A randomized, assessor-blind, parallel-group, multicentre, phase IV comparative trial of a suffocant compared with malathion in the treatment of head lice in children
ABSTRACT Background/Objectives: There are concerns about the effectiveness of head lice treatments because of increasing resistance and safety. This trial compared the safety and efficacy of a suffocant‐based head lice treatment to malathion in children. Methods: The trial used strict entry criter...
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| Veröffentlicht in: | Australasian journal of dermatology 2010-08, Vol.51 (3), p.175-182 |
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| container_title | Australasian journal of dermatology |
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| creator | Greive, Kerryn A Lui, Ada H Barnes, Tanya M Oppenheim, VM Jane |
| description | ABSTRACT
Background/Objectives: There are concerns about the effectiveness of head lice treatments because of increasing resistance and safety. This trial compared the safety and efficacy of a suffocant‐based head lice treatment to malathion in children.
Methods: The trial used strict entry criteria, standardized treatment and assessment regimens, sibling treatment where appropriate and a primary efficacy end‐point defined as the absence of live head lice.
Results: A total of 216 children were enrolled. One hundred and sixty‐nine were per‐protocol. The suffocant was significantly more effective than malathion for the intention‐to‐treat population (53.9% vs 40.4% louse‐free, unadjusted P = 0.052; adjusted P = 0.024), as well as for the per‐protocol population (57.8% vs 43.0% louse‐free, unadjusted P = 0.054; adjusted P = 0.045). Adverse events were limited to itching or stinging and there were no serious or systemic adverse events. Repeat insult patch testing with the suffocant resulted in no adverse reactions. In vitro tests confirmed that the suffocant is a potent ovicide and pediculicide with 100% mortality of eggs and lice following a 20‐min contact time.
Conclusions: The suffocant is shown to be significantly more effective in eliminating head lice than malathion in children, while being associated with a low incidence of mild, transient adverse events. |
| doi_str_mv | 10.1111/j.1440-0960.2010.00622.x |
| format | Article |
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Background/Objectives: There are concerns about the effectiveness of head lice treatments because of increasing resistance and safety. This trial compared the safety and efficacy of a suffocant‐based head lice treatment to malathion in children.
Methods: The trial used strict entry criteria, standardized treatment and assessment regimens, sibling treatment where appropriate and a primary efficacy end‐point defined as the absence of live head lice.
Results: A total of 216 children were enrolled. One hundred and sixty‐nine were per‐protocol. The suffocant was significantly more effective than malathion for the intention‐to‐treat population (53.9% vs 40.4% louse‐free, unadjusted P = 0.052; adjusted P = 0.024), as well as for the per‐protocol population (57.8% vs 43.0% louse‐free, unadjusted P = 0.054; adjusted P = 0.045). Adverse events were limited to itching or stinging and there were no serious or systemic adverse events. Repeat insult patch testing with the suffocant resulted in no adverse reactions. In vitro tests confirmed that the suffocant is a potent ovicide and pediculicide with 100% mortality of eggs and lice following a 20‐min contact time.
Conclusions: The suffocant is shown to be significantly more effective in eliminating head lice than malathion in children, while being associated with a low incidence of mild, transient adverse events.</description><identifier>ISSN: 0004-8380</identifier><identifier>EISSN: 1440-0960</identifier><identifier>DOI: 10.1111/j.1440-0960.2010.00622.x</identifier><identifier>PMID: 20695855</identifier><identifier>CODEN: AJDEBP</identifier><language>eng</language><publisher>Melbourne, Australia: Blackwell Publishing Asia</publisher><subject>Adult ; Aged ; Animals ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antiparasitic agents ; Asphyxia - chemically induced ; Biological and medical sciences ; Child ; Child, Preschool ; children ; clinical trial ; Dermatology ; Exanthema - chemically induced ; Female ; General aspects ; head lice ; Humans ; Insecticides - therapeutic use ; Lice Infestations - drug therapy ; malathion ; Malathion - adverse effects ; Malathion - therapeutic use ; Male ; Medical sciences ; Middle Aged ; Pediculus - drug effects ; Pharmacology. Drug treatments ; resistance ; Scalp - drug effects ; Single-Blind Method ; suffocation ; Treatment Outcome ; Young Adult</subject><ispartof>Australasian journal of dermatology, 2010-08, Vol.51 (3), p.175-182</ispartof><rights>2010 The Authors. Journal compilation © 2010 The Australasian College of Dermatologists</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4672-9c71def3d0ece85cdf9444187e8a45433c39e172fee8de71d0d91db6399112593</citedby><cites>FETCH-LOGICAL-c4672-9c71def3d0ece85cdf9444187e8a45433c39e172fee8de71d0d91db6399112593</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fj.1440-0960.2010.00622.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fj.1440-0960.2010.00622.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=23099491$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20695855$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Greive, Kerryn A</creatorcontrib><creatorcontrib>Lui, Ada H</creatorcontrib><creatorcontrib>Barnes, Tanya M</creatorcontrib><creatorcontrib>Oppenheim, VM Jane</creatorcontrib><title>A randomized, assessor-blind, parallel-group, multicentre, phase IV comparative trial of a suffocant compared with malathion in the treatment of head lice in children</title><title>Australasian journal of dermatology</title><addtitle>Australas J Dermatol</addtitle><description>ABSTRACT
Background/Objectives: There are concerns about the effectiveness of head lice treatments because of increasing resistance and safety. This trial compared the safety and efficacy of a suffocant‐based head lice treatment to malathion in children.
Methods: The trial used strict entry criteria, standardized treatment and assessment regimens, sibling treatment where appropriate and a primary efficacy end‐point defined as the absence of live head lice.
Results: A total of 216 children were enrolled. One hundred and sixty‐nine were per‐protocol. The suffocant was significantly more effective than malathion for the intention‐to‐treat population (53.9% vs 40.4% louse‐free, unadjusted P = 0.052; adjusted P = 0.024), as well as for the per‐protocol population (57.8% vs 43.0% louse‐free, unadjusted P = 0.054; adjusted P = 0.045). Adverse events were limited to itching or stinging and there were no serious or systemic adverse events. Repeat insult patch testing with the suffocant resulted in no adverse reactions. In vitro tests confirmed that the suffocant is a potent ovicide and pediculicide with 100% mortality of eggs and lice following a 20‐min contact time.
Conclusions: The suffocant is shown to be significantly more effective in eliminating head lice than malathion in children, while being associated with a low incidence of mild, transient adverse events.</description><subject>Adult</subject><subject>Aged</subject><subject>Animals</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antiparasitic agents</subject><subject>Asphyxia - chemically induced</subject><subject>Biological and medical sciences</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>children</subject><subject>clinical trial</subject><subject>Dermatology</subject><subject>Exanthema - chemically induced</subject><subject>Female</subject><subject>General aspects</subject><subject>head lice</subject><subject>Humans</subject><subject>Insecticides - therapeutic use</subject><subject>Lice Infestations - drug therapy</subject><subject>malathion</subject><subject>Malathion - adverse effects</subject><subject>Malathion - therapeutic use</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Pediculus - drug effects</subject><subject>Pharmacology. Drug treatments</subject><subject>resistance</subject><subject>Scalp - drug effects</subject><subject>Single-Blind Method</subject><subject>suffocation</subject><subject>Treatment Outcome</subject><subject>Young Adult</subject><issn>0004-8380</issn><issn>1440-0960</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkctu1DAUhiMEokPhFZA3iE0z2LGdxBKbUaEXNAKhQru0PPYJ8eAkU9uh0z4Qz4nDDMMSvPHlfP-x5S_LEMFzksab9ZwwhnMsSjwvcDrFuCyK-fZRNjsUHmczjDHLa1rjo-xZCGuMCSWcP82OClwKXnM-y34ukFe9GTr7AOYEqRAghMHnK2f7tN8or5wDl3_zw7g5Qd3ootXQRw-p2KoA6PIa6aGbwGh_AIreKoeGBikUxqYZtOrjHgCD7mxsUaeciq0demR7FNspAyp2qeuUa0EZ5NIlU1W31hkP_fPsSaNcgBf7-Tj7evb-y-lFvvx0fnm6WOaalVWRC10RAw01GDTUXJtGMMZIXUGtGGeUaiqAVEUDUBtILDaCmFVJhSCk4IIeZ693fTd-uB0hRNnZoME51cMwBllxxmnFKf03yWpRcFaUiax3pPZDCB4aufG2U_5eEiwnnXItJ2tysiYnnfK3TrlN0Zf7S8ZVB-YQ_OMvAa_2gApauSa51Db85SgWggmSuLc77s46uP_vB8jFh3dpkeL5Lm5DhO0hrvx3WVbpP-TNx3O5LM_Km89XV_Ka_gIzFcwG</recordid><startdate>201008</startdate><enddate>201008</enddate><creator>Greive, Kerryn A</creator><creator>Lui, Ada H</creator><creator>Barnes, Tanya M</creator><creator>Oppenheim, VM Jane</creator><general>Blackwell Publishing Asia</general><general>Wiley-Blackwell</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>7SS</scope></search><sort><creationdate>201008</creationdate><title>A randomized, assessor-blind, parallel-group, multicentre, phase IV comparative trial of a suffocant compared with malathion in the treatment of head lice in children</title><author>Greive, Kerryn A ; Lui, Ada H ; Barnes, Tanya M ; Oppenheim, VM Jane</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4672-9c71def3d0ece85cdf9444187e8a45433c39e172fee8de71d0d91db6399112593</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Animals</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antiparasitic agents</topic><topic>Asphyxia - chemically induced</topic><topic>Biological and medical sciences</topic><topic>Child</topic><topic>Child, Preschool</topic><topic>children</topic><topic>clinical trial</topic><topic>Dermatology</topic><topic>Exanthema - chemically induced</topic><topic>Female</topic><topic>General aspects</topic><topic>head lice</topic><topic>Humans</topic><topic>Insecticides - therapeutic use</topic><topic>Lice Infestations - drug therapy</topic><topic>malathion</topic><topic>Malathion - adverse effects</topic><topic>Malathion - therapeutic use</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Pediculus - drug effects</topic><topic>Pharmacology. Drug treatments</topic><topic>resistance</topic><topic>Scalp - drug effects</topic><topic>Single-Blind Method</topic><topic>suffocation</topic><topic>Treatment Outcome</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Greive, Kerryn A</creatorcontrib><creatorcontrib>Lui, Ada H</creatorcontrib><creatorcontrib>Barnes, Tanya M</creatorcontrib><creatorcontrib>Oppenheim, VM Jane</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>Entomology Abstracts (Full archive)</collection><jtitle>Australasian journal of dermatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Greive, Kerryn A</au><au>Lui, Ada H</au><au>Barnes, Tanya M</au><au>Oppenheim, VM Jane</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized, assessor-blind, parallel-group, multicentre, phase IV comparative trial of a suffocant compared with malathion in the treatment of head lice in children</atitle><jtitle>Australasian journal of dermatology</jtitle><addtitle>Australas J Dermatol</addtitle><date>2010-08</date><risdate>2010</risdate><volume>51</volume><issue>3</issue><spage>175</spage><epage>182</epage><pages>175-182</pages><issn>0004-8380</issn><eissn>1440-0960</eissn><coden>AJDEBP</coden><abstract>ABSTRACT
Background/Objectives: There are concerns about the effectiveness of head lice treatments because of increasing resistance and safety. This trial compared the safety and efficacy of a suffocant‐based head lice treatment to malathion in children.
Methods: The trial used strict entry criteria, standardized treatment and assessment regimens, sibling treatment where appropriate and a primary efficacy end‐point defined as the absence of live head lice.
Results: A total of 216 children were enrolled. One hundred and sixty‐nine were per‐protocol. The suffocant was significantly more effective than malathion for the intention‐to‐treat population (53.9% vs 40.4% louse‐free, unadjusted P = 0.052; adjusted P = 0.024), as well as for the per‐protocol population (57.8% vs 43.0% louse‐free, unadjusted P = 0.054; adjusted P = 0.045). Adverse events were limited to itching or stinging and there were no serious or systemic adverse events. Repeat insult patch testing with the suffocant resulted in no adverse reactions. In vitro tests confirmed that the suffocant is a potent ovicide and pediculicide with 100% mortality of eggs and lice following a 20‐min contact time.
Conclusions: The suffocant is shown to be significantly more effective in eliminating head lice than malathion in children, while being associated with a low incidence of mild, transient adverse events.</abstract><cop>Melbourne, Australia</cop><pub>Blackwell Publishing Asia</pub><pmid>20695855</pmid><doi>10.1111/j.1440-0960.2010.00622.x</doi><tpages>8</tpages></addata></record> |
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| ispartof | Australasian journal of dermatology, 2010-08, Vol.51 (3), p.175-182 |
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| subjects | Adult Aged Animals Antibiotics. Antiinfectious agents. Antiparasitic agents Antiparasitic agents Asphyxia - chemically induced Biological and medical sciences Child Child, Preschool children clinical trial Dermatology Exanthema - chemically induced Female General aspects head lice Humans Insecticides - therapeutic use Lice Infestations - drug therapy malathion Malathion - adverse effects Malathion - therapeutic use Male Medical sciences Middle Aged Pediculus - drug effects Pharmacology. Drug treatments resistance Scalp - drug effects Single-Blind Method suffocation Treatment Outcome Young Adult |
| title | A randomized, assessor-blind, parallel-group, multicentre, phase IV comparative trial of a suffocant compared with malathion in the treatment of head lice in children |
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