 30, day 60

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
Background: PubMed 29405129Bains 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.
Background: PubMed 33394548Zhao 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.
Background: PubMed 34958693Shariff 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.
Background: PubMed 34313461Wang 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.
Background: PubMed 35785442Du 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yun Wang, MD principal investigator

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Wonderlab Nicotinamide Drink and Ordinary Drink in people with Skin Darken, run by Shenzhen Precision Health Food Technology Co. Ltd., at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Skin Brightness (time frame: baseline day 0, day 30, day 60). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05696938, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.