An interventional study of Group 1 and Group 2 in Adult Skin Healthy Signs, sponsored by Johnson & Johnson Pte Ltd. Completed at 1 site in China. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-11.
Sponsored by Johnson & Johnson Pte Ltd · Not applicable, Interventional, and Other
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.
Female subjects must meet one of the following criteria:
Is not of child-bearing potential or is in a monogamous relationship with a partner who is not of child-bearing potential, meaning the subject and/or partner:
Must agree to practice a medically acceptable form of birth control during the study and for 30 days after study completion. Female subjects must have used such birth control for at least 3 months prior to study start. Medically acceptable forms of birth control that may be used by the subject and/or partner include:
Exclusion Criteria
NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel
Combination Product: Group 1
NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel
Combination Product: Group 2
NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion
Combination Product: Group 3
NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel
Also known as: HB Cleanser+Kiwi Water Gel
NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel
Also known as: HB Cleanser+HB Water Gel
NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion
Also known as: HB Cleanser+HB ED Emulsion
Skin surface moisture content
Skin surface moisture content is measured by skin capacitance measurement.
Time frame: 9 weeks
Quality of Life
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
Subject self-assessment Questionnaire (QN) on product performance
Time frame: 9 weeks
Temperature
Individual temperature measured by portable environmental tracker
Time frame: 9 weeks
Humidity
Individual humidity measured by portable environmental tracker
Time frame: 9 weeks
PM 2.5
Individual PM 2.5 measured by portable environmental tracker
Time frame: 9 weeks
Skin microbiome
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
Life habits
Subject's life pattern captured by diary.
Time frame: 9 weeks
Skin barrier function
TEWL
Time frame: 9 weeks
Skin elasticity
The mechanical property of the epidermis is measured by a non-invasive, in vivo suction skin elasticity meter.
Time frame: 9 weeks
Skin roughness
Skin roughness measurement via skin surface imaging
Time frame: 9 weeks
Skin translucency
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
Skin deep layer moisture content by measuring skin dielectric constant.
Time frame: 9 weeks
Skin firmness
Dermatologist grading of skin firmness
Time frame: 9 weeks
Skin elasticity
Dermatologist grading of skin elasticity
Time frame: 9 weeks
Skin radiance
Dermatologist grading of skin radiance
Time frame: 9 weeks
Skin smoothness
Dermatologist grading of skin smoothness
Time frame: 9 weeks
Skin fine lines
Dermatologist grading of skin fine lines
Time frame: 9 weeks
Skin softness
Dermatologist grading of skin softness
Time frame: 9 weeks
Skin hydration
Dermatologist grading of skin hydration
Time frame: 9 weeks
Skin translucency
Dermatologist grading of skin translucency
Time frame: 9 weeks
Pimple
Dermatologist grading of pimple
Time frame: 9 weeks
Clogged pores
Dermatologist grading of clogged Pores
Time frame: 9 weeks
Plan to share: No
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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