Clinical trial NCT02981056: A Clinical Assessment of the Efficacy and Effects of Different Skincare Regimens on Infants
Official title: A Clinical Assessment of the Efficacy and Effects of Different Skincare Regimens on Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Baby Skin Development
Keywords: Skincare regimens
Skin moisturization
Skin barrier
Skin development
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
Collaborators: name: Beijing Children's Hospital
name: Shanghai China-Norm Management Consulting co.,LTD
name: Fudan University
name: Shaanxi Bio-regenerative Biotechnology co.LTD
First posted: 2016-12-02
Enrollment: 150
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the study is to investigate the effects of different skincare regimens on infants (0-6 months old at the start of the study), specifically focusing on moisturization effect. Outcome measures include moisturization, skin pH, skin barrier, physiological parameters, reactivity and skin microbiome.

Detailed description: This is a single-center, single-blind, parallel study in healthy, full-term, male or female infants aged 0-6 months at the start of the study. The objective of the study is to investigate the effects of different skincare regimens on infants (0-6 months old at the start of the study), specifically focusing on moisturization effect. Outcome measures include moisturization, skin pH, skin barrier, physiological parameters, reactivity and skin microbiome.

Eligibility criteria: Inclusion Criteria:

1. Study Population: Healthy, full-term, male or female aged 0-6 months old at the start of the study. The newborn must not suffer from any pre-existing conditions (including skin conditions) that can adversely affect the outcome of the study.
2. The participating parent/legal guardian is the one who regularly cares for the newborn. This parent/legal guardian must be willing and able to follow all study directions, accept skin examination and commit to all follow-up visits for the duration of the study. The participating parent/legal guardian must agree to complete a daily diary, as well as questionnaires about use of the test product at each trial visit.

   1. For Cell No.1, the participating parent/legal guardian must be willing to bathe the newborn with the provided baby wash during every bath, at least 5 times a week throughout the remainder of the study. Test wash should be used no more than once in the same day.

      The participating parent/legal guardian must be willing to apply the provided test lotion at least once per day, in the morning. When bathing the newborn, the test lotion should be used after bathing. If the newborn is bathed in the afternoon or evening (at least 6 hours after the first lotion application), the test lotion is to be re-applied after bathing. Test lotion should be used no more than twice in the same day.
   2. For Cell No.2, the participating parent/legal guardian must be willing to bathe the newborn with water only during every bath, at least 5 times a week throughout the remainder of the study.

      The participating parent/legal guardian must be willing to apply the provided test lotion at least once per day, in the morning. When bathing the newborn, the test lotion should be used after bathing. If the newborn is bathed in the afternoon or evening (at least 6 hours after the first lotion application), the test lotion is to be re-applied after bathing. Test lotion should be used no more than twice in the same day.
   3. For Cell No.3, the participating parent/legal guardian must be willing to bathe the newborn with water only during every bath, at least 5 times a week throughout the remainder of the study but not more than once a day.

   The participating parent/legal guardian must be willing to not apply any body moisturizer to the newborn throughout the study.
3. The participating parent/legal guardian must be willing to read an IRB-approved informed consent agreement in Chinese, have all study related questions answered and to sign 2 copies of the agreement on behalf of his/her minor child (1 to retain and 1 for the study file).
4. Participating parent/legal guardian must be willing to complete a medical history and eligibility questionnaire related to his/her child, and to sign a photographic release, and a confidentiality agreement.
5. Participating parent/legal guardian must understand/agree that all of the following inclusion criteria must be met for 1 per household to be enrolled and participate in the study. One newborn in the household is eligible to participate in the study. Newborn is the only subject in the household who will participate in the study and routinely treated with the test materials alone.
6. Participating, adult parent/legal guardian of the subject must be 18 years of age or older and must be willing to present proof of guardianship (i.e., birth certificate, insurance card) at screening/baseline visit.
7. Participating parent/legal guardian must be willing to cooperate and participate by following study requirements for the duration of the study.
8. Participating parent/legal guardian must be willing to not bathe their newborn at least 12 hours prior to each clinic visit and to have the newborn wear loose-fitting clothing to each visit to accommodate procedures.
9. Participating parent/legal guardian must be willing for their newborn to have clean skin on baseline visit and all follow-up visits.
10. Parent/legal guardian must be willing to not apply any product to the newborn for 24 hours before visit until after the visit is completed.
11. Parent/legal guardian must be willing to replace the regular wash and lotion/moisturizer with the assigned products in this trial. Parent/legal guardian must continue to use newborn's regular brand of shampoo (but limit the use of shampoo on head/hair only), wipes/powder, and diaper rash ointment/cream as long as they have been using the product for at least 1 month prior to the start of the study.
12. Parent/legal guardian must agree not to use the provided test products on any other family member (other than the newborn participant) for the duration of the study.
13. Parent/legal guardian must be willing to use the product as a direct-to-skin with hand application. Parent/legal guardian must be willing to use the wash product without pouring it into the bath.
14. Parent/legal guardian must agree not to introduce any new fragrances on his/her person, or on his/her newborn (e.g. cleansers, lotions, perfumes, etc.), or in the household environment (e.g. room fresheners, cleansing agents, etc.) for the duration of the study.
15. Parent/legal guardian must agree not to expose his/her newborn participating in the study to excessive sun exposure. Parent/legal guardian must agree for the newborn to avoid extended sun exposure during the peak periods of 11 AM to 4 PM. If newborn is briefly exposed to the sun, parent/legal guardian will make every attempt to use protective clothing. No use of sunscreen is allowed throughout study participation.
16. Parent/legal guardian must agree not to permit their newborn from participating in another study for the duration of the study.
17. Parent/legal guardian must agree for the newborn to avoid the beach during the course of the study, and any activities at or in a swimming pool should be documented in the daily diary.
18. Evidence of a personally signed and dated Informed Consent document indicating that the Parent/legal guardian has been informed of all pertinent aspects of the trial.
19. Parent/legal guardian who is willing and able to comply with scheduled visits, study procedures, and other trial procedures.

Exclusion Criteria:

1. Any disease or condition of the skin (i.e. dermatitis, eczema, psoriasis, rosacea) that the Investigator deems inappropriate for participation.
2. Any newborn with clinically determined moderate to severe dryness (\>2.0) or clinically determined erythema (\>0.5), rash (\>0.5), or an overall skin condition which, in the Investigator's judgment, makes the subject ineligible or places the subject at risk will not be enrolled in the study.
3. Any condition requiring use of a topical or oral OTC or prescription medication, which, in the investigator's judgment, makes the subject ineligible or places the subject at risk (e.g. antibiotics or any other medications that may cause gastrointestinal distress/diarrhea that will affect skin condition/cause irritation/rash of genital/buttocks area). Child vitamins are allowed and should be listed on the Medical Information sheet under the Concurrent Medications section.
4. Individuals currently involved in another clinical study of any type, or planning to participate in another clinical study of any type during this study.
5. Newborn participant who exhibits or is known to have atopic dermatitis, eczema, or other inflammatory disease, or mild to severe diaper rash or skin diseases/conditions that in the opinion of the investigator may affect the evaluation of study product or place the newborn at undue risk.
6. Newborn participant or parent/legal guardian who has experienced unusual hypersensitivity or allergic reactivity to fragrances and/or reaction/irritation to skin care toiletry products, or who has known allergies/sensitivities to ingredients in the provided test products.
7. Newborn participant or parent/legal guardian with a known condition of asthma or any related breathing problems and/or for whom there is a family history of asthma.
8. Newborn participant with chronic medical conditions or treatments that could interfere with the study or pose a risk to the newborn (including known immunodeficiency or lung related conditions).
9. Newborn participant with active localized or general infections including upper respiratory infections (ear, nose, throat, fever, cough, etc.).
10. Conditions that may interfere with the evaluation of the trial results, e.g., medical characteristics, diseases, or therapy that may interfere with the effect of the investigational product or with the evaluation of efficacy or safety variables. The conditions may also include concurrent use of another investigational product or prior use of an investigational product or approved medication or other drug within a defined period prior to trial enrollment.
11. Conditions for which subjects should be excluded for safety reasons, e.g., medical characteristics, disease, or therapy that may constitute contraindications or risks in connection with the use of the investigational product or the specified methods of evaluation.
12. Participation in other clinical trials within 30 days before the current trial begins and/or during trial participation
13. Other medical conditions that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
14. Parent/Legal guardian of the newborn is an employee of the investigator or study center or is a family member of the employees or the investigator.

Primary outcomes:
measure: Skin surface moisture
timeFrame: 3 months
Secondary outcomes:
measure: Skin deep hydration
timeFrame: 3 months
measure: Trans-epidermis water loss (TEWL)
timeFrame: 3 months
measure: Ratio of TEWL/Skin surface moisture to reflect skin barrier function
timeFrame: 3 months
measure: Skin pH value
timeFrame: 3 months
measure: Skin roughness
timeFrame: 3 months
measure: Dermatological assessments
timeFrame: 3 months
measure: Parent/Caregiver assessments
timeFrame: 3 months
measure: Skin microbiome
timeFrame: 3 months
measure: Skin bio-marker
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Children's Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Children's Hospital
name: Lin Ma, PhD
role: PRINCIPAL_INVESTIGATOR
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