Abstract：
OBJECTIVES:To examine the potential of a new matrix system developed for estradiol delivery to cause microbial proliferation under the occluded site or to cause acute phototoxicity reactions. METHODS:Twenty healthy post-menopausal women participated in a microbial proliferation study and 11 in a phototoxicity study. Both studies were single centre, single blind and placebo controlled. Microbial proliferation was assessed by quantitative counts of the total aerobic bacterial population and of eight individual species before patch application and after removal following a 4 day application period on the abdomen. Acute phototoxicity potential was assessed following an 8 h application period on the abdomen by irradiating the application site after patch removal with ultra violet A radiation and visible light and evaluating the sites for up to 48 h post irradiation. Non-irradiated active and placebo patches on the other side of the abdomen served as controls. RESULTS:Total aerobic bacterial populations both before and after the matrix patch application period were low as expected for dry skin. Separate counts of microbial species were also low and did not change in any meaningful or consistent manner after patch application. In the phototoxicity study, mild erythema was observed in some patients at 0, 0.5 and 24 h post patch removal with no differences between irradiated and non-irradiated sites. CONCLUSIONS:These two studies demonstrate that a new matrix patch developed for estradiol delivery does not promote microbial proliferation under the occluded patch site or cause acute phototoxicity following removal.
journal_name
Maturitasjournal_title
Maturitasauthors
Mulberry GK,Della-Cioppa G,Monza G,Harper RA,Oelrich DMdoi
10.1016/s0378-5122(96)01062-6subject
Has Abstractpub_date
1996-11-01 00:00:00pages
223-9issue
3eissn
0378-5122issn
1873-4111pii
S0378512296010626journal_volume
25pub_type
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