People use OTC hydrocortisone cream in safe and appropriate amounts

(2005-06-12)

Adults and children generally apply the product that is commonly used to treat these conditions - over-the-counter hydrocortisone cream (HC) - in safe and appropriate amounts.

Charles N. Ellis, M.D., of the University of Michigan Health System said he was pleasantly surprised by the number of study participants who complied with the usage guidelines. Ellis is the lead author of the study, which appears early in the online edition of the Journal of the American Academy of Dermatology.

"The people in the study reported that they're following the label in large part," says Ellis, professor and associate chair of dermatology in the U-M Medical School, and chief of the Dermatology Service at the Veterans Affairs Ann Arbor Healthcare System. "Not many of them have used it beyond the suggested amount of time, and not many used it more often than recommended."

"Our findings suggest that people who use over-the-counter hydrocortisone cream generally do so in a way that is likely to be safe," he says.

Adults were found to be compliant with the instructions about three-quarters of the time, and they reported following the recommendations for treating children about as often. The most common way in which people were not compliant with directed uses was in using the creams to treat cuts. It also was used to treat acne, athlete's foot, arthritis and jock itch, against the recommendations on the label. HC is not effective in treating these conditions.

The 2,000 study participants were asked in phone interviews if they had used over-the-counter hydrocortisone products such as Cortaid, Cortizone 10 or other similar products in the past six months. Those who had used OTC hydrocortisone products were asked questions about their patterns of use. They answered these questions without being able to refer to the product label.

Respondents also were asked if they had any children younger than 18 in the house who had used HC; if so, they were asked about the use by the youngest child in the past six months.

Respondents who had used hydrocortisone or whose children had used it were asked what conditions they had treated with the cream and questions about their usage patterns, including the frequency and duration of use. They also were asked if they had discussed with a doctor their own usage of HC and/or their use of it on the youngest child in the household.

In all, 396 (20 percent) of the adults in the study reported using over-the-counter HC in the previous six months. The most common conditions they treated with the creams were rashes, insect bites and itchy skin.

Researchers found that when adults were using HC, they did so an average of twice a day, and 98 percent of them used it four or fewer times a day, which complies with directions for use. That means only 2 percent of adults reported using HC more times in a day than recommended. In all, when factors such as the type of use and the duration of use were factored in, almost three-quarters - 73 percent - of adults in the study were compliant with the instructions on the label. One-third of the adult respondents had discussed the use of topical HC with a doctor. The compliance level rose to 89 percent when the results were recalculated with the assumption that the doctor had allowed for wider uses and treatment regimens.

In children, HC tended to be used primarily for insect bites, rashes, eczema and itchy skin. Of the 2,000 households, one-third had a child younger than 18 living at home and a quarter of those reported treating a child with over-the-counter HC in the previous six months.

The frequency of use was more than the recommended maximum of four times a day in only 3 percent of cases, and only 6 percent reported using it for longer than the recommended maximum of seven days. More than half (55 percent) of these households reported talking to a doctor at some time about their child's use of over-the-counter HC.

In all, given the duration and frequency of use, the type of condition treated, and the age of the child, 72 percent of the use on children followed the recommended usage guidelines. When the figure was recalculated to assume that the physicians who were consulted had allowed for wider uses and treatment regimens, the compliance level rose to 89 percent.

In addition to Ellis, the other authors on the paper were Michelle D. Ertischek, Janine L. Pillitteri, Ph.D., and Saul Shiffman, Ph.D. of Pinney Associates; and Theodore K. Kyle, R.Ph., and Steven L. Burton, M.B.A., of GlaxoSmithKline Consumer Healthcare.

The study was supported by GlaxoSmithKline Consumer Healthcare. Ellis, Pillitteri, Shiffman and Ertischek serve as consultants to GlaxoSmithKline Consumer Healthcare. Ellis also serves as a consultant to other manufacturers of topical corticosteroids. GSK does not sell a topical HC but does sell a low-potency prescription-strength topical corticosteroid (Aclovate).

Reference: Journal of the American Academy of Dermatology

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