Dimeticone 4% gel

BackgroundInfestation with the human head louse (Pediculus humanus capitis) occurs worldwide. Existing treatment options are limited, and reports of resistance to commonly used pediculicides have been increasing. In this trial we assessed the efficacy of a product containing a high (92%) concentration of the silicone oil dimeticone (identical in composition to NYDA®), as compared to a 1% permethrin lotion.MethodsRandomized, controlled, observer blinded clinical trial. Participants were recruited from a poor urban neighbourhood in Brazil where pediculosis capitis was highly prevalent. To minimize reinfestation during the trial, participants (145 children aged 5–15 years with head lice infestations) were transferred to a holiday resort outside the endemic area for a period of 9 days. Two applications of dimeticone or 1% permethrin were done, seven days apart. Outcome measures were defined as cure (absence of vital head lice) after first application and before and after second applications, degree of itching, cosmetic acceptability, and clinical pathology.ResultsOverall cure rates were: day 2 – dimeticone 94.5% (95% CI: 86.6% – 98.5%) and permethrin 66.7% (95% CI: 54.6% – 77.3%; p < 0.0001); day 7 – dimeticone 64.4% (95% CI: 53.3% – 75.3%) and permethrin 59.7% (95% CI: 47.5% – 71.1%; p = 0.5); day 9 – dimeticone 97.2% (95% CI: 90.3% – 99.7%) and permethrin 67.6% (95% CI: 55.4%-78.2%); p < 0.0001). Itching was reduced similarly in both groups. Cosmetic acceptability was significantly better in the dimeticone group as compared to the permethrin group (p = 0.01). Two mild product-related incidents occurred in the dimeticone group.ConclusionThe dimeticone product is a safe and highly efficacious pediculicide. Due to its physical mode of action (interruption of the lice's oxygen supply of the central nervous system), development of resistance is unlikely.Trial registrationCurrent Controlled Trials ISRCTN15117709.

Abstract licence: CC BY 2.0

Tungiasis, a World Health Organization neglected tropical disease, is caused by the female sand flea. Most clinical trials for tungiasis use expensive or impractical drugs, which are difficult for residents to use. However, in western Kenya, communities successfully treat tungiasis with sodium carbonate. We hypothesise that the topical risk-difference of 5% sodium carbonate is no more than 10% non-inferior to dimeticone (NYDA®) for tungiasis treatment. This is a protocol for a non-inferiority study, which will be randomised and with an observer-blinded control. The study will have two arms: 5% sodium carbonate and NYDA®, one on each foot, and will take place at state primary schools in Homa Bay County, Kenya. Fleas identified among school children aged 8–14 years with sand-flea lesions will be enrolled in the study. For each participant, the viability of the embedded fleas, clinical signs including inflammation, and symptoms will be monitored for seven days after treatment. The proportion of dead fleas will be compared in the primary analysis. All adverse events will be monitored throughout the study period. We expect to identify the most effective treatment between sodium carbonate and NYDA® for tungiasis, which can be adopted in the community.

Abstract licence: CC BY 4.0

Background Tungiasis is a cutaneous parasitosis caused by the female flea Tunga penetrans. Two-component dimeticone (NYDA) is the only treatment for tungiasis recommended by the World Health Organization; however, this topical drug is not available in Kenya. In Western Kenya, sodium carbonate is commonly used in the treatment of tungiasis. This study evaluated the 7-day cure rates for tungiasis by comparing sodium carbonate and NYDA treatments in Homa Bay County, Kenya. Methodology/Principal findings This was a randomized, observer-blinded, parallel-treatment cohort trial. Twenty-three eligible children with 126 flea infections were matched and randomized. All participants received both treatments, with one treatment on each foot. We recorded all health conditions/information, including inflammation scores and adverse events. Observations were performed on days 3, 5, and 7 using a digital microscope to confirm dead or live fleas based on the viability signs. Twenty-three children aged 3–13 years were analyzed. The proportion of dead fleas on day 7 was higher after NYDA treatment than after 5% sodium carbonate treatment (87% versus 64%, respectively, P = 0.01) NYDA. Median survival was 5 days for both treatments; NYDA had significantly higher trend of flea non-viability rate than 5% sodium carbonate (P<0.01). There were no significant differences in the inflammation score or pain/itchiness between the two treatments. On the last day, 14 children indicated their preference for NYDA in future treatment of tungiasis, whereas nine children preferred the 5% sodium carbonate solution. Conclusions/Significance NYDA was significantly more effective than 5% sodium carbonate for tungiasis treatment. Both treatments were safe but the children preferred NYDA more. Future studies with more participants and an extended observation period are warranted to confirm our findings. The findings suggest that NYDA should be made more available in tungiasis endemic area. Trial registration UMIN-CTR; UMIN 000044320

Abstract licence: CC BY 4.0

Abstract Background Tungiasis is a cutaneous parasitic disease caused by the female flea Tunga penetrans. The World Health Organization recommends two-component dimeticone (NYDA®) as the sole treatment for tungiasis; however, this topical medication is not available in Kenya. In western Kenya, sodium carbonate has been adopted as a traditional village-based treatment. A pilot study found that the proportion of dead fleas on day 7 was higher with NYDA® treatment than that with 5% sodium carbonate treatment (87% vs. 64%, respectively). This study was aimed at assessing the 11-day cure rates of tungiasis by comparing the efficacy of sodium carbonate and NYDA® treatments in Vihiga County, Kenya. Methods A randomised, observer-blinded, non-inferiority trial was conducted, with the non-inferiority margin set at 10%. A total of 160 eligible children with 941 flea infections were matched and randomised. The number of lesions per child per foot ranged from 1 to 10, with a median of 5 lesions. Each participant received both treatments, with one treatment applied to each foot. Health conditions, including inflammation scores and adverse events, were recorded. Observations were recorded on days 3, 5, 7, 9, and 11 using a digital microscope to determine flea viability. Results Data from 157 children aged 4–15 years were analysed, comprising a total of 843 lesions. On day 11, the proportion of dead fleas was 88% for NYDA® and 77% for 5% sodium carbonate solution (p < 0.05). No significant differences were observed in inflammation scores or symptoms such as pain and itchiness between the two treatments. Conclusions This study demonstrated that 5% sodium carbonate did not meet the non-inferiority margin compared with NYDA® in treating tungiasis. Nevertheless, in settings where NYDA® is not accessible, it may still be considered an alternative. Trial registration This study was registered with UMIN-CTR (Trial ID: UMIN000044320; reception desk number: R000050621) on 28 May 2021.

Abstract licence: CC BY 4.0

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

Abstract licence: CC BY 4.0

BackgroundHead 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.MethodsBefore 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 ResultsFrom 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.ConclusionsDimeticone 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 registrationCurrent Controlled Trials- IRCT2016041627408N1 , Dated: 21-08-2017.

Abstract licence: CC BY

BackgroundA previous study indicated that a single application of 4% dimeticone liquid gel was effective in treating head louse infestation. This study was designed to confirm this in comparison with two applications of 1% permethrin.MethodsWe have performed a single centre parallel group, randomised, controlled, open label, community based trial, with domiciliary visits, in Cambridgeshire, UK. Treatments were allocated through sealed instructions derived from a computer generated list. We enrolled 90 children and adults with confirmed head louse infestation analysed by intention to treat (80 per-protocol after 4 drop outs and 6 non-compliant). The comparison was between 4% dimeticone liquid gel applied once for 15 minutes and 1% permethrin creme rinse applied for 10 minutes, repeated after 7 days as per manufacturer’s directions. Evaluated by elimination of louse infestation after completion of treatment application regimen.ResultsIntention to treat comparison of a single dimeticone liquid gel treatment with two of permethrin gave success for 30/43 (69.8%) of the dimeticone liquid gel group and 7/47 (14.9%) of the permethrin creme rinse group (OR 13.19, 95% CI 4.69 to 37.07) (p < 0.001). Per protocol results were similar with 27/35 (77.1%) success for dimeticone versus 7/45 (15.6%) for permethrin. Analyses by household gave essentially similar outcomes.ConclusionsThe study showed one 15 minute application of 4% dimeticone liquid gel was superior to two applications of 1% permethrin creme rinse (p < 0.001). The low efficacy of permethrin suggests it should be withdrawn.Trial registrationCurrent Controlled Trials ISRCTN88144046.

Abstract licence: CC BY 2.0

BackgroundPediculosis capitis is a common human parasitic infestation in childhood. This article aims to provide a narrative updated review on the management of pediculosis capitis.MethodsA PubMed search was performed with Clinical Queries using the key terms "pediculosis capitis" OR "head lice" OR "head louse". The search strategy included clinical trials, meta-analyses, randomized controlled trials, observational studies and reviews published within the past 10 years. The search was restricted to articles published in English literature. The information retrieved from the search was used in the compilation of the present article.ResultsTopical permethrin and pyrethrin formulated with piperonyl butoxide are the pediculicides of choice in areas where resistance to these products is low. When resistance to these products is suspected based on local levels of resistance or when treatment with these products fails despite their correct use, and reinfestation does not seem to be responsible, other topical treatment options include malathion, benzyl alcohol, dimethicone, spinosad and ivermectin. Wet combing should be considered for children younger than 2 years. Oral ivermectin and trimethoprim/sulfamethoxazole should be reserved for patients who do not respond to appropriate topical pediculicides.ConclusionMany topical pediculicides are effective for the treatment of pediculosis capitis. The use of some of these pediculicides is limited for safety reasons, especially in children younger than 2 years. Resistance to pediculicides, especially those with a neurotoxic mode of action, is another concern which may limit the use of some of these pediculicides. New products should be evaluated for effectiveness and safety. Wet combing is time-consuming and should not be used as the sole intervention in the general population.

Abstract licence: CC BY-NC-ND