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New treatments for head lice are needed. In this pair of randomized, controlled trials involving 765 patients, a single application of topical ivermectin had an efficacy of 94.9% on day 2 and 73.8% on day 15. Infestations of head lice ( Pediculus humanus capitis ) lead to social disruption by stigmatizing infested children and causing parental anxiety, loss of income because of the need to care for the child at home, and absenteeism from school or day care. 1 , 2 The first-line pediculosis treatments, permethrin and pyrethrins, belong to a chemical class to which there is now increasing resistance. 3 The established second-line treatments, lindane and malathion, have limitations related to safety and concerns about flammability and unpleasant odor. 4 Investigations of benzyl alcohol and spinosad, both recently approved by the Food and Drug Administration (FDA) for the treatment . . .

There are limited treatments for head lice. In this multicenter, cluster-randomized trial of 812 patients in 376 households, oral ivermectin was found to be superior to topical malathion lotion in eradicating head-lice infestation. In this trial of 812 patients in 376 households, oral ivermectin was found to be superior to topical malathion lotion in eradicating head-lice infestation. Head lice are universal human parasites, affecting over 100 million people worldwide each year. In the developed world, children 3 to 11 years of age are most likely to be affected. 1 Since the withdrawal in 2007 of the Cochrane review of head-lice treatments, 2 the only review available is a systematic review 3 published in 1995; it concluded that sufficient evidence of efficacy existed only for the pyrethroid insecticide permethrin (1% formulation), which had a cure rate with a lower 95% confidence limit of more than 90%. However, because of emerging pyrethroid resistance, malathion (0.5% formulation), an organophosphate insecticide, is now widely . . .

Background Head lice infestation is a common public health problem that is most prevalent in primary school children throughout the world, especially in developing countries including different parts of Iran. This study aimed to determine the prevalence and risk factors associated with head lice infestation and pediculicidal effect of 1% permethrin shampoo in primary schools girls of Bashagard County, one of the low socioeconomic areas in southeast of Iran. Methods In this interventional study six villages with similar demographical situations were selected and randomly assigned into intervention and control areas. In each area 150 girl students aged 7–12 years were selected randomly and screened for head lice infestation by visual scalp examination. In intervention area, treatment efficacy of 1% permethrin shampoo was evaluated via re-examination for infestation after one, two, and three weeks. Pre-tested structured questionnaire was used to collect data on socio-demographic and associated factors of head lice infestation. Results The prevalence of head lice infestation was 67.3%. There was significant association between head lice infestation and school grade, family size, parents’ literacy, bathing facilities, frequency of hair washing, and use of shared articles ( p  < 0.05). The effectiveness of 1% permethrin shampoo for head lice treatment was 29.2, 68.9, and 90.3% after the first, second, and third weeks, respectively. Conclusion The head lice infestation is a health problem in primary school girls of Bashagard County. Improvement of socioeconomic status and providing appropriate educational programs about head lice risk factors and prevention can be effective for reduction of infestation in this area. Trial registration This trial has been registered and approved by Hormozgan University of Medical Sciences ethical committee (Trial No.764). Trial registration date: March 17 2014.

Pediculosis capitis occurs worldwide. Children in the age group of 5–13 years are the ordinary victims. Population-based studies show that the prevalence of pediculosis is 1.6–13.4% in various regions of Iran. In this observer-blinded trial, we conducted a study to evaluate the comparative efficacy and safety of permethrin 1% and lindane 1% shampoos and dimeticone 4% lotion to cure head lice infestation in children aged 7–13 years in female primary schools in Ahvaz City, Iran. Children with head lice were randomized to receive each treatment. Two applications of permethrin 1% or dimeticone 4% were done, 1 week apart. However, lindane 1% was used just once for treatment cases. Data analysis was done using SPSS software. Recovery differences between the groups were tested using the chi-squared test. Four hundred forty-four louse-infested schoolgirls were randomly treated with them. Permethrin, lindane, dimeticone, and placebo produced the recovery rates 56.8, 31.5, 51.4, and 10.8% on day 2 post-treatment, respectively. Cure rates were in the permethrin group on days 8 and 15, respectively, 69.4 and 90.1%. The success rates were in the lindane group on days 8 and 15, respectively, 73 and 86.5%. The success rates were in the dimeticone group on days 8 and 15, respectively, 60.4 and 94.6%. It is recommended dimeticone lotion (4%) as a very effective and safe pediculicide for pediculosis control. With proper application, dimethicone can rapidly cure head lice infestation with minimal reinfestation.

Background Head lice infestation (Pediculosis) is one of the most important health challenges particularly in primary school-aged children. It is often present among 6–11-year-old students in various tropical and temperate regions of the world. The aim of this study was to examine epidemiologic indices and comparative analysis of two pyrethroid-based and one non-chemical pediculicide products on head lice treatment of primary school girls in a rural setting of Fars province, south Iran, as part of a randomized controlled assessor blind trial. Methods Before treatment, infested students were screened using plastic detection combs to find live head lice. Three independent parallel groups, each with about 25 participants (#77) were eventually twice with a week apart treated with either 1% permethrin, 0.2% parasidose (d-phenothrin) or 4% dimeticone lotion preparations. In each case, a questionnaire form was completed on epidemiologic factors. Data were registered after a fortnight from primary scalp treatment and re-inspection on days 2, 6, 9 and 14. Data analyses were performed using Chi-square test with a P -value < 0.05 being taken as statistically significant. Results From 3728 inspected students, 87 (2.33%) girls were infested with head lice, Pediculus humanus capitis De Geer, 1778. Ten students dropped out pertaining to exclusion criteria. No significant correlation was found between head lice infestation level and hair length, hair style, itching, nationality, age, settlement site and baths; but there was a significant relationship between age and hair style ( P  = 0.027). The efficacy values on each of the above re-inspection days from each of the three treatments were 81, 74, 70 and 63% for permethrin; 83, 92, 100 and 100% for dimeticone; and 96, 88, 96 and 92% for d-phenothrin; respectively. A quartile difference in efficacy of permethrin relative to dimeticone on day 14 represented the scale of head lice resistance to permethrin treatment. There were significant statistical differences in case re-inspection days 9 ( P  = 0.008) and 14 ( P  = 0.003) post treatment. Only two dropout cases, one non-compliant and the other lost before the second-week treatment, from permethrin trial were observed following two applications a week apart. Conclusions Dimeticone lotion had the fullest efficacy (100%) among all treatments. This high cure rate was attributed to the low level of infestation and the extent of patients’ involvement. Parasidose swiftly ameliorated the infested cases by the second day since initial treatment. Female third grade students were the most infested cohort. Trial registration Current Controlled Trials- IRCT2016041627408N1 , Dated: 21-08-2017.

Due to increased resistance and safety concerns with insecticide-based pediculicides, there is growing demand for head lice treatments with a physical mode of action. Certain mineral oils kill lice by blocking spiracles or by disrupting the epicuticular wax layer. The present study was performed to evaluate efficacy and safety of a mineral oil-based shampoo. This randomized, controlled, investigator-blinded, monocentric study (EudraCT registration no. 2014-002918-23) was performed from October 2014-June 2015 in Germany. A mineral oil shampoo (Mosquito® Med Läuse Shampoo 10 in Germany, Paranix or Silcap shampoo elsewhere), registered as medical device, was compared to a conventional, locally reimbursed, pyrethroid-based pediculicide (Goldgeist® Forte solution). In total, 107 patients (>1 year) with confirmed head lice infestation were included (test arm: n = 53; control arm: n = 54). All subjects received two applications of either test or control product at day 0 and day 7, according to the instructions for use. Efficacy and safety was evaluated directly, 1h and 24h after first application, before and after second treatment, and at day 10. The main objective was demonstrating a cure rate for the test product, being superior to 70% at day 10. Cure rates at day 10 (corrected for re-infestation) for the test product (96.1%) and control (94%) significantly exceeded the pre-defined target (70%) (p < 0.001, 2-sided, 1-sample, chi-square test) with confirmed non-inferiority for the test product. Over all visits, cure rates were consistently higher for the test product, whereas more initially-cured subjects remained lice-free until end of study (78%; control: 60%). Both products were safe and well tolerated, offering good esthetical effects. This study showed that substance-based medical devices (including the tested mineral oil shampoo) can be safe and effective alternatives for insecticide-based pediculicides, with less risk for development of resistance because of the physical mode of action. German Clinical Trials Register (DRKS) DRKS00009753 and EudraCT database 2014-002918-23.

Background Increasing resistance of head lice against neurotoxic agents and safety concerns have led to the search for treatment alternatives. Dimeticones with a physical mode of action are safe, and bear a reduced risk for the development of resistance. Methods We performed in vitro bioassays to assess pediculicidal and ovicidal activities of a new dimeticone-based product, and a randomized controlled clinical trial to assess efficacy, following 10 min application. Of 153 individuals screened, 100 participants with active head louse infestations were randomly assigned to treatment with either a dimeticone-based test product, or a 0.5% permethrin-based reference product (50 participants per group). Participants received two topical applications of either the test (10 min) or reference products (45 min) at days 0 and 7 or 8. Outcome measures included the efficacies of treatment and their safety, as well as global and local tolerability at baseline, and days 1, 7, and 10. Results After 10 min exposure, all lice treated with the dimeticone test product were classified as non-viable in the in vitro assay. Ovicidal activity after treatment of eggs with the dimeticone test product was 96.8%. In the clinical trial, 96 patients completed all study visits. In the full analysis set (FAS) population, on day 1 after one application, 98% of patients were cured in the test group, as compared to 84% cured in the reference group. All participants in both groups were free of head lice on day 10, following two applications (100% cure rate). In total, 42 adverse events (AEs) in 23 patients of both treatment groups were recorded, with the majority of AEs classified as mild. Conclusions We have shown a high level of pediculicidal and ovicidal activity, and clinical efficacy and safety, of a brief application of a new dimeticone-based product. The short application time and reduced risk for the development of resistance are key drivers for improved patients’ compliance. Trial registration EU Clinical Trials Register EudraCT  2016–004635-20 . Registered 14 November 2016.

Interest in developing physically active pediculicides has identified new active substances. The objective was to evaluate a new treatment for clinical efficacy. We describe the selection of 1,2-octanediol as a potential pediculicide. Clinical studies were community based. The main outcome measure was no live lice, after two treatments, with follow up visits over 14 days. Study 1 was a proof of concept with 18/20 (90%) participants cured. Study 2 was a multicentre, parallel, randomised, observer-blind study (520 participants) that compared 0.5% malathion liquid with 1,2-octanediol lotion (20% alcohol) applied 2-2.5 hours or 8 hours/overnight. 1,2-octanediol lotion was significantly (p<0.0005) more effective with success for 124/175 (70.9%) RR = 1.50 (97.5% CI, 1.22 to 1.85) for 2-2.5 hours, and 153/174 (87.9%) RR = 1.86 (97.5% CI, 1.54 to 2.26) for 8 hours/overnight compared with 81/171 (47.4%) for malathion. Study 3, a two centre, parallel, randomised, observer-blind study (121 participants), compared 1,2-octanediol lotion, 2-2.5 hours with 1,2-octanediol alcohol free mousse applied for 2-2.5 hours or 8 hours/overnight. The mousse applied for 8 hours/overnight cured 31/40 (77.5%), compared with 24/40 (60.0%) for lotion (RR = 1.29, 95% CI, 0.95 to 1.75; NNT = 5.7) but mousse applied for 2-2.5 hours 17/41 (41.5%) was less effective than lotion (RR = 0.69, 95% CI, 0.44 to 1.08). Adverse events were more common using 1,2-octanediol lotion at both 2-2.5 hours (12.0%, p = 0.001) and 8 hours/overnight (14.9%, p<0.0005), compared with 0.5% malathion (2.3%). Similar reactions were more frequent (p<0.045) using lotion compared with mousse. 1,2-octanediol was found to eliminate head louse infestation. It is believed to disrupt the insect's cuticular lipid, resulting in dehydration. The alcohol free mousse is more acceptable exhibiting significantly fewer adverse reactions. Controlled-Trials.com ISRCTN66611560, ISRCTN91870666, ISRCTN28722846.

Objective To evaluate the efficacy and safety of 4% dimeticone lotion for treatment of head louse infestation. Design Randomised controlled equivalence trial. Setting Community, with home visits. Participants 214 young people aged 4 to 18 years and 39 adults with active head louse infestation. Interventions Two applications seven days apart of either 4.0% dimeticone lotion, applied for eight hours or overnight, or 0.5% phenothrin liquid, applied for 12 hours or overnight. Outcome measures Cure of infestation (no evidence of head lice after second treatment) or reinfestation after cure. Results Cure or reinfestation after cure occurred in 89 of 127 (70%) participants treated with dimeticone and 94 of 125 (75%) treated with phenothrin (difference -5%, 95% confidence interval -16% to 6%). Per protocol analysis showed that 84 of 121 (69%) participants were cured with dimeticone and 90 of 116 (78%) were cured with phenothrin. Irritant reactions occurred significantly less with dimeticone (3/127, 2%) than with phenothrin (11/125, 9%; difference -6%, -12% to -1%). Per protocol this was 3 of 121 (3%) participants treated with dimeticone and 10 of 116 (9%) treated with phenothrin (difference -6%, -12% to -0.3%). Conclusion Dimeticone lotion cures head louse infestation. Dimeticone seems less irritant than existing treatments and has a physical action on lice that should not be affected by resistance to neurotoxic insecticides.

To generate evidence on the effectiveness of household-wide treatment for preventing the transmission of pediculosis capitis (head lice) in resource-poor communities. We studied 132 children without head lice who lived in a slum in north-eastern Brazil. We randomized the households of the study participants into an intervention and a control group and prospectively calculated the incidence of infestation with head lice among the children in each group. In the intervention group, all of the children's family members who lived in the household were treated with ivermectin; in the control group, no family member was treated. We used the chi(2) test with continuity correction or Fisher's exact test to compare proportions. We performed survival analysis using Kaplan-Meier estimates with log rank testing and the Mann-Whitney U test to analyse the length of lice-free periods among sentinel children, and we used Cox regression to analyse survival data on a multivariate level. We also carried out a subgroup analysis based on gender. Children in the intervention group remained free from infestation with head lice significantly longer than children in the control group. The median infestation-free period in the intervention group was 24 days (interquartile range, IQR: 11-45), as compared to 14 days (IQR: 11-25) in the control group (P = 0.01). Household-wide treatment with ivermectin proved significantly more effective among boys than among girls (P = 0.005). After treatment with ivermectin, the estimated number of annual episodes of head lice infestation was reduced from 19 to 14 in girls and from 15 to 5 in boys. Female sex and extreme poverty were independent risk factors associated with a shortened disease-free period. In an impoverished community, girls and the poorest of the poor are the population groups that are most vulnerable for head lice infestation. To decrease the number of head lice episodes per unit of time, control measures should include the treatment of all household contacts. Mass treatment with ivermectin may reduce the incidence of head lice infestation and associated morbidity in resource-poor communities.