Tolerability of a Skin Care Regimen Formulated for Acne-Prone Skin in Children.

BACKGROUND

The epidemiology and demographic profile of acne vulgaris has evolved over the past several decades, with a noted earlier onset occurring in patients as young as 7 years of age. The combination of a foaming facial wash and a facial moisturizer with a sun protection factor (SPF) of 30 is an over-the-counter cleansing and moisturizing regimen for acne-prone skin that has been shown to be safe and tolerable in subjects 12 years of age and older.

OBJECTIVES

To assess the tolerability of this skin care regimen in children ages 7 to 11 years with acne-prone skin.

METHODS

This was an open-label, single-center study that investigated the safety and tolerability of these products in subjects 7 to 11 years of age (ClinicalTrials.gov, NCT01909713). Subjects used the foaming wash twice daily and the SPF 30 moisturizer once daily. Subjects were assessed for cutaneous tolerability, and satisfaction at baseline and weeks 1 and 3.

RESULTS

Thirty-five subjects enrolled and completed the study. The cutaneous tolerability score of most subjects was none when assessed by the investigator and subject or legally authorized representative at weeks 1 and 3. The products were well tolerated and a positive impression for cosmetic acceptability was reported for both products by the study population on the questionnaire.

CONCLUSIONS

This study supports the use of a skin care regimen comprising a wash and a moisturizer in acne-prone patients as young as 7 years old since these products were safe, well tolerated, and liked by subjects.