Comparative study to evaluate skin irritation and adhesion of Estradot and Climara in healthy postmenopausal women.
OBJECTIVE
To compare the local tolerability, adhesion and estradiol delivery of a 5-cm(2) transdermal patch (Estradot), Novartis Pharmaceuticals, Basel, Switzerland) and a 12.5-cm(2) patch (Climara, Berlex Laboratories, Wayne, NJ, USA).


METHODS
This was an open-label, randomized, intrapatient, comparative study. One hundred healthy postmenopausal women applied the 50 micro g/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.


RESULTS
The 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.


CONCLUSIONS
The 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.
Ibarra de Palacios
P
P
Novartis Pharma AG, Basel, Switzerland.
Schmidt
G
G
Sergejew
T
T
Quebe-Fehling
E
E
Lockhart
L
L
Krinsky
L
L
D000268:Adhesiveness; D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D018592:Cross-Over Studies; D004487:Edema / Q000139:chemically induced*; D004890:Erythema / Q000139:chemically induced*; D004958:Estradiol / Q000008:administration & dosage* / Q000009:adverse effects*; D015914:Estrogen Replacement Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D017698:Postmenopause; D011537:Pruritus / Q000139:chemically induced; D015203:Reproducibility of Results; D012871:Skin Diseases / Q000139:chemically induced*
D004958:Estradiol