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Query: UMLS:C0152030 (skin irritation)
 2,146 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

One reliable, controlled and convenient method of delivering parenteral estrogen replacement therapy is by means of a transdermal patch known as the Estraderm Transdermal System, which contains a 17-beta estradiol formulation. The primary side effect appears to be a localized skin irritation in about 15 percent of the women using this route. Most women find this irritation annoying but not enough to necessitate stopping therapy. Studies indicate that the patch provides amelioration of climacteric symptoms that is comparable to the oral estrogens. Preliminary research shows that parenteral estrogen is as effective as oral estrogen in decreasing the risk of osteoporosis. No adverse changes in lipid-lipoprotein levels have been found. A recent Swedish study found an increased relative risk of breast cancer with estradiol and with combined estrogen-progestin use for postmenopausal therapy. Thus, more research on the long-term hormonal replacement effects of the patch is indicated. One advantage of the transdermal delivery system is a first bypass of the liver, thus decreasing the possible risk of renin substrate elevation and the potential increase in blood pressure associated with oral estrogen therapy.
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PMID:Estrogen replacement therapy and the estraderm transdermal system. 234 64

Results of clinical studies have revealed that the transdermal therapeutic system of estrogen administration (Estraderm, Ciba Pharmaceutical Co., Summit, New Jersey) is both effective and well tolerated. Relief of hot flushes and vaginal atrophy has been shown to equal oral administration of conjugated equine estrogens and early experience suggests that the bone sparing effect is maintained. The patch has no effect on certain liver proteins; safety variables have shown no adverse biochemical changes. Moderate bleeding has occurred in some patients with an intact uterus but can be controlled by the addition of a progestogen. The incidence of endometrial hyperplasia and breast tenderness has been relatively low, and minor side effects (such as fluid retention) have been limited. Several investigators have evaluated skin irritation resulting from the systems. Some erythema has been reported but serious ulcerations or sloughing did not occur. A survey of patient attitudes comparing oral administration and transdermal systems indicated a preference for the transdermal method.
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PMID:Clinical experience with transdermal estradiol in the treatment of the climacteric. 254 95

The results of both single- and multicenter clinical studies have revealed that the transdermal therapeutic system of estrogen administration (Estraderm, CIBA Pharmaceutical Co., Summit, New Jersey) is both effective and well tolerated. In contrast to oral conjugated estrogens, the patch has no effect on certain liver proteins. Safety variables measured during one study showed no biochemical changes. Moderate bleeding has occurred in some patients with an intact uterus but can be controlled by the addition of a progestogen. The incidence of endometrial hyperplasia and breast tenderness has been relatively low, and minor side effects (such as fluid retention) have been limited. Several investigators have evaluated skin irritation resulting from the systems. Some erythema has been reported, but serious ulcerations or sloughing did not occur. A survey of patient attitudes comparing oral administration and transdermal systems indicated a preference for the transdermal method.
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PMID:Transdermal estradiol overall safety profile. 295 48

In this study sucrose laurate was formulated in hydrogels and investigated as a suitable transdermal penetration enhancer for oestradiol. Using rabbits as an animal model, the absolute bioavailability and the skin irritation were evaluated after single and multiple application. Three hydrogels containing 60 mg% oestradiol were evaluated: Oestrogel, and two hypromellose gels containing 5 and 15% sucrose laurate (w/w), respectively. No stability problem of the sucrose laurate was detected during a storage period of four months at 7 +/- 2 degrees C. After single application no significant difference (P < 0.05) was observed between the bioavailability parameters of Oestrogel and the 5% sucrose laurate gel. The values obtained for the 15% sucrose laurate gel were significantly higher than for the other gels. When applied on day 7 after a 6-day treatment, twice daily with the respective placebo gel, no significant difference was seen amongst the three formulations for any of the parameters evaluated. When the results after multiple application were compared with those after single application, a significant increase in oestradiol bioavailability was seen for the gel containing 30% ethanol and a significant decrease in oestradiol bioavailability was seen for the 5 and 15% sucrose laurate gels. Histological evaluation of the untreated and treated skin biopsies, showed a significantly higher incidence of infiltrate for all treated skin biopsies in comparison with the untreated ones. A significant increase in skinfold thickness was seen for the skin biopsies treated with gel containing 15% sucrose laurate. It can be concluded that sucrose laurate shows a potential as an absorption enhancer for percutaneous drug delivery.
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PMID:Sucrose laurate gels as a percutaneous delivery system for oestradiol in rabbits. 879 68

In the future, hormone replacement therapy (HRT) is likely to become of increasing importance, not only to control short-term climacteric symptoms, but also to protect postmenopausal women from the increasing risk of cardiovascular disease, osteoporosis and other conditions that accompany ovarian failure. This paper reviews the principles and practice associated with HRT, focusing on clinical experience with a new 7-day estrogen matrix patch (Climara). Results from two 11-week placebo-controlled studies, which compared the 7-day patch at two dose levels with 0.625-mg/day oral conjugated equine estrogen, found that both the 0.5- and 0.1-mg estradiol/day patches had a positive effect on climacteric symptoms. Tolerance was good and similar for both patches. Separate studies of skin irritation and adhesion revealed that the 7-day patch was well tolerated and that, although irritation was similar to that associated with Estraderm, adhesion was superior with the 7-day patch. Data on absorption of estradiol from different skin sites indicate that absorption is higher and more consistent from the buttock than from the abdomen, suggesting that choice of application site may require further investigation.
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PMID:Clinical experience with a 7-day estrogen patch: principles and practice. 979 34

An open-label, randomized, crossover study was conducted to assess the bioequivalence of two 7-day transdermal 17beta-estradiol delivery systems following application to the buttock in 42 postmenopausal women. The systems tested were a generic Estradiol Transdermal System (Mylan Pharmaceuticals, Inc.) and Climara (Berlex Laboratories, Inc.), the reference product. Each system was labeled to deliver 17beta-estradiol 0.1 mg/day and was applied for 7 days. Serial serum samples were assayed for estradiol, estrone, and estrone sulfate using validated assays. The bioequivalence confidence intervals for the ratio of log-transformed 17beta-estradiol Cmax values for the Estradiol Transdermal System and Climara were outside the interval of 0.80 to 1.25, indicating that the products were not bioequivalent. Application site reactions and skin irritation were more common with the Estradiol Transdermal System than with Climara. The odds of patch lifting or detachment were 6.95 times higher with the Estradiol Transdermal System than with Climara. Because these two transdermal delivery systems had been previously shown to be bioequivalent after application to the abdomen, the findings of this study suggest that bioequivalence at one anatomical site is not indicative of bioequivalence at another.
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PMID:An evaluation of bioequivalence of two 7-day 17beta-estradiol transdermal delivery systems by anatomical site. 1236 28