NCT03264677

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 18, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2017

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 29, 2017

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2018

Enrollment Period

2 months

First QC Date

July 24, 2017

Last Update Submit

April 10, 2018

Conditions

Adult Skin Healthy Signs

Keywords

8-week HUTHydro BoostSkin healthy signsEnvironmental aggressorsCosmetic

Outcome Measures

Primary Outcomes (1)

  • Skin surface moisture content

    Skin surface moisture content is measured by skin capacitance measurement.

    9 weeks

Secondary Outcomes (22)

  • Quality of Life

    9 weeks

  • Subject Self-assessment

    9 weeks

  • Temperature

    9 weeks

  • Humidity

    9 weeks

  • PM 2.5

    9 weeks

  • +17 more secondary outcomes

Study Arms (3)

Group 1

EXPERIMENTAL

NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel

Combination Product: Group 1

Group 2

EXPERIMENTAL

NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel

Combination Product: Group 2

Group 3

EXPERIMENTAL

NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion

Combination Product: Group 3

Interventions

Group 1COMBINATION_PRODUCT

NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel

Also known as: HB Cleanser+Kiwi Water Gel
Group 1
Group 2COMBINATION_PRODUCT

NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel

Also known as: HB Cleanser+HB Water Gel
Group 2
Group 3COMBINATION_PRODUCT

NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion

Also known as: HB Cleanser+HB ED Emulsion
Group 3

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsChinese Females
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Chinese Females aged 18 - 40 years old in good physical and mental condition;
  • Self-perceived dry facial skin without lesions. Corneometer score ≤35 arbitrary units on both sides of cheek areas;
  • 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.);
  • Willing to stay in Shanghai City during the whole study period without travel plan;
  • Having mild to moderate pre-aging sign, e.g. fine line, roughness when skin is dry. Having skin dullness concern on the face;
  • Non-regular body moisturizer user. Expose the upper-chest site during study;
  • Willing to comply with the study instruction (see Appendix IX);
  • 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;
  • 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;
  • 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;
  • 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;
  • Generally in good health based on medical history reported by the subject;
  • 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),
  • +9 more criteria

You may not qualify if:

  • Participated in any cosmetic clinical test involving facial and/or body product application within 3 months before enrollment.
  • Has known allergies or adverse reactions to common topical skincare products;
  • 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);
  • 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;
  • 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;
  • Is simultaneously participating in any other type of clinical study;
  • Is an employee/contractor or immediate family member of the PI, Study Site staff or Sponsor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Skin Disease Hospital

Shanghai, Shanghai Municipality, 200443, China

Location

Related Links

Study Officials

  • Chao Yuan

    Shanghai Skin Disease Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Since this will be a blind study, the product randomization codes will be generated by study team member different from Study Manager, Study Director, Principle Investigator and any data producers or influencer. The product randomization codes and the corresponding product information (i.e. product name, formula number, batch number, manufacturing/expiry date, etc.) will be sealed in an envelope and before study filed work complete kept by PI until there is a unblinding needs due to medical emergency or report drafting. In this study, in total 4 IPs include 3 facial creams and 1 facial cleanser will be evaluated. Subjects will be assigned to 3 groups randomly and evenly with different facial product regimens (one cleanser + one cream). The product regimens will be applied on the whole face for on-site study and the 8-week HUT. For each subject, left or right cheek area will be randomly chosen as experimental area for evaluation and middle upper chest will be the untreated control area
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2017

First Posted

August 29, 2017

Study Start

May 18, 2017

Primary Completion

July 25, 2017

Study Completion

July 25, 2017

Last Updated

April 11, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)