Registration Dossier
Registration Dossier
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EC number: 611-930-7 | CAS number: 60045-26-3
Endpoint summary
Administrative data
Description of key information
The objective of the study was to assess the safety of benzyl benzoate lotion and permethrin as topical treatments for scabies during pregnancy. The population studied comprised refugee and migrant women attending antenatal clinics on the Thai-Burmwese border between August 1993 and April 2006.
The study concluded that there was no evidence of adverse effects on pregnancy outcome due to topical application of 25% benzyl benzoate lotion or 4% permethrin.
Additional information
Women treated with either BBL (25%) or permethrin (4%) were identified from a manual search of antenatal records. Each case of scabies was matched with four scabies-free controls for gravidity, age, smoking status, malaria, period of treatment and gestational age at treatment. Conditional Poisson regression was used to estimate risk ratios for outcomes of pregnancy (proportion of abortions, congenital abnormalities, neonatal deaths, stillbirths and premature babies), mean birthweight and estimated median gestational age, for scabies and scabies-free women, independently for BBL and permethrin.
There were no statistically significant differences in pregnancy outcomes between women who were treated with either BBL (n = 444) compared with their matched controls (n = 1,776) or permethrin (n = 196) treated women and their matched controls (n = 784). Overall, only 10.9% (n = 66) of treatments were in the first trimester. Retreatment rates were higher with BBL 16.4%, than permethrin 9.7%, P = 0.038. Scabies was more common during cooler periods.
There was no evidence of adverse effects on pregnancy outcome due to topical 25% BBL or 4% permethrin
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