title: Tolerability of a Skin Care Regimen Formulated for Acne-Prone Skin in Children.
abstract: 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.
  
  
  OBJECTIVE
  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.
authors.affiliation: Metroplex Dermatology, Arlington, Texas.
authors.forename: David
authors.initials: D
authors.lastname: Hensley
authors.affiliation: Galderma Laboratories, L.P., Fort Worth, Texas.
authors.forename: Matthew H
authors.initials: MH
authors.lastname: Meckfessel
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000287:Administration, Topical; D002648:Child; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D012720:Severity of Illness Index; D017592:Skin Care / Q000379:methods*; D016896:Treatment Outcome
chemical_list: D003879:Dermatologic Agents