Status:
COMPLETED
An 8-week Full Face HUT Clinical Trial for HydroBoost (2.0/3.0)
Lead Sponsor:
Johnson & Johnson Pte Ltd
Collaborating Sponsors:
Shanghai Skin Disease Hospital
Shanghai China-Norm Management Consulting co.,LTD
Conditions:
Adult Skin Healthy Signs
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
* To investigate the product regiments' performance on moisturization related skin healthy signs (skin moisturization, barrier function, elasticity, translucency, roughness and skin conditions) throug...
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 ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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),
- 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.
- Is not a ward of the court or deprived from liberty by a judiciary or administrative decision;
- 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;
- 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
- 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;
- 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;
- Is taking immunosuppressive drugs within 3 months before inclusion and during the study;
- 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.
Exclusion
Key Trial Info
Start Date :
May 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2017
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT03264677
Start Date
May 18 2017
End Date
July 25 2017
Last Update
April 11 2018
Active Locations (1)
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1
Shanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China, 200443