Clinical trial NCT03264677: An 8-week Full Face HUT Clinical Trial for HydroBoost (2.0/3.0)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adult Skin Healthy Signs
Keywords: 8-week HUT
Hydro Boost
Skin healthy signs
Environmental aggressors
Cosmetic
Lead sponsor: Johnson & Johnson Pte Ltd
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Skin Disease Hospital
name: Shanghai China-Norm Management Consulting co.,LTD
First posted: 2017-08-29
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly and evenly divided into 3 groups (approx. 40 subjects per 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
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria

1. Chinese Females aged 18 - 40 years old in good physical and mental condition;
2. Self-perceived dry facial skin without lesions. Corneometer score ≤35 arbitrary units on both sides of cheek areas;
3. Having daily routine skin exposure (out-door activities) to city environmental challenge and having concern on its impact to healthy skin signs (e.g. Smoothness, Firmness, Translucency, Trouble (pimple, acne) free, Plumpness, etc.);
4. Willing to stay in Shanghai City during the whole study period without travel plan;
5. Having mild to moderate pre-aging sign, e.g. fine line, roughness when skin is dry. Having skin dullness concern on the face;
6. Non-regular body moisturizer user. Expose the upper-chest site during study;
7. Willing to comply with the study instruction (see Appendix IX);
8. Agree to use only water to wash face and upper chest, avoid using any cosmetic products (include but not limited to: wash/ soap/ moisturizer/ toner/ sparge/ sunscreen/ oil/ (water) mask/ scrub/ makeup/ fragrance/ light treatment/ massage, etc.) in the evening before each visit day. No washing on face and upper chest and no product application at home in the morning of the visit day. Subjects will wash the test areas when arrive the test site according to the site instruction;
9. After enrollment, there will be a 3-day wash-in period, during which subjects agree to use water only to wash the face and upper chest twice per day in the morning and evening. Avoid using any cosmetic products as listed in above item 8 in both test areas;
10. Then an 8-week home use period will follow, during which subjects agree to use the assigned product regimens (facial cleanser and facial cream) on face twice per day in the morning and evening. Use water only to wash the upper chest twice per day in the morning and evening. Avoid using any cosmetic products as listed in above item 8 in both test areas;
11. After the 8-week home use of the assigned product regimens, subjects will stop using the products for 3 days (Regression period). Subjects agree to use water only to wash the face and upper chest twice per day in the morning and evening during the period. Avoid using any cosmetic products as listed in above item 8 in both test areas;
12. Generally in good health based on medical history reported by the subject;
13. 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:

      * Is post-menopausal (amenorrhea for at least 1 year),
      * Had a surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal occlusion, hysterectomy, bilateral oophorectomy or salpingectomy)
    * 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:

      * Established use of hormonal methods of contraception (oral, injected, implanted, hormone patch or vaginal ring).
      * Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps),
      * Intrauterine device or intrauterine system,
      * Abstinence from intercourse that could cause pregnancy. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
14. Is not a ward of the court or deprived from liberty by a judiciary or administrative decision;
15. Able to read, write, speak and understand Chinese language or able to speak and understand Chinese language and accompanied by an impartial witness who can read, write, speak and understand Chinese language;
16. Individual that has signed the Consent for Photograph Release (7-8 subjects/group) and ICD including portable tracker using and reporting as instruction;

Exclusion Criteria

1. Participated in any cosmetic clinical test involving facial and/or body product application within 3 months before enrollment.
2. Has known allergies or adverse reactions to common topical skincare products;
3. Presents with a skin condition that may influence the outcome of the study (e.g., psoriasis, eczema, melanomas), primary/secondary lesions on test sites (e.g. erythema, scars, ulcers, vesicles);
4. Has a self-reported uncontrolled metabolic condition or disease, such as diabetes, hypertension, hyper/hypothyroidism, hypercholesterolemia, asthma, epilepsy, etc. Individuals with a controlled health condition may also be excluded from the study at the discretion of the PI, if medically qualified, or the designated study physician;
5. Is taking medication for a chronic condition (e.g., insulin, antihistamines, steroidal and non-steroidal anti-inflammatory drugs, antibiotics, etc.) or is taking any other medication that could influence the study results and/or affect the individual's safety, within 30 days before inclusion or during the study;
6. Is taking immunosuppressive drugs within 3 months before inclusion and during the study;
7. Has a history of or concurrent health condition/situation which, in the opinion of the PI, if medically qualified, or the designated study physician, may put the individual at significant risk, confound the study results, or interfere significantly with the individual's participation in the study;
8. Is simultaneously participating in any other type of clinical study;
9. Is an employee/contractor or immediate family member of the PI, Study Site staff or Sponsor.

Primary outcomes:
measure: Skin surface moisture content
timeFrame: 9 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: 9 weeks
measure: Subject Self-assessment
timeFrame: 9 weeks
measure: Temperature
timeFrame: 9 weeks
measure: Humidity
timeFrame: 9 weeks
measure: PM 2.5
timeFrame: 9 weeks
measure: Skin microbiome
timeFrame: 9 weeks
measure: Life habits
timeFrame: 9 weeks
measure: Skin barrier function
timeFrame: 9 weeks
measure: Skin elasticity
timeFrame: 9 weeks
measure: Skin roughness
timeFrame: 9 weeks
measure: Skin translucency
timeFrame: 9 weeks
measure: Skin deep layer moisture content
timeFrame: 9 weeks
measure: Skin firmness
timeFrame: 9 weeks
measure: Skin elasticity
timeFrame: 9 weeks
measure: Skin radiance
timeFrame: 9 weeks
measure: Skin smoothness
timeFrame: 9 weeks
measure: Skin fine lines
timeFrame: 9 weeks
measure: Skin softness
timeFrame: 9 weeks
measure: Skin hydration
timeFrame: 9 weeks
measure: Skin translucency
timeFrame: 9 weeks
measure: Pimple
timeFrame: 9 weeks
measure: Clogged pores
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Skin Disease Hospital
name: Chao Yuan
role: PRINCIPAL_INVESTIGATOR
References: