Evaluation of skin tolerability in patients on a 7-day regimen of a new matrix transdermal estradiol delivery system: An open-label study

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Data
1997-07-01
Autores
Baracat, Edmund Chada [UNIFESP]
Yamada, Sérgio [UNIFESP]
Haidar, Mauro Abi [UNIFESP]
De Lima, Geraldo Rodrigues [UNIFESP]
Peloso, Ulisses
Benedictis, Eliana
Casoy, Julio
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The incidence and severity of local skin reactions, as well as the impact on the local bacteriologic profile, in a 7-day regimen of a matrix transdermal estradiol delivery system compared with placebo (a piece of adhesive tape for sensitive skin of approximately the same shape and area) were assessed in healthy postmenopausal Brazilian women in an open-label study. the matrix estradiol and placebo patches were applied to different sites of the abdominal area, worn for 7 consecutive days, and then replaced according to an established rotation schedule, until 5 weeks of treatment were completed. the rotation schedule was adopted to provide an assessment of skin reaction as related to (1) interval between two consecutive placements at the same application site; (2) number of repetitions; and (3) abdominal region (upper, middle, and lower). A skin reaction score was obtained at each site before the application of each patch, 80 minutes after patch removal, and 7 days after patch removal. Skin swabs were obtained for bacteriologic cultures immediately before patch application and immediately after patch removal. Twenty-seven women were enrolled and completed the study; 270 skin observations were made with the estradiol patch and 162 with placebo. Skin reactions 30 minutes after patch removal included erythema (23.7%), erythema with induration (4.1%), and erythema with induration and vesicles (1.1%). Seven days after patch removal, skin reactions had decreased to erythema (2.2%) and erythema with induration (0.4%); no erythema with induration and vesicles was seen. This reduction in incidence and severity was statistically significant. Thirty minutes after placebo removal, 2.5% of skin observations detected erythema; no erythema was observed 7 days later. No other severe reactions were observed, and no clinically significant alteration in skin flora was detected. the results of this study indicate an acceptable level of local skin responses to this 7-day estradiol patch application. in addition, 96.3% of patients rated the estradiol patch as good or very good in its acceptability.
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Current Therapeutic Research-clinical and Experimental. New York: Excerpta Medica Inc, v. 58, n. 7, p. 417-427, 1997.
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