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DOI: 10.1111/j.1468-3083.2008.02829.x JEADV

SHORTBlackwell Publishing Ltd COMMUNICATION Control of head lice with a coconut-derived emulsion

M Connolly,† KA Stafford,‡ GC Coles,*‡ CTC Kennedy,† AMR Downs§ †Department of Dermatology, Bristol Dermatology Centre, Bristol Royal Infirmary, Bristol, UK ‡Department of Clinical Veterinary Science, University of Bristol, Langford House, Bristol, UK §Department of Dermatology, Royal Devon Hospital, Exeter, Devon, UK *Correspondence: GC Coles. E-mail: [email protected]

Abstract Objective To evaluate a novel coconut-derived emulsion (CDE) shampoo against head lice infestation in children. Design A school trial in which pupils were treated on days 0 and 7 and checked on days 8 and 15 and a family trial where product was applied by parents three times in 2 weeks or used as a cosmetic shampoo and checked on days 14 and days 70. Setting UK schools in Bristol and Western-super-Mare and families in Northern Somerset. Main outcome measure Numbers of children free from infestation after treatment. Results In the school trial, percentage cures at day 8 were 14% (permethrin, n = 7) and 61% (CDE, n = 37). In the family trial where all family members were treated, cure rate was 96% (n = 28), and if the shampoo was subsequently used as a cosmetic shampoo, only 1 of 12 children became re-infested after 10 weeks. Conclusion CDE shampoo is a novel effective method of controlling head lice and used after treatment as a cosmetic shampoo can aid in the reduction of re-infestation. Received: 13 February 2008; Accepted 12 March 2008

Keywords coconut-derived emulsion, control, head lice

Conflicts of interest None declared

In a school trial, infested children with parental consent were Resistance has been recorded to both permethrin and malathion treated with either a placebo (group 1), permethrin (group 2) or a in lice in the UK4 from the south-west and four further centres.5 novel coconut-derived emulsion (CDE; group 3). Each treatment Two of these areas showed the emergence of carbaryl resistance. was applied to wet hair and left on for 20 min. Treatment was Other groups recorded pyrethroid resistance in London6 and repeated 7 days later. On days 8 and 15, hair was dry combed, and malathion resistance in Wales.7 ‘Bug-busting’, the removal of lice the presence of lice was recorded. Percentage clearances at day 8 from hair coated with conditioner and combed with a fine-toothed were 14% (permethrin, n = 7) and 61% (CDE, n = 37). In a family louse comb has given cure rates of only 33% to 38%.6 Therefore, trial involving 43 infested children, CDE shampoo was applied to there is a clear need for an alternative method of control. dry hair three times in 2 weeks by parents, cure rate at 14 days Unpublished and anecdotal evidence from the US suggested were 96% (n = 30), and when used twice weekly as a normal that the CDE shampoo (Paramide Plus™), ‘a pesticide free cosmetic shampoo, there was a 77% cure rate. CDE shampoo is a cosmetically elegant cleanser for removing head lice and nits’ is novel method of head lice control, justifying large-scale trials. effective in the control of head lice. Therefore, a controlled clinical The head louse (Pediculus capitis) is an obligatory parasite of trial was undertaken in 12 primary schools from the South-west the human scalp that can cause symptoms of skin irritation, of England to establish the efficacy of the CDE preparation sleep loss and occasionally secondary bacterial infections resulting in comparison with a 1% permethrin treatment and a placebo from scratching. In a report for the WHO, Gratz1 stated that shampoo. When encouraging results were obtained from this infestation rates were high in both developing and developed trial, a preliminary family-based trial was conducted. countries (e.g., in the West Midlands in the UK).2 A 36-fold Ethical approval for two clinical trials in primary schools in increase in NHS prescriptions between 1980 and 1995 suggest a Bristol and Weston-super-Mare was obtained from the South- rise in the incidences of head lice infestations throughout the UK.3 west Research Ethics Committee. In trial one using dry combing

© 2008 The Authors JEADV 2009, 23, 67–69 Journal compilation © 2008 European Academy of Dermatology and Venereology

68 Connolly et al.

Table 1 The clearance of head lice from children treated with (1) cosmetic shampoo, (2) permethrin shampoo (Lyclear®) and (3) CDE shampoo Shampoo No. No. No. clear % given two N° infested on day 8 N° infested with No. clear treatment treated dropped out on day 8 treatments who (mixed stages adults adult lice only (%) on day 15 were clear on day 8 + immatures), % (1) Cosmetic 14 2 1 8 11 (92) 0 6 (50) (2) Permethrin 9 2 1 14 5 (72) 2 (40) 0 (3) CDE 41 4 23 61 3 (8) 12 (80) 22 (59)

with a fine-toothed louse comb, 64 infested children aged between Statistical analysis was carried out using Fisher’s exact test. To 5 and 11 with parental consent were identified and were randomly allow for three children in the same family being given the same assigned to one of three treatments. Placebo (group 1) were product, the numbers treated with CDE were reduced by two per treated with a cosmetic shampoo, reformulated to resemble the family in making the statistical analysis. CDE shampoo in particle size, group 2 received an over-the-counter In the school trial, nine females and five males were treated with head louse treatment (1% Lyclear®, Warner-Lambert, Hampshire, the placebo shampoo, but two withdrew before the second treat- UK), while group 3 were treated with the CDE shampoo (BioSafe ment. The pyrethroid treatment was given to nine females, but Technologies, Texas, USA). Since it became rapidly obvious to two withdrew before the second treatment. Thirty-three females both the operators and the subjects that the products could be and eight males were treated with the CDE shampoo, but three identified by smell (permethrin) and disappearance of lice (CDE), withdrew after the first treatment and one after the first check on a double-blind trial could not be undertaken. In one school, day 8. Only one child from the placebo group was clear on day 8 permission was only given to use the CDE shampoo. (confidence limits, 0–40% cures), but this had risen to six on day The hair of each child was thoroughly wetted with warm 15. One child treated with the pyrethroid was clear on day 8 , to adhere to the recommended use of permethrin, and and none on day 15. With the CDE shampoo, 23 children were the prescribed treatment applied. The scalp was massaged after negative on day 8 (confidence limits, 44–75% cures), and of those 15 min, and treatment washed off at 20 min. The hair was then who were positive, 12 had only adult lice, while 3 had lice of towel dried, combed with a standard hair care comb and mixed stages. Twenty-two children were still negative on day 15, blowed dry. This procedure was repeated on day 7. On days 8 although four of these had been positive on day 8. No significant and 15, each child was dry combed and assessed for the presence difference was found from the school where only CDE shampoo or absence of lice. Children were asked if they had experienced was used compared with the other schools. Percentage clear rates any side effects or adverse reactions from any of the treatments are shown in Table 1. at each visit. At day 8, there was a significant difference between the results For the second trial, children with parental consent were combed for group 1 (cosmetic shampoo) and group 3 (CDE shampoo; for the presence of head lice, and those found to be positive were P = 0.006) and between group 2 (permethrin) and group 3 given a pack describing in detail the study protocol. The research (P = 0.047) but not between groups 1 and 2 (P = 1.0) All siblings staff, which included a dermatology nurse from the United Bristol from two families (six children in total) were treated with the CDE Health Care Trust, visited those parents agreeing to take part, and shampoo in a preliminary trial of whole family treatments. All six family members were checked for the presence of lice and suitability were negative on days 8 and 5 were still negative on day 15, while for participation. Families were randomly allocated to one of one adult louse was found following an extensive comb on day 17 three groups. Group 1 applied the shampoo liberally to the dry of one sibling with long hair. scalp with massage after 15 min and rinse at 20 min, as recom- A total of 22 families with 56 children were recruited for the mended by the manufacturers. This treatment was undertaken family trial. and the results are given in Table 2. They show that three times over a 2-week interval, after which time families were the CDE has a very high efficacy if used as three 20-min treat- asked to keep a visual check on their offspring for the presence of ments during a 2-week period. The product was also efficacious lice. Group 2 subjects followed the same protocol as group 1 but when used as normal cosmetic shampoo and kept children effec- then used the product as a normal cosmetic shampoo at least twice tively free from infestation if used following a course of treatment. per week for the remainder of the trial. Group 3 used the product From the outset, none of the adults were infested with lice. Three as a replacement cosmetic shampoo for the 10 weeks of the trial. of the families that were in group 1 observed the return of lice Staff or parents under staff supervision checked family members within 2 weeks of finishing the final treatment and were provided at the end of weeks 2 and 10 except for participants in group 1 who had with more product to control the re-infestation. Two of the chil- opted out due to re-infestation by week 10. All families were dren in family 8 of group 3 were transitory only visiting the house- asked to report any adverse reactions due to the use of the shampoo. hold where treatment was given at weekends. Although lice were

© 2008 The Authors JEADV 2009, 23, 67–69 Journal compilation © 2008 European Academy of Dermatology and Venereology

Coconut emulsion kills head lice 69

Table 2 The numbers of infested children treated with CDE shampoo: Eighty per cent of children positive after treatment with the group 1 (three 20-min treatments over a 2-week period), group 2 as CDE shampoo had only adult head lice, suggesting rapid re- group 1 but with continued use of the products as a cosmetic shampoo infestation. As application of the product to dry hair might have and group 3 only using the product as a cosmetic shampoo increased the cure rate and lice could have transferred rapidly Family Number Number infested between children at school or at home, a second trial was run in number of children Day 0 Day 14 Day 70 which all family members were self-treated. Group 1 The second trial showed that CDE shampoo when applied by 1 3 3 0 Infested by day 28 parents to dry hair three times in 2 weeks performs extremely well 23 300 (94–100% clearance), but the product has no residual activity. 3 2 2 0 Infested by day 28 This is reflected in the need for repeat treatments to kill emerging 4 3 2 1 Infested by day 21 lice. The continued use of the shampoo following the prescribed 53 202 three treatments could effectively keep children lice-free where 6 3 1 0 Withdrew there is a significant challenge. The use of the CDE shampoo as a 73 202 cosmetic shampoo also proved effective in the majority of 82 100 children, but our impression was that it was less effective where Mean 2.8 2 0.125 children had heavy infestations. Further testing would be required % clear 94 to confirm this observation. Group 2 As CDE is a novel method of head lice control, free from chemical 13 300 insecticides and controls pyrethroid- and malathion-resistant lice, 22 200 its further evaluation would be justified in much large numbers of 32 100 families and on a community basis to see if transmission at school 43 200 could be stopped. 53 300 63 101 Acknowledgements Mean 2.7 2 0 0.17 This work was supported by a grant from BioSafe Technologies, % Clear 100 92 Inc., Texas, USA. Group 3 12 100 References 23 300 1 Gratz NG. Epidemiology of louse infestations. In international symposium on 32 100 control of lice and louse-borne diseases. P A H O. Sc Publ, 1973; 263: 23–31. 42 100 2 Smith S, Smith G, Heatlie H, Bashford J, Ashcroft D, Millson D. Head lice diagnosed in general practice in the West Midlands between 1993 and 2000: 53 212 a survey using the General Practice Research Database. Commmun Dis Public 61 100 Health 2003; 6: 139–143. 72 100 3 Downs AMR, Harvey I, Kennedy CTC. The epidemiology of head lice and 83 322 scabies in the UK. Epidem Infect 1999; 122: 471–477. 4 Downs AMR, Stafford KA, Harvey I, Coles GC. Evidence for double Mean 2.3 1.6 0.38 0.5 resistance to permethrin and malathion in head lice. Br J Dermatol 1999; 141: % clear 76 69 1–4. 5 Downs AMR, Stafford KA, Hunt LP, Ravenscroft JC, Coles GC. Widespread insecticide resistance in head lice to the over-the-counter pediculocides in England, and the emergence of carbaryl resistance. Br J Dermatol 2002; 146: present at both days 14 and 70, the guardian observed a reduction 88–93. in the numbers of lice present throughout the 10-week period. 6 Burgess IF, Brown CM, Peock S, Kaufman J. Head lice resistant to pyrethroid None of the children in the first trial nor any of the families insecticides in Britain. Br Med J 1995; 311: 88–93. 7 Roberts RJ, Casey D. Morgan DA, Petrovic M. Comparison of wet combing reported any adverse reaction to the product, and all participants with malathion for treatment of head lice in the UK: a pragmatic randomised expressed pleasure with its efficacy. controlled trial. Lancet 2000; 356: 540–544.

© 2008 The Authors JEADV 2009, 23, 67–69 Journal compilation © 2008 European Academy of Dermatology and Venereology