Tolerance profile of a sterile moisturizer and moisturizing cleanser in irritated and sensitive skin.
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.
Vie
K
K
Pierre-Fabre Research Institute, Toulouse, France.
Pons-Guiraud
A
A
Dupuy
P
P
Maibach
H
H
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
D003358:Cosmetics; D004643:Emollients; D005079:Excipients; D010476:Perfume; D011310:Preservatives, Pharmaceutical; D012915:Soaps