Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, 200443, China
NCT Number: NCT03264677
* To investigate the product regiments' performance on moisturization related skin healthy signs (skin moisturization, barrier function, elasticity, translucency, roughness and skin conditions) through instrumental evaluation, clinical grading and self-assessment before, during and after 8 weeks' home usage under city environmental aggressors (Sun, change of temperature and humidity, wind and air pollution) among 3 product regimens and Non-treatment control; * To explore the linkage among products efficacy, ambient aggressors, and life habits; * To investigate product regimens' tolerance and safety via Home Use Test; * To collect skin microflora/microbiome samples for potential research on skin microbiome distribution change as impacted by product application and/or environmental aggressors change (data will be analyzed and reported separately).
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200443, China
This is a single center, double blinded, controlled and randomized 8-week home use clinical trial.
Subjects will be randomly and evenly divided into 3 groups (40subjects/group) with different facial care regimens during the 8-week home use study.
Group 1: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel Group 2: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel Group 3: NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion There will be a 3-day wash-in period after subject's enrollment. During the period, no product will be allowed to be applied on the face and upper chest but only water washes twice per day in the morning and evening for 3 days before baseline (BL) measurement.
After baseline (BL) measurement, the product regimens will be applied on face at site under site instruction according to the randomization. Measurements will be taken at 2-4 hours and 8 hours after product regimens' application. Upper chest area will be measured as no treatment control.
A set of product regimen includes a facial cleanser and a facial cream will be distributed to each subject according to grouping and applied on the face at home for 8 weeks. Both cleanser and cream products will be applied twice a day in the morning and evening on the whole face. For the upper chest area, use water wash only twice per day in the morning and evening, no any other product is allowed.
The usage of assigned product regimens will be discontinued after 8-week home use, no any other product is allowed but only water wash twice per day in the morning and evening on both face and upper chest for 3 days (regression period).
Subjects will not be allowed to use sunscreen, makeup and any other cosmetic products on face and upper chest during the study period.
Subjects will visit the site at Screening (-3D), Baseline (BL), 1-week (1W), 4-week (4W), 8-week (8W) and 8-week+3-days (+3D) for measurements.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel
Other names: HB Cleanser+Kiwi Water Gel
NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel
Other names: HB Cleanser+HB Water Gel
NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion
Other names: HB Cleanser+HB ED Emulsion
Time frame: 9 weeks
Skin surface moisture content is measured by skin capacitance measurement.
Time frame: 9 weeks
In this study, an evaluation tool will be used to measure and quantify skin dryness related Quality of Life (QoL) attributes, to get an understanding of the improvement (related to moisturization benefits) after treatment of skin care regimens
Time frame: 9 weeks
Subject self-assessment Questionnaire (QN) on product performance
Time frame: 9 weeks
Individual temperature measured by portable environmental tracker
Time frame: 9 weeks
Individual humidity measured by portable environmental tracker
Time frame: 9 weeks
Individual PM 2.5 measured by portable environmental tracker
Time frame: 9 weeks
To collect skin microflora/microbiome samples for potential research on skin microbiome distribution change as impacted by product application and/or environmental aggressors change.
Time frame: 9 weeks
Subject's life pattern captured by diary.
Time frame: 9 weeks
TEWL
Time frame: 9 weeks
The mechanical property of the epidermis is measured by a non-invasive, in vivo suction skin elasticity meter.
Time frame: 9 weeks
Skin roughness measurement via skin surface imaging
Time frame: 9 weeks
Many common materials transmit and scatter light but are neither transparent or opaque. Such materials are described as translucent and the degree of translucency depends on the absorption and scattering coefficients of the material. In this study, the degree of skin translucency is quantified by the rate of lateral scatter of light and the total amount of backscattered light, which captured by a non-invasive Translucency Meter probe.
Time frame: 9 weeks
Skin deep layer moisture content by measuring skin dielectric constant.
Time frame: 9 weeks
Dermatologist grading of skin firmness
Time frame: 9 weeks
Dermatologist grading of skin elasticity
Time frame: 9 weeks
Dermatologist grading of skin radiance
Time frame: 9 weeks
Dermatologist grading of skin smoothness
Time frame: 9 weeks
Dermatologist grading of skin fine lines
Time frame: 9 weeks
Dermatologist grading of skin softness
Time frame: 9 weeks
Dermatologist grading of skin hydration
Time frame: 9 weeks
Dermatologist grading of skin translucency
Time frame: 9 weeks
Dermatologist grading of pimple
Time frame: 9 weeks
Dermatologist grading of clogged Pores
Johnson & Johnson Pte Ltd
Industry
An 8-week Full Face HUT Design, Single Center, Double Blinded, Controlled and Randomized Study to Evaluate Different Product Regimens' Performance on Protecting Skin With Resilience Under Tracked City Environmental Aggressors
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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.