An 8-week Full Face HUT Clinical Trial for HydroBoost (2.0/3.0)
- Conditions
- Adult Skin Healthy Signs
- Interventions
- Combination Product: Group 3Combination Product: Group 2Combination Product: Group 1
- Registration Number
- NCT03264677
- Lead Sponsor
- Johnson & Johnson Pte Ltd
- Brief Summary
* 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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 122
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 3 Group 3 NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion Group 2 Group 2 NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel Group 1 Group 1 NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel
- Primary Outcome Measures
Name Time Method Skin surface moisture content 9 weeks Skin surface moisture content is measured by skin capacitance measurement.
- Secondary Outcome Measures
Name Time Method Skin softness 9 weeks Dermatologist grading of skin softness
Skin hydration 9 weeks Dermatologist grading of skin hydration
Clogged pores 9 weeks Dermatologist grading of clogged Pores
Life habits 9 weeks Subject's life pattern captured by diary.
Skin translucency 9 weeks Dermatologist grading of skin translucency
Skin microbiome 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.
Skin deep layer moisture content 9 weeks Skin deep layer moisture content by measuring skin dielectric constant.
Temperature 9 weeks Individual temperature measured by portable environmental tracker
PM 2.5 9 weeks Individual PM 2.5 measured by portable environmental tracker
Quality of Life 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
Skin elasticity 9 weeks Dermatologist grading of skin elasticity
Skin smoothness 9 weeks Dermatologist grading of skin smoothness
Subject Self-assessment 9 weeks Subject self-assessment Questionnaire (QN) on product performance
Humidity 9 weeks Individual humidity measured by portable environmental tracker
Skin barrier function 9 weeks TEWL
Skin roughness 9 weeks Skin roughness measurement via skin surface imaging
Skin firmness 9 weeks Dermatologist grading of skin firmness
Skin radiance 9 weeks Dermatologist grading of skin radiance
Pimple 9 weeks Dermatologist grading of pimple
Skin fine lines 9 weeks Dermatologist grading of skin fine lines
Trial Locations
- Locations (1)
Shanghai Skin Disease Hospital
🇨🇳Shanghai, Shanghai, China