A Clinical Assessment of the Efficacy and Effects of Different Skincare Regimens on Infants

Johnson & Johnson Consumer and Personal Products Worldwide1 site in 1 country150 target enrollmentJune 2013

ConditionsBaby Skin Development

Overview

Phase: N/A
Intervention: Not specified
Conditions: Baby Skin Development
Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Enrollment: 150
Locations: 1
Primary Endpoint: Skin surface moisture
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2013

End Date

November 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johnson & Johnson Consumer and Personal Products Worldwide

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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.
•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.
•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.
•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.
•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).
•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.

Exclusion Criteria

•Any disease or condition of the skin (i.e. dermatitis, eczema, psoriasis, rosacea) that the Investigator deems inappropriate for participation.
•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.
•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.
•Individuals currently involved in another clinical study of any type, or planning to participate in another clinical study of any type during this study.
•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.
•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.
•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.
•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).
•Newborn participant with active localized or general infections including upper respiratory infections (ear, nose, throat, fever, cough, etc.).
•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.