title: Tolerance profile of a sterile moisturizer and moisturizing cleanser in irritated and sensitive skin.
abstract: BACKGROUND
  This study evaluates the tolerance of preservative free sterile cleanser and sterile moisturizer in irritated and sensitive face skin.
  
  
  METHODS
  An exploratory, open-label study using the cleanser and the moisturizer in combination was performed with 98 patients with a documented history of allergic contact dermatitis. The 2 products could each be used once or twice daily for 28 days. The assessment parameters at baseline and end of treatment (day 28) included the intensity of erythema, dryness/scaling by the investigator and subjective signs (burning, pruritus and stinging), according to a defined 4-point scale (absent to severe). In addition, a global assessment of the change from baseline and the overall tolerance of the products were performed by the investigator at the end of treatment.
  
  
  RESULTS
  Ninety-four patients were included for the efficacy analysis and 96 patients for the safety analysis. At baseline, a majority of patients expressed some degree of erythema (63%), and dryness/scaling (56%). Fewer patients experienced subjective signs at baseline (44%). At the end of treatment, the results showed a statistically significant improvement of all the objective signs of irritated skin (P = .0001, Mac Nemar test), as well as the subjective signs of sensitive skin (P < 0.02). This was confirmed by the overall investigator assessment, showing an excellent or good response in 90% of the patients. In the safety analysis, 1 patient developed contact allergy to 1 ingredient of the test products (carbomer), and 3 patients exacerbated their dermatitis.
  
  
  CONCLUSIONS
  Taken together, these results suggest that adequately formulated cosmetics might reduce both irritated and sensitive skin, with clinical improvement of dryness, erythema and stinging.
authors.affiliation: Pierre-Fabre Research Institute, Toulouse, France.
authors.forename: K
authors.initials: K
authors.lastname: Vie
authors.forename: A
authors.initials: A
authors.lastname: Pons-Guiraud
authors.forename: P
authors.initials: P
authors.lastname: Dupuy
authors.forename: H
authors.initials: H
authors.lastname: Maibach
mesh_terms: D000328:Adult; D002626:Chemistry, Pharmaceutical; D003358:Cosmetics / Q000009:adverse effects*; D017449:Dermatitis, Allergic Contact / Q000145:classification / Q000209:etiology* / Q000473:pathology / Q000517:prevention & control*; D004643:Emollients / Q000009:adverse effects* / Q000737:chemistry*; D005079:Excipients / Q000009:adverse effects*; D005148:Facial Dermatoses / Q000139:chemically induced* / Q000145:classification* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D010476:Perfume / Q000009:adverse effects*; D010865:Pilot Projects; D011310:Preservatives, Pharmaceutical / Q000009:adverse effects*; D012449:Safety; D012720:Severity of Illness Index; D012915:Soaps / Q000009:adverse effects* / Q000737:chemistry*; D013242:Sterilization
chemical_list: D003358:Cosmetics; D004643:Emollients; D005079:Excipients; D010476:Perfume; D011310:Preservatives, Pharmaceutical; D012915:Soaps