Biomedical subjects

Sharon Levy

Publications and source records attributed to Sharon Levy.

26 records · Page 2Linked to original sources

PubMed2002

Evaluation of the efficacy and tolerability of 0.5% fluorouracil cream and 5% fluorouracil cream applied to each side of the face in patients with actinic keratosis.

BACKGROUND: A new 0.5% fluorouracil cream has been developed that provides an alternative to the more highly concentrated topical formulations of fluorouracil that are currently available. OBJECTIVE: This was a comparison of the tolerability and efficacy of the 0.5% and 5% fluorouracil creams in the treatment of actinic keratosis (AK). METHODS: During this single-blind, randomized study, patients with > or =6 AK lesions were treated for 4 weeks with the 0.5% (once daily) and 5% (twice daily) fluorouracil creams applied to opposite sides of the face. After the end of treatment, patients were followed for an additional 4 weeks. Efficacy variables included absolute and percent reductions in AK lesions from baseline and total clearance of AK lesions. A questionnaire was used to evaluate patients' treatment preferences. Tolerability was evaluated through continuous monitoring of adverse events. RESULTS: Treatment with 0.5% fluorouracil cream reduced the number of AK lesions from 11.3 at baseline to 2.5 at the end of the 4-week follow-up phase, compared with a reduction from 10.3 to 4.2 lesions after treatment with 5% fluorouracil cream. The reduction was significantly greater with the 0.5% cream compared with the 5% cream (P = 0.044). The 0.5% cream was as effective as the 5% cream in terms of the percent reduction in AK lesions from baseline (67% and 47%, respectively) and in achieving total clearance of AK lesions (both treatments, approximately 43% of patients). Both treatments were associated with similar degrees of investigator-rated irritation; however, patients preferred the 0.5% cream because they felt it was more tolerable (P = 0.003), easier to apply, and had a once-daily application schedule. Although all patients experienced facial irritation in association with both creams, fewer patients treated with the 0.5% cream reported symptoms of facial irritation. CONCLUSIONS: In this study, 0.5% fluorouracil cream once daily was at least as effective as 5% fluorouracil cream twice daily in terms of the percent reduction in AK lesions and total clearance of AK lesions; it was more effective than the 5% cream in reducing the absolute number of AK lesions from baseline. Patients preferred the 0.5% cream to the 5% cream.

Administration, Topical↗

PubMed2002

A randomized, parallel, vehicle-controlled comparison of two erythromycin/benzoyl peroxide preparations for acne vulgaris.

BACKGROUND: Topical erythromycin/benzoyl peroxide (EBP), marketed for acne treatment, must be compounded by a pharmacist and requires subsequent refrigeration, warranting the development of alternate formulations. OBJECTIVE: This trial compared the efficacy and tolerability of a single-use EBP combination package (EBP Pak) with those of its matching vehicle control (VC Pak) and the original, reconstituted formulation packaged in a jar (EBP Jar). The matching VC for the original formulation (VC Jar) was used to achieve study blinding. METHODS: In this double-blind, parallel-group, multicenter study, patients were randomly assigned to the 4 treatment arms. The primary efficacy evaluations were lesion reductions from baseline and treatment success (as defined by a Physician's Global Acne Severity score of 0 [clear] or 0.5 [sparse comedones with few or no inflammatory lesions]). Secondary evaluations were Physician's Global Acne Severity scores, facial-oiliness scores, and end-point patient evaluations of global improvement and treatment acceptability. Tolerability was based on the incidence and severity of adverse events. RESULTS: Three hundred twenty-seven patients (age range, 12-46 years) were randomly assigned to the 4 treatment groups (EBP Pak, 124; VC Pak, 42; EBP Jar. 121; VC Jar, 40). Mean percent reductions in total acne lesions, inflammatory acne lesions, and come-dones from baseline were significantly greater with EBP Pak than with VC Pak (P < or = 0.001 for the intent-to-treat patient population after 8 weeks). Statistical significance for all lesion parameters was demonstrated at week 2 (P < 0.05) and maintained throughout the study. At 8 weeks, a significantly greater proportion of patients demonstrated treatment success with the EBP Pak compared with VC Pak (28% vs 2%, respectively; P < 0.001). The EBP Pak was comparable to the EBP Jar in terms of reduction in acne lesions, Physician's Global Acne Severity scores, and end-of-treatment patient evaluations of global improvement. No serious drug-related adverse events were reported. CONCLUSIONS: Results of this 8-week trial demonstrate that the single-use combination package of EBP is well tolerated, effective, and comparable to the original formulation for the treatment of acne vulgaris in this selected patient population.

Acne Vulgaris↗

PubMed2002

Future patient care: tele-empowerment.

We explored the attitudes and responses of older people to telecare and home-based technologies. The perceptions of a small group of subjects who had no knowledge or experience of the use of telehealth equipment were compared with the experiences of a second small group who had used a video-link in a remote consultation with their general practitioner. Data were collected by engaging subjects in a semistructured interview in their own home. A questionnaire, which was developed following the analysis of the interview data, was also distributed to three client groups in Scotland. These groups were day hospital patients, residents of local authority sheltered housing schemes and residents of a private housing association. One hundred and ninety-nine questionnaires were returned (a 42% response rate), all from people aged 60 years and over. Analysis of the questionnaires suggested that the main demographic factors associated with positive attitudes to telecare were age, home ownership, dwelling type (sheltered housing or not) and household composition. The results suggest that an appropriate nurse-led telehealth service, which facilitates trust between clients, providers and the technology, could be the mechanism by which to encourage people to accept and use home-based systems.

Aged↗

PubMed2002

A novel 0.5% fluorouracil cream is minimally absorbed into the systemic circulation yet is as effective as 5% fluorouracil cream.

Recent in vitro and in vivo studies compared the absorption of a 0.5% fluorouracil cream with that of a 5% fluorouracil cream, following topical application to the skin. Both studies demonstrated that fluorouracil is minimally absorbed into the systemic circulation. Despite a one-tenth concentration difference between formulations, the cumulative amount of fluorouracil excreted in the urine of patients treated with the 0.5% cream was one fortieth that of patients treated with the 5% cream. Interestingly, higher percentages of fluorouracil were retained in the skin following application of the 0.5% cream compared with the 5% cream, suggesting that delivery of the 0.5% cream may be more targeted to the affected area. Other studies have demonstrated that the 0.5% cream is as effective as the 5% cream for the treatment of actinic keratoses (AKs) and has a more favorable tolerability profile. Therefore, this new 0.5% fluorouracil cream may be a safer, yet equally effective treatment alternative.

Administration, Topical↗

PubMed2002

Effective treatment of actinic keratosis with 0.5% fluorouracil cream for 1, 2, or 4 weeks.

New therapeutic options would benefit patients with actinic keratosis (AK), a precancerous condition that is a significant health concern. The efficacy and safety of a microsphere-based formulation of 0.5% fluorouracil cream were evaluated in a randomized, double-blind, multicenter, parallel-group study. Patients (N= 177) were randomized to receive 0.5% fluorouracil or vehicle once daily for 1, 2, or 4 weeks. Efficacy was assessed by lesion counts and clearance. Safety was evaluated by monitoring adverse events, including facial irritation. Significant improvements were seen from baseline to posttreatment follow-up in all efficacy variables for all fluorouracil regimens compared with vehicle. Patients treated for one week experienced significant improvements compared with vehicle, although efficacy increased with increasing treatment duration. Most patients experienced mild to moderate facial irritation of predictable onset and duration. Once-daily administration of 0.5% fluorouracil cream for 1, 2, or 4 weeks is safe and effective for the treatment of AKs.

Administration, Topical↗

PubMed2002

Randomized trial evaluating a new 0.5% fluorouracil formulation demonstrates efficacy after 1-, 2-, or 4-week treatment in patients with actinic keratosis.

The efficacy and safety of a new 0.5% fluorouracil topical cream were compared with vehicle control for the treatment of actinic keratosis (AK). Active treatment applied once daily for 1, 2, or 4 weeks was more effective than vehicle control in achieving reduction from baseline in lesion counts and lesion clearance. Active treatment also resulted in significantly better global assessments of overall improvement. Treatment was effective regardless of the number of baseline lesions. Although longer treatment duration correlated with greater efficacy, treatment for 1, 2, or 4 weeks was effective. This new microsphere-based fluorouracil formulation was generally well tolerated; adverse events were primarily limited to facial irritation that resolved quickly after treatment. This new treatment provides a safe alternative to the topical fluorouracil formulations currently available for the 1-, 2-, or 4-week treatment of AK.

Administration, Topical↗

PubMedDate not supplied

Perfusion of human term placentas with lipopolysaccharide did not affect the capacity of the fetal and maternal tissues to produce interleukin-10.

IL-10 is anti-inflammatory cytokine that is involved in the regulation of the pregnancy process. We examined the capacity of fetal and maternal placental tissues from human term placentas, to produce IL-10, in the presence and absence of LPS. The levels of IL-10 were examined (by ELISA and immunohistochemical staining) in the fetal and maternal tissues of human placentas after 10 hours of perfusion, in the presence or absence of lipopolysaccharide (LPS; 1 microg/k"g perfused tissue). We could detect IL-10 in amnion (A; 13.91+/-11.35 pg/ml) and chorion (CH; 7.85 +/- 6.38 pg/ml) tissue homogenates, and in the homogenates of three different sites of the placental tissue compartment (subchorionic placenta (SubCH); 7.39 +/- 4.39 pg/ml, mid-placenta (MidPL); 8.9 +/- 4.73 pg/ml and decidua (Decid); 16.48 + 11.86 pg/ml). Immunohistochemical studies showed that IL-10 was localized in the epithelial cells of the amnion, and in the fibroblasts and macrophages of the chorion. In the placenta and mid-placental sites, IL-10 is localized mainly in cytotrophoblasts and syncytotrophoblasts. The presence of LPS in the perfusion media of the placentas for 10 hours, did not significantly affect the capacity of the fetal and maternal tissues to produce IL-10. Thus, our results may indicate the involvement of the fetal compartment in the down-regulation of the cell-mediated response of the maternal compartment against the fetus, by producing IL-10 under physiological conditions. Infection/inflammation agents such as LPS did not affect the expression levels of IL-10 in the placenta.

Female↗

PubMedDate not supplied

Lipopolysaccharide induces the expression of interleukin-1alpha distinctly in different compartments of term and preterm human placentae.

The aim of the study was to investigate the stimulatory effect of lipopolysaccharide (LPS) on IL-lalpha production in different compartments of term and preterm placental tissues. Homogenates from amnion, chorion, and from fetal (subchorionic placental tissues, maternal decidua, and mid-placental tissue before and after perfusion of isolated placental cotyledons of 5 term placentas and 4 placentas obtained after preterm birth (28-34 W of gestation) were examined. Isolated placental cotyledons were dually perfused LPS (100 ng/kg perfused placental tissue) was perfused into the maternal side during 10 hours. Homogenates of the samples were examined by ELISA for IL-1alpha levels, and paraffin sections of the samples were stained by immunohistochemical staining, to characterize the cellular origin of placental IL-1alpha. Paired t test and ANOVA determined statistical significance. In the homogenates, there was a tendency towards higher IL-lalpha levels in all preterm placental compartments as compared to the term compartments before perfusion. A significant increase was observed only in the chorion compartment (p = 0.035). LPS had significantly increased IL-la levels only in the decidua compartment of term placentas as compared to other placental compartments (p = 0.0004), and had decreased IL-1alpha levels in the mid-placenta (p = 0.034). In preterm placentas, addition of LPS did not affect the expression levels of IL-1alpha in either fetal or maternal compartments as determined by ELISA and immunohistochemical staining. IL-la levels in the chorion compartment of preterm placenta were significantly higher as compared to term placenta. LPS affects placental tissues of term and preterm placentas differently. Also, in the term placentas, LPS affected the different compartments differently. Thus, IL-1alpha may have a key role (as a autocrine/paracrine factor) in the regulation of normal and pathological pregnancy and parturition.

Autocrine Communication↗