A Randomized Pilot Clinical Assessment Of Three Skincare Regimens On Skin Conditions In Infants

Abstract

Introduction

Few data are available on the comparison between the effects on infant skin of skin care products and those of water alone.

Patients and methods

In this single-center, evaluator-blind, parallel-group pilot study, healthy infants were randomized to near-daily washing for 12 weeks (starting in the summer and finishing in the winter months) with a mild liquid baby wash followed by use of baby lotion (wash+lotion), water followed by baby lotion (water+lotion), or water alone. Clinical and instrumental assessments of skin moisturization and barrier function were made.

Results

As expected the skin condition in all groups was affected by the change of the season. The skin of infants in all groups was mildly deteriorated (clinical grading) and with reduced moisture levels and increased barrier function. Instrumental measurements indicated that skin moisture and barrier function were better maintained in the wash+lotion and water+lotion groups than in the water-only group at week 12. Clinical assessment scores increased slightly over 12 weeks in all groups (P<0.05). At week 12, the wash+lotion group (n = 44) had significantly less change from baseline in overall skin condition and softness (lower scores) than did the water+lotion (n = 43) or water-only (n = 43) groups. The wash+lotion regimen maintained stable erythema and rash scores with lower mean values over time than in the other groups.

Conclusion

A regimen of a liquid baby wash and a baby skin lotion for 12 weeks resulted in less detrimental changes in instrumental and clinical measures of skin than using water and lotion or water alone.

Keywords:

• skin abnormalities
• erythema
• exanthema
• emollients
• infant

Acknowledgments

The authors wish to thank the families of the study subjects for participating in this study. The authors want to thank Yujin Saito from Johnson & Johnson International Pte. Ltd., as he was part of the team conceiving the project. Medical writing and editorial support were provided by David Macari, PhD and Alex Loeb, PhD, CMPP, for Evidence Scientific Solutions, Inc. (Philadelphia, PA) and was funded by Johnson & Johnson Consumer Inc. (Skillman, NJ). The authors also want to thank Xi Li from Johnson & Johnson AP Skin Testing Center and Georgios Stamatas from Johnson & Johnson France for helpful comments as well as Min Qiu and Yanwen Jiang from Shanghai China-Norm Management Consulting CO., LTD, who provided statistical analysis support.

Data Sharing Statement

Any requests for data sharing should be submitted through the corresponding author, Carlos Galzote, at [email protected].

Author Contributions

All authors contributed to data analysis, drafting and revising the article, gave final approval of the version to be published, and agree to be accountable for all aspects of the work.

Disclosure

YYD, CG, and F-QK were employees of Johnson & Johnson at the time this study was conducted. YYD and F-QK are no longer employed at Johnson & Johnson. C-PS and LM received research support in association with this study. The authors report no other conflicts of interests in this work.

Additional information

Funding

This study was funded by Johnson & Johnson International Pte. Ltd (Singapore).