Effect of a New Head Lice Treatment, Abametapir Lotion, 0.74%, on Louse Eggs: A Randomized, Double-Blind Study.
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ABSTRACT:
SUBMITTER: Bowles VM
PROVIDER: S-EPMC6388454 | biostudies-literature | 2019
REPOSITORIES: biostudies-literature
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Effect of a New Head Lice Treatment, Abametapir Lotion, 0.74%, on Louse Eggs: A Randomized, Double-Blind Study.
Bowles Vernon Morrison VM Hanegraaf Sharon S Ahveninen Tiina T Sidgiddi Srinivas S Allenby Kent K Alsop Hugh H
Global pediatric health 20190222
Few head lice treatments have demonstrated effectiveness against louse eggs. Abametapir, a metalloproteinase inhibitor, is able to target metalloproteinases critical to egg hatching and louse development. In this double-blind, phase 2 study, 50 subjects aged ≥3 years with active head lice infestation were randomized to receive a single treatment of abametapir lotion, 0.74%, or vehicle (control), applied to scalp and hair for 10 minutes. Ovicidal efficacy was measured by recording the hatch rate ...[more]
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Project description:BACKGROUND:There is a need for better control of head louse infestations. Abametapir is an inhibitor of metalloproteinases critical for louse survival and egg development. The efficacy of abametapir lotion, 0.74%, was assessed for its ability to clear head louse infestations after a single application. METHODS:Two randomized, double-blind, multicenter, vehicle-controlled studies were conducted in subjects aged 6 months and older to compare the effectiveness of abametapir lotion versus vehicle control for eliminating head louse infestations without nit combing. Abametapir lotion was applied to dry hair for 10 minutes on day 0 and then rinsed with water. The primary endpoint was the proportion of index subjects (youngest household member with ? 3 live lice at screening) in the intent-to-treat population who were louse free at all follow-up visits through day 14. Older household members with one or more live lice at screening were designated as nonindex subjects and treated as per the index subject within their household. RESULTS:In the intent-to-treat population (index subjects, N = 216), 81.5% of subjects treated with abametapir lotion were louse free through day 14 after a single treatment, versus 49.1% with vehicle (P < 0.001). For the combined index and nonindex population (N = 704), 85.9% were louse free through day 14 in the abametapir group, versus 61.3% in the vehicle group (P < 0.001). The most frequently reported adverse events were erythema (4.0%), rash (3.2%), and skin burning sensation (2.6%). CONCLUSION:Abametapir lotion, 0.74%, was effective at clearing active head louse infestations through day 14 in subjects aged 6 months and older. All adverse events (including one serious but unrelated to study drug) resolved uneventfully.
| S-EPMC6175393 | biostudies-literature
Project description:BACKGROUND:Malathion 0.5% has been the most prescribed pediculicide in the United Kingdom for around 10 years, and is widely used in Europe and North America. Anecdotal reports suggest malathion treatments are less effective than formerly, but this has not been confirmed clinically. This study was designed to determine whether malathion is still effective and if 4% dimeticone lotion is a more effective treatment for head louse infestation. METHODOLOGY/PRINCIPAL FINDINGS:We designed this study as an assessor blinded, randomised, controlled, parallel group trial involving 58 children and 15 adults with active head louse infestation. Each participant received two applications 7 days apart of either 4% dimeticone lotion, applied for 8 hours or overnight, or 0.5% malathion liquid applied for 12 hours or overnight. All treatment and check-up visits were conducted in participants' homes. Cure of infestation was defined as no evidence of head lice after the second treatment. Some people were found free from lice but later reinfested. Worst case, intention to treat, analysis found dimeticone was significantly more effective than malathion, with 30/43 (69.8%) participants cured using dimeticone compared with 10/30 (33.3%) using malathion (p<0.01, difference 36.4%, 95% confidence interval 14.7% to 58.2%). Per protocol analysis showed cure rates of 30/39 (76.9%) and 10/29 (34.5%) respectively. Irritant reactions were observed in only two participants, both treated with malathion. CONCLUSIONS/SIGNIFICANCE:We concluded that, although malathion liquid is still effective for some people, dimeticone lotion offers a significantly more effective alternative treatment for most people. TRIAL REGISTRATION:Controlled-Trials.com ISRCTN47755726.
| S-EPMC2043492 | biostudies-literature
Project description:Context. During the late 1990s, insecticide resistance had rendered a number of treatment products ineffective; some companies saw this as an opportunity to develop alternative types of treatment. We investigated the possibility that a surfactant-based lotion containing 10% cocamide diethanolamine (cocamide DEA) was effective to eliminate head louse infestation. Settings and Design. Initial in vitro testing of the lotion formulation versus laboratory reared body/clothing lice, followed by two randomised, controlled, community-based, assessor blinded, clinical studies. Materials and Methods. Preliminary laboratory tests were performed by exposing lice or louse eggs to the product using a method that mimicked the intended use. Clinical Study 1: Children and adults with confirmed head louse infestation were treated by investigators using a single application of aqueous 10% cocamide DEA lotion applied for 60 min followed by shampooing or a single 1% permethrin creme rinse treatment applied to pre-washed hair for 10 min. Clinical Study 2: Compared two treatment regimens using 10% cocamide DEA lotion that was concentrated by hair drying. A single application left on for 8 h/overnight was compared with two applications 7 days apart of 2 h duration, followed by a shampoo wash. Results. The initial laboratory tests showed a pediculicidal effect for a 60 min application but limited ovicidal effect. A longer application time of 8 h or overnight was found capable of killing all eggs but this differed between batches of test material. Clinical Study 1: Both treatments performed badly with only 3/23 (13%) successful treatments using cocamide DEA and 5/25 (23.8%) using permethrin. Clinical Study 2: The single overnight application of cocamide DEA concentrated by hair drying gave 10/56 (17.9%) successes compared with 19/56 (33.9%) for the 2 h application regimen repeated after 1 week. Intention to treat analysis showed no significant difference (p = 0.0523) between the treatments. Over the two studies, there were 18 adverse events possibly or probably associated with treatment, most of which were increased pruritus after treatment. Conclusions. Cocamide DEA 10% lotion, even when concentrated by hair drying, showed limited activity to eliminate head louse infestation.
| S-EPMC4636399 | biostudies-literature
Project description:IntroductionSilicones (e.g., dimethicone) are effective and safe alternatives to insecticides for the treatment of head lice. However, silicones are lipophilic substances and do not only leave the hair greasy but they are also difficult to wash out. We have evaluated the efficacy and safety of a potential solution to this problem: an aqueous dispersion of a novel silylated polyol that has the same mode of action as dimethicone (suffocation) without its negative impact on hair characteristics.MethodsThis was a randomized, controlled, investigator-blinded, bicentric study that was conducted at two locations in the state of Florida (USA) to compare the test product (medical device) to a pyrethrum-based pediculicide that is a first-line, prescription-free treatment against head lice in the USA. The subjects (n = 70) were randomly divided into two groups of 35 persons (test product group and reference product group), with each participant receiving two applications (day 0 and 7) of the product to be tested, according to the instructions for use. Efficacy and safety was evaluated at distinct time points. The primary objective was to establish a cure rate for the test product that was better than 70% at study end (day 10). Esthetic effects of the test product versus dimethicone were evaluated in a blinded, cross-over consumer study (n = 100).ResultsAt study end, the cure rate (corrected for re-infestation) of 88.2% with the test product significantly surpassed the pre-defined target of 70%, and thus the superiority of the test product versus the reference product was confirmed. The number of subjects cured (free of head lice) after the first treatment was remarkably higher with the test product than with the reference product (57.1 vs. 2.9%, respectively). Both products were safe and well tolerated and both showed beneficial esthetical effects. The consumer test demonstrated that the test product had better washing-out properties than dimethicone, as reflected by a significantly lower average rinsing time and number of washings required to restore the visual aspect of the hair, especially in terms of greasiness.ConclusionAqueous dispersions of silylated polyols are a promising new class of pediculicides that combine high cure rates with optimal user convenience (short treatment period, easy wash-out with positive effect on hair quality).Trial registrationClinicalTrials.gov identifier, NCT03617926.FundingOystershell Laboratories.
| S-EPMC6380969 | biostudies-literature
Project description:BACKGROUND: Genetic analyses of human lice have shown that the current taxonomic classification of head lice (Pediculus humanus capitis) and body lice (Pediculus humanus humanus) does not reflect their phylogenetic organization. Three phylotypes of head lice A, B and C exist but body lice have been observed only in phylotype A. Head and body lice have different behaviours and only the latter have been involved in outbreaks of infectious diseases including epidemic typhus, trench fever and louse borne recurrent fever. Recent studies suggest that body lice arose several times from head louse populations. METHODS AND FINDINGS: By introducing a new genotyping technique, sequencing variable intergenic spacers which were selected from louse genomic sequence, we were able to evaluate the genotypic distribution of 207 human lice. Sequence variation of two intergenic spacers, S2 and S5, discriminated the 207 lice into 148 genotypes and sequence variation of another two intergenic spacers, PM1 and PM2, discriminated 174 lice into 77 genotypes. Concatenation of the four intergenic spacers discriminated a panel of 97 lice into 96 genotypes. These intergenic spacer sequence types were relatively specific geographically, and enabled us to identify two clusters in France, one cluster in Central Africa (where a large body louse outbreak has been observed) and one cluster in Russia. Interestingly, head and body lice were not genetically differentiated. CONCLUSIONS: We propose a hypothesis for the emergence of body lice, and suggest that humans with both low hygiene and head louse infestations provide an opportunity for head louse variants, able to ingest a larger blood meal (a required characteristic of body lice), to colonize clothing. If this hypothesis is ultimately supported, it would help to explain why poor human hygiene often coincides with outbreaks of body lice. Additionally, if head lice act as a reservoir for body lice, and that any social degradation in human populations may allow the formation of new populations of body lice, then head louse populations are potentially a greater threat to humans than previously assumed.
| S-EPMC2843630 | biostudies-literature
Project description:In this investigation of effectiveness of an alternative pediculicide dosage form, we recruited 228 children and 50 adult participants from Bedfordshire, UK, to a randomised, controlled, assessor blind trial comparing two insecticide products with mechanical removal of lice as a control group. Participants using insecticide were treated with either the investigative 0.5% phenothrin mousse, for 30 minutes, or 0.2% phenothrin lotion, for 2 hours as the reference product. Both treatments were applied only once, followed by shampoo washing. Those treated by wet-combing with conditioner were combed 4 times over 12 days. Parents/carers carried out the treatments to mimic normal consumer use. The outcome measure was the absence of lice, 14 days after treatment for the insecticides, and up to 14 days after completion of combing. Intention to treat analysis of the outcomes for 275 participants showed success for phenothrin mousse in 21/105 (20.0%), in 23/107 (21.5%) for phenothrin lotion, and in 12/63 (19.1%) for wet-combing. People receiving mousse were 1.07 (95% CI, 0.63 to 1.81) times more likely to still have lice after treatment compared with those treated with lotion. The group of participants who received the wet combing treatment were 1.13 (95% CI, 0.61 to 2.11) times more likely to still have lice after the treatment. None of the treatments was significantly (p < 0.05) more effective than any other. This study was carried out in an area where moderate resistance to phenothrin was demonstrated after the study by using a bioassay. Analysis of post treatment assessments found that failure of insecticides to kill louse eggs had influenced the outcome.
| S-EPMC4168840 | biostudies-literature
Project description:To determine whether regular use of a spray containing 1,2-octanediol 1%, which has been shown to inhibit survival of head lice, is able to work as a preventive against establishment of new infestations.Randomised, double-blind, cross-over, community study in Cambridgeshire, UK.63 male and female schoolchildren aged 4-16 years judged to have a high risk of recurrent infestation. Only the youngest member of a household attending school participated.Participants were treated to eliminate lice, randomised between 1% octanediol or placebo sprays for 6?weeks then crossed-over to the other spray for 6?weeks. Parents applied the sprays at least twice weekly or more frequently if the hair was washed. Investigators monitored weekly for infestation and replenished supplies of spray.The primary endpoint was the time taken until the first infestation event occurred. The secondary measure was safety of the product in regular use.Intention-to-treat analysis found a total of 32 confirmed infestations in 20 participants, with 9 of them infested while using both products. In these nine participants the time to first infestation showed a significant advantage to 1% octanediol (p=0.0129). Per-protocol analysis showed only trends because the population included was not large enough to demonstrate significance. There were no serious adverse events and only two adverse events possibly related to treatment, one was a case of transient erythema and another of a rash that resolved after 5?days.Routine use of 1% octanediol spray provided a significant level of protection from infestation. It was concluded that this product is effective if applied regularly and thoroughly.ISRCTN09524995.
| S-EPMC4039848 | biostudies-other
Project description:Pyrethroid insecticides are the only pesticides approved for the treatment of head lice (pediculosis capitis) infestations in Japan. However, in Okinawa Prefecture, 96% of head lice are resistant to pyrethroids. Here, we conducted a clinical trial to assess the safety and efficacy of a dimethicone preparation against head lice infestations in Okinawa Prefecture. Dimethicone-containing lotion was applied over the entire scalp three times over a 7-day period. Lice bodies (nymphs/adults) and eggs (nits) were counted before (day 0) and after treatment (day 8); a subset of eggs was collected to estimate viability based on hatch rate. Efficacy was evaluated based on improvement (reduction) in head lice counts post-treatment with respect to baseline. Safety was evaluated based on subjects' scalp condition and adverse event incidence. Utility was a composite end-point combining efficacy and safety. In total, 35 subjects were enrolled. Efficacy and safety were evaluated in 23 and 35 subjects, respectively. No side-effects of note were reported during the treatment period. The dimethicone lotion resulted in a utility rating of "marginally useful" or higher in over 80% of the study population, signifying the formulation to be both safe and effective. The dimethicone lotion was also a potent ovicide; 99.4% of eggs collected after treatment failed to hatch when incubated. Eradication of head lice remained successful for at least 4 weeks after the final topical dimethicone application in 25 of the 28 subjects reached by telephone survey. Lice bodies and eggs were genotyped to analyze the prevalence of three knockdown resistance (kdr)-type mutations within the voltage-sensitive sodium channel known to confer pyrethroid resistance. One or more kdr mutations were confirmed in 30 of the 32 subjects from whom specimens were collected (93.8%). Dimethicone was confirmed to be both safe and effective in treating pyrethroid-resistant head lice.
| S-EPMC8453846 | biostudies-literature
Project description:UnlabelledSymptoms after human infection with the helminth Trichuris suis have not previously been described. Exposure to helminths has been suggested as immune therapy against allergy and autoimmune diseases. We randomized adults with allergic rhinitis to ingest a dose of 2500 T. suis eggs or placebo every 21 days for 168 days (total 8 doses) in a double-blind clinical trial. In a previous publication, we reported a lack of efficacy and a high prevalence of adverse gastrointestinal reactions. The aim of the present study was to present a detailed description of the adverse event data and post-hoc analyses of gastrointestinal reactions. Adverse events and severity (mild, moderate, severe) were recorded daily by subjects, classified by organ using MedDRA 10.0, and event rates compared between subjects on T. suis treatment vs. subjects on placebo. T. suis-specific serum IgG antibodies were measured by a fluoroenzymeimmunoassay (Phadia ApS). During 163 days complete follow-up, subjects ingesting T. suis eggs (N = 49) had a three to 19-fold higher rate of events (median duration, 2 days) with gastrointestinal reactions (moderate to severe flatulence, diarrhea, and upper abdominal pain) compared with placebo subjects (N = 47). The highest incidence of affected subjects was seen from the first few days and until day 42 (3(rd) dose): 63% vs. 29% for placebo; day 163: 76% vs. 49% for placebo. Seroprevalences increased concurrently in the T. suis group: Day 59, 50%; day 90, 91%; day 170, 93%. The combined duration of episodes with onset before day 42 was ? 14 days in 80% of affected subjects. Age, gender, total IgE, and recent intestinal symptoms at baseline did not predict gastrointestinal side effects. In conclusion, during the first 2 months, repeated ingestions of 2500 T. suis eggs caused frequent gastrointestinal reactions lasting up to 14 days, whereas 4 months further treatment mainly provoked a subclinical stimulation.Trial registrationUniversity hospital Medical Information Network trial registry Reg. no. R000001298, Trial ID UMIN000001070.
| S-EPMC3149054 | biostudies-literature
Project description:Head lice infestation is an emerging social problem in undeveloped and developed countries. Because of louse resistance increasing, several long-used insecticidal compounds have lost their efficacy, and alternatives, such as essential oils, have been proposed to treat this parasitic infestation. The present study investigated the efficacy of two natural substances: tea tree (Melaleuca alternifolia) oil and nerolidol (3,7,11-trimethyl-1,6,10-dodecatrien-3-ol) against lice and its eggs. Products were used alone and in combination (ratio 1:1 and 1:2) from 8 % dilution. The in vitro effect of natural substances at different concentrations were evaluated against 69 head lice (adults and nymphs) and 187 louse eggs collected from school children in Chieti-Pescara (Central Italy) over a 6-month period. The lice mortality was evaluated for 24 h by a stereo light microscope. The ovicidal activity was monitored by microscopic inspections for 15 days. Tea tree oil was more effective than nerolidol against head lice with 100 % mortality at 30 min and 1 % concentration. On the contrary, nerolidol expressed a more pronounced ovicidal activity inducing the failure of 50 % of the eggs to hatch at 1 % concentration after 4 days; the same effect was achieved by using a twice concentration of tea tree oil. The association of the two substances both in ratios 1:1 and 1:2 combined efficaciously their insecticidal and ovicidal effect; in particular, the ratio 1:2 (tea tree oil 0.5 % plus nerolidol 1 %) acted producing both the death of all head lice at 30 min and the abortive effect of louse eggs after 5 days. These results offer new potential application of natural compounds and display a promising scenario in the treatment of pediculosis resistant cases. The development of novel pediculicides containing essential oils could be, in fact, an important tool to control the parasitic infestation.
| S-EPMC3480584 | biostudies-literature