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

Shenzhen Precision Health Food Technology

Status: Completed

Conditions: Skin Darken

Treatments: Dietary Supplement: Ordinary Drink; Dietary Supplement: Wonderlab Nicotinamide Drink

Study type: Interventional

Funder types: Other

Identifiers

NCT05696938

22-SM-11-WL-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

Wonderlab Nicotinamide Drink

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Wonderlab Nicotinamide Drink

Ordinary Drink

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Ordinary Drink