Prevention of head louse infestation: a randomised, double-blind, cross-over study of a novel concept product, 1% 1,2-octanediol spray versus placebo.

OBJECTIVES: 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. SETTING: Randomised, double-blind, cross-over, community study in Cambridgeshire, UK. PARTICIPANTS: 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. INTERVENTIONS: 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. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary endpoint was the time taken until the first infestation event occurred. The secondary measure was safety of the product in regular use. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION NUMBER: ISRCTN09524995.

Can head louse repellents really work? Field studies of piperonal 2% spray.

Background. Many families find regular checking of children's heads for head louse infestation too onerous and would prefer to be able to prevent infestation by use of a topical application that deters lice from infesting the head. Identification in the laboratory of a repellent activity for piperonal provided the basis for developing a spray product to repel lice. Methods. A proof of principle field study in Dhaka, Bangladesh, compared the effect of using 2% piperonal spray with that of a placebo in 105 children and adults from three communities with infestation levels close to 100%. All participants were treated for infestation and subsequent incidence of reinfestation monitored daily by investigators. A second randomised, controlled, double blind, study in North London, UK, evaluated the effect of the product in normal use. One hundred and sixty-three children from schools with a high level (20-25%) of infestation were treated and confirmed louse free and randomly divided between 2% piperonal, a placebo spray, and a control group for up to 22 weeks. Parents applied the spray and monitored for infestation. Regular investigator visits confirmed the parental monitoring and replenished supplies of spray. Results. In Dhaka, over 18 days there were only 4 infestations in the piperonal group and 8 in the placebo group. This difference was not significant (p = 0.312). In North London, there were 41 cases of infestation over the course of the study. Although there were fewer infestations in the piperonal group, analysis of time to first infestation showed a no significant (p = 0.4368) difference between groups. Conclusion. Routine use of 2% piperonal spray in communities with a high prevalence of head louse infestation may provide some protection from infestation. However, the difference between use of the product and no active intervention was sufficiently small that regular checking for presence of lice is likely to be a more practical and cost effective approach to prevention of infestation.

Tocopheryl acetate 20% spray for elimination of head louse infestation: a randomised controlled trial comparing with 1% permethrin creme rinse.

BACKGROUND: Tocopheryl acetate is viscous oily fluid used in a range of preparations for skin and scalp care in Italy. Observational and in vitro data have suggested a high level of efficacy against head louse infestation. The purpose of this investigation was to confirm the activity of tocopheryl acetate in a clinical setting in comparison with a standard widely used preparation. METHODS: A spray formulation containing tocopheryl acetate 20% in cyclomethicone was compared with permethrin 1% creme rinse for treatment of head louse infestation in a randomised, assessor blind, trial. Forty-five people were treated on two occasions 7 days apart. The spray was applied to dry hair for 20 minutes then washed. Participants treated with permethrin washed their hair and towel dried it before treatment for 10 minutes. Assessments were made by dry detection combing 1, 6, 9, and 14 days after first treatment. RESULTS: The tocopheryl acetate 20% spray was significantly (p = 0.033) more effective than permethrin 1%, using intention to treat worst case analysis, in which there were 13/23 (56.5%) successful treatments for tocopheryl acetate compared with 5/22 (22.7%) for permethrin. After unprecedented issues of re-infestation within households had been taken into account the underlying cure rate was 17/23 (73.9%) for tocopheryl acetate compared with 5/22 (22.7%), Odds Ratio 9.63 (95% CI, 2.46 to 37.68) (p < 0.001). CONCLUSIONS: The tocopheryl acetate spray was significantly more effective than the permethrin product, was cosmetically acceptable, and not affected by current problems with resistance. TRIAL REGISTRATION: Current Controlled Trials ISRCTN45553737.

Single application of 4% dimeticone liquid gel versus two applications of 1% permethrin creme rinse for treatment of head louse infestation: a randomised controlled trial.

BACKGROUND: A 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. METHODS: We 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. RESULTS: Intention 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. CONCLUSIONS: The 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 REGISTRATION: Current Controlled Trials ISRCTN88144046.

Dimeticone 4% liquid gel found to kill all lice and eggs with a single 15 minute application.

BACKGROUND: Dimeticone 4% lotion is an effective and widely accepted treatment for head louse infestation. However, it is a highly mobile fluid that some people find difficult to apply and is mainly left on the hair for 8 hours or overnight. User preference is for a more manageable and viscous product that can be used with a short application time. FINDINGS: This proof of concept study in 41 people investigated dimeticone 4% liquid gel, a product that is easier to apply than the lotion, applied for 15 minutes on two occasions a week apart. We found that head lice were eliminated from all participants following the first application of product. We did not find lice of any stage on any participant during four post treatment assessments and particularly, unlike other treatments, no young nymphs on days 1 and 6 prior to the second treatment, indicating ovicidal as well as pediculicidal activity. CONCLUSIONS: Dimeticone 4% liquid gel has demonstrated efficacy greater than other similar products and the evidence obtained indicates elimination of head louse infestation with a single 15 minute application. TRIAL REGISTRATION: Current Controlled Trials ISRCTN59227204.

Soya oil-based shampoo superior to 0.5% permethrin lotion for head louse infestation.

BACKGROUND: This was a randomized, assessor-blind, controlled comparison of a soya oil- based medical device shampoo with a medicinal permethrin lotion in an alcohol vehicle for treatment of head louse infestation to generate data suitable for a regulatory submission to achieve reimbursable status for the shampoo product. METHODS: We treated 91 children and adults, divided between two sites, on two occasions 9 days apart. Participants washed their hair and towel-dried it before treatment. The shampoo was used twice for 30 minutes each time. The lotion was used for 30 minutes followed by rinsing. Assessments were made by dry detection combing on days 2, 9, 11, and 14 after the first treatment. According to present knowledge, this combing technique does not influence the overall head louse populations or outcome of treatment. RESULTS: The soya oil shampoo was significantly (P < 0.01) more effective than the lotion for both intention to treat (62.2% versus 34.8% successful treatment) and per-protocol (74.3% versus 36.8% success) groups. Post-treatment assessments showed the necessity for repeat treatment, but that a 9-day interval was too long because if eggs hatched after the first treatment, the lice could grow old enough to lay eggs before the second treatment. CONCLUSION: The soya oil-based shampoo was more effective than the permethrin lotion, more cosmetically acceptable, and less irritant.

Clinical trial showing superiority of a coconut and anise spray over permethrin 0.43% lotion for head louse infestation, ISRCTN96469780.

Permethrin is the most widely used pediculicide, but evidence of resistance from several countries and anecdotal reports from Germany suggest that permethrin lotion is now less effective. We designed a randomized, controlled, parallel group trial involving 100 participants with active head louse infestation to investigate the activity of a coconut and anise spray and to see whether permethrin lotion is still effective, using two applications of product 9 days apart. The spray was significantly more successful (41/50, 82.0%) cures compared with permethrin (21/50, 42.0%; p < 0.0001, difference 40.0%, 95% confidence interval of 22.5% to 57.5%). Per-protocol success was 83.3% and 44.7%, respectively. Thirty-three people reported irritant reactions following alcohol contact with excoriated skin. We concluded that, although permethrin lotion is still effective for some people, the coconut and anise spray can be a significantly more effective alternative treatment.