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Biomedical subjects

Richard Weinstein

Publications and source records attributed to Richard Weinstein.

5 recordsLinked to original sources

Long-term efficacy and safety of tretinoin emollient cream 0.05% in the treatment of photodamaged facial skin: a two-year, randomized, placebo-controlled trial.

BACKGROUND: Long-term (>1 year) placebo-controlled studies of tretinoin in the treatment of photodamaged skin have not been conducted. Recently, we conducted a 2-year placebo-controlled study of tretinoin emollient cream 0.05%, including histopathologic assessment of safety and analysis of markers of collagen deposition. OBJECTIVE: The objective of the study was to determine the long-term safety and efficacy of tretinoin emollient cream 0.05% in the treatment of moderate to severe facial photodamage. METHODS: A total of 204 subjects were treated with tretinoin or placebo (vehicle emollient cream) applied to the entire face once a day for up to 2 years. Clinical and histologic effects were assessed at regularly scheduled clinic visits. RESULTS: Treatment with tretinoin resulted in significantly greater improvement relative to placebo in clinical signs of photodamage (fine and coarse wrinkling, mottled hyperpigmentation, lentigines, and sallowness), overall photodamage severity, and investigator's global assessment of clinical response (p<0.05). Histologic evaluation showed no increase in keratinocytic or melanocytic atypia, dermal elastosis, or untoward effects on stratum corneum following treatment with tretinoin compared with placebo. Immunohistochemistry studies, conducted at three study centers, showed a significant increase relative to placebo in facial procollagen 1C terminal, a marker for procollagen synthesis, at month 12 (p=0.0074). CONCLUSION: Long-term treatment with tretinoin emollient cream 0.05% is safe and effective in subjects with moderate to severe facial photodamage.

Administration, Topical↗

A multicenter, open-label, randomized, two-period crossover trial comparing glycemic control, satisfaction, and preference achieved with a 31 gauge x 6 mm needle versus a 29 gauge x 12.7 mm needle in obese patients with diabetes mellitus.

BACKGROUND: Optimal needle length for subcutaneous insulin injection may differ for obese and nonobese patients, which could affect management of diabetes mellitus (DM). OBJECTIVE: The aim of this study was to determine whether 31 gauge (G) x 6 mm (shorter) needles are appropriate alternatives to 29 G x 12.7 mm (longer) needles in obese patients with DM. METHODS: A multicenter, open-label, randomized, 2-period crossover trial was conducted in insulin-treated patients with type 1 or 2 DM with body mass index >or=30 kg/m(2) and glycosylated hemoglobin A(1c) (HbA(1c)) concentration <or=10%. All patients used the same injection device and were randomized to receive 12 weeks of therapy with 1 injection site (thigh or abdomen) and 1 of the 2 needle lengths. Patients used the same injection site but the alternate needle during the second 12-week period. RESULTS: Sixty-two patients (31 men, 31 women; mean [SD] age, 50.5 [10.6] years; age range, 20-73 years) received treatment. Fifty-six patients completed all 24 weeks of treatment. No differences in glycemic control were found. Double-blind assessments of pain scores and leakage measurements, and results from the World Health Organization Diabetes Treatment Satisfaction Questionnaire and most sections of the Insulin Treatment Satisfaction Questionnaire (ITSQ), indicated no differences. However, patients indicated greater satisfaction with the shorter needle on the ITSQ (P < 0.001). The most common adverse event was injection-site bruising (51% [30/59] for the longer needle vs 34% [21/61] for the shorter needle; P = NS). Eighty-nine percent of patients (49/55) preferred the shorter needle (P < 0.001), and 76% (42/55) had a strong, very strong, or extremely strong preference for it. CONCLUSIONS: In obese patients, use of 31 G x 6 mm and 29 G x 12.7 mm needles produced comparable HbA(1c) values, double-blind pain and leakage scores, convenience, and ease of use. However, patients preferred the shorter needle.

Adult↗

A continuous glucose sensor based on wired enzyme technology -- results from a 3-day trial in patients with type 1 diabetes.

Wired Enzyme (Therasense, Alameda, CA) sensing technology for continuous measurement of in vivo glucose concentrations offers the benefits of (1). excellent sensor stability, (2). reduced susceptibility to variations of in vivo oxygen concentration, and (3). minimized response to common electroactive interferents. This study describes the response of 48 sensors (25 in the upper arm, 23 in the abdomen) implanted for 3 days in patients with Type 1 diabetes. Prospective calibration was performed using capillary blood; results were compared with venous plasma glucose values obtained at 15-min intervals. Ninety-eight percent of readings fell in the clinically accurate Clarke error grid zone A or clinically acceptable zone B. Choice of the site of the implanted sensor (upper arm vs. abdomen) or the capillary blood calibration site (arm vs. finger) did not affect system accuracy.

Abdomen↗

Comparison of insulin aspart with buffered regular insulin and insulin lispro in continuous subcutaneous insulin infusion: a randomized study in type 1 diabetes.

OBJECTIVE: To compare the safety and efficacy of insulin aspart (IAsp), buffered regular insulin (BR), and insulin lispro administered by continuous subcutaneous insulin infusion (CSII) in patients with type 1 diabetes. RESEARCH DESIGN AND METHODS: After completing a 4-week run-in period with BR, 146 adult patients with type 1 diabetes (with pretrial CSII experience) were randomly assigned (2:2:1) to CSII treatment with IAsp, BR, or lispro for 16 weeks in a multicenter, open-label, randomized, parallel-group study. Bolus insulin doses were administered 30 min before meals (BR) or immediately before meals (IAsp or lispro). RESULTS: Treatment groups had similar baseline HbA(1c) (7.3% +/- 0.7 for IAsp, 7.5% +/- 0.8 for BR, and 7.3% +/- 0.7 for lispro). After 16 weeks of treatment, HbA1c values were relatively unchanged from baseline, and the mean changes in baseline HbA1c values were not significantly different between the three groups (0.00 +/- 0.51, 0.15 +/- 0.63, and 0.18 +/- 0.84 for the IAsp, BR, and lispro groups, respectively). The rates of hypoglycemic episodes (blood glucose <50 mg/dl) per patient per month were similar (3.7, 4.8, and 4.4 for the IAsp, BR, and lispro groups, respectively). Clogs/blockages in pumps or infusion sets were infrequent; most subjects (76, 83, and 75% in the IAsp, BR, and lispro groups, respectively) had < or = 1 clog or blockage per 4 weeks during the trial. CONCLUSIONS: Insulin aspart in CSII was as efficacious and well tolerated as BR and lispro and is a suitable insulin for continuous subcutaneous insulin infusion using external pumps.

Adult↗