Objective: To determine whether the Contact Allergen Replacement Database would improve clinical outcomes for patients with allergic contact dermatitis associated with topical skin care products by helping patients avoid known allergens. Design: This study was a randomized, single-blind, controlled trial. Setting: The study was conducted at the outpatient facilities at Mayo Clinic, Scottsdale, Ariz, and Rochester, Minn. Participants: Of the 29 patients enrolled, 21 completed the study. Intervention: All patients were randomly assigned to either a Contact Allergen Replacement Database group or a traditional therapy group. Patients in the database group received an individualized list of topical skin care products free of the antigens identified by the results of their individual patch tests. Otherwise, the 2 groups received identical therapy. Main Outcome Measures: To evaluate erythema, scale, and pruritus at 3-month follow-up, each variable was given a severity score from 0 to 3. A 1-point change was considered clinically notable. We also evaluated total physician-patient counseling time and patient satisfaction. Results: We found no statistically significant differences (P>.05) between the 2 treatment groups on measures of disease activity and counseling time. However, 91% of the database group reported the allergen-free product list to be either somewhat helpful or very helpful in managing contact dermatitis. All the patients without access to the database said it would have been helpful. Conclusions: Although this small study, with its limited follow-up, did not yield objective evidence supporting the use of the Contact Allergen Replacement Database, the database-generated product lists were favorably received by patients. We anticipate an expanded clinical role for this database as an Internet-based resource.
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