Spinosad at 0.9% in the treatment of scabies: Efficacy results from 2 multicenter, randomized, double-blind, vehicle-controlled studies.

BACKGROUND: Scabies is a contagious skin disease resulting from Sarcoptes scabiei infestation. There are no approved over-the-counter treatments, and approved prescription products have disadvantages, including potential resistance. Spinosad, an insecticide derived from fermentation of a soil actinobacterium, shows promise as a potential treatment agent. OBJECTIVE: Combined results from 2 controlled clinical studies were used to evaluate the efficacy of 0.9% spinosad topical suspension in the eradication of scabies. METHODS: Each study included index subjects (the youngest household members with active scabies) and up to 5 other members in each household. Subjects applied 0.9% spinosad or vehicle once. Primary efficacy was the percentage of index subjects with complete cure on day 28. Additional efficacy included clinical cure, microscopic cure, and lesion counts. RESULTS: Spinosad at 0.9% is not equivalent to vehicle in the percentage of index subjects achieving complete cure on day 28 (78.1% vs 39.6%, respectively; P < .0001; n = 206). Additional efficacy analyses confirmed the consistent treatment effect of 0.9% spinosad. No safety signals were observed. LIMITATIONS: The studies used small sample sizes to assess equivalency. CONCLUSIONS: Spinosad at 0.9% performed better than vehicle in the treatment of scabies in these studies of subjects of 4 years of age or older following 1 application of study drug.

Estrogens for the menopause.

There is no question that exogenous estrogens can relieve distressing menopausal symptoms such as hot flashes and atrophic vaginitis. Before prescribing them, however, a physician should establish that the need for hormone replacement is real and that the potential for harm is minimal.

Are women with urogenital atrophy symptomatic?

OBJECTIVE: The purpose of this study was to determine the degree of correlation between physical signs of genital atrophy and symptoms that are suggestive of atrophic vaginitis. STUDY DESIGN: Female volunteers (n = 135; mean age, 69 years) rated the presence and severity (rating, 0-3) of vaginal atrophy symptoms. The presence and severity of vaginal mucosal changes, which included vaginal pH (0-3), were recorded during a pelvic examination. A vaginal cytologic maturation value was performed. Symptoms, signs, pH, and maturation value were correlated by the Spearman rank test. RESULTS: Symptom scores were low (mean, 0.41; range, 0-2.6). Symptoms were only weakly correlated with physical findings (r = 0.14) and not with maturation value (r = 0.06) or age (r = -0.004). There was a moderate correlation between physical examination score and maturation value (r = -0.48). In women > or =65 years old, symptom score and physical examination score were correlated weakly (r = 0.25). Low pH correlated well with high maturation value (r = -0.52). Women who were undergoing estrogen therapy had higher symptoms scores (P =.0007) and maturation values (P =.0002) than women who were not undergoing therapy. CONCLUSION: Although urogenital atrophy occurs universally after menopause, most elderly women are minimally symptomatic. Those women on estrogen replacement therapy may be more symptomatic. Symptoms alone should not be used as a guide for the initiation of estrogen therapy.