Comparative study to evaluate skin irritation and adhesion of Estradot^®and Climara^®in healthy postmenopausal women

Abstract

Objectives To compare the local tolerability, adhesion and estradiol delivery of a 5-cm 2 transdermal patch (Estradot Ò , Novartis Pharmaceuticals, Basel, Switzerland) and a 12.5-cm 2 patch (Climara Ò , Berlex Laboratories, Wayne, NJ, USA). MethodsThis was an open-label, randomized, intrapatient, comparative study. One hundred healthy postmenopausal women applied the 50 mg/day 5-cm 2 patch and the 12.5-cm 2 patch concurrently for 7 days; safety and tolerability were assessed. Twelve women continued to apply the 5-cm 2 and 12.5-cm 2 patches separately for 7 days in a two-way cross-over study, to investigate the reproducibility of estradiol delivery. ResultsThe proportion of subjects with a clinically significant erythema score was higher with the 12.5-cm 2 patch. The 5-cm 2 patch had a significantly lower incidence of very slight erythema than the larger patch (21.4% vs. 32.3%; p = 0.0028). Overall erythema scores were 0.22 and 0.41, respectively. More 5-cm 2 patches had > 90% adherence than the 12.5-cm 2 patches (87.5% vs. 82.0%, not significant) and fewer became detached (0.5% vs. 3.0%). Both the patches showed reproducible delivery of estradiol. ConclusionThe 5-cm 2 patch was associated with less skin irritation and better adherence than the 12.5-cm 2 patch, although the majority of the differences were not significant. The 5-cm 2 patch was well tolerated and showed reproducible estradiol delivery, as did the 12.5-cm 2 patch.

The effects of skin-to-skin contact, application site washing, and sunscreen use on the pharmacokinetics of estradiol from a metered-dose transdermal spray

“…12,13 However, some estradiol patches can cause local skin irritation, including erythema, itching, discomfort, edema, vesicular rash, induration, and residual pigmentation in as many as 20% of participants. 14,15 Estradiol is also available in transdermal gel and emulsion formulations, but the large body surface area over which some products must be applied may make accurate dosing difficult and cumbersome. 16,17 An estradiol metered-dose transdermal spray (Evamist estradiol transdermal spray) has been developed that has been shown to provide accurate, reproducible systemic delivery of estradiol doses by administration of a rapidly drying solution to a small area of intact skin.…”

Transdermal Spray in Hormone Delivery

“…Transdermal 17 β-estradiol (E2) delivery simulates closely the circulating profiles of E2, estrone, and estrone sulfate normally observed in follicular phase premenopausal women than do oral systems [24,25], in addition problems occurred with patches E2 transdermal spray has been evaluated [24,26]. According to a randomized controlled clinical trial done by Buster et al [24], transdermal E2 spray in women with postmenopausal vasomotor symptoms supports the efficacy and safety of the first transdermal E2 spray approved in the United States for the treatment of moderate-to severe vasomotor symptoms in healthy menopausal women [24].…”

Clinical efficacy of biocellulose wound dressing containing silk sericin and polyhexamethylene biguanide for split-thickness skin graft donor sites

“…These results conformed to those of Ibarra de Palacios et al They investigated the skin irritation potential of a 12.5 cm 2 estradiol transdermal patch (Climara ® , USA) in 99 healthy postmenopausal women. The safety results claimed that 3.0% had moderate erythema, 1.0% severe erythema, 1.0% mild edema, and 34.3% papules [185].…”