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A highly efficacious pediculicide based on dimeticone: randomized observer blinded comparative trial.

Heukelbach J, Pilger D, Oliveira FA, Khakban A, Ariza L, Feldmeier H - BMC Infect. Dis. (2008)

Bottom Line: 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).The dimeticone product is a safe and highly efficacious pediculicide.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Community Health, School of Medicine, Federal University of CearĂ¡, Fortaleza, Brazil. heukelbach@web.de

ABSTRACT

Background: Infestation 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(R)), as compared to a 1% permethrin lotion.

Methods: Randomized, 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.

Results: Overall 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.

Conclusion: The 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 registration: Current Controlled Trials ISRCTN15117709.

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Assessment of degree of itching using an ordinal visual scale ranging from 0 to 4.
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Figure 1: Assessment of degree of itching using an ordinal visual scale ranging from 0 to 4.

Mentions: Secondary outcomes included the reduction of clinical pathology, reduction of the degree of itching, cosmetic acceptability of the products, and safety (number and type of adverse events). The degree of itching was assessed daily based on a pre-tested ordinal visual analogue scale ranging from 0 to 4 (Figure 1). Cosmetic acceptability was assessed using a summary score ranging from -4 (extremely negative) to +4 (extremely positive), using a standardized questionnaire including subjective assessment of smelling, irritation of scalp, cosmetic changes of hair, and changes in the easiness to comb the hair. Clinical pathology included the presence of erythema, papules, excoriations, eczema, secondary infection and enlarged cervical or retro-auricular lymph nodes.


A highly efficacious pediculicide based on dimeticone: randomized observer blinded comparative trial.

Heukelbach J, Pilger D, Oliveira FA, Khakban A, Ariza L, Feldmeier H - BMC Infect. Dis. (2008)

Assessment of degree of itching using an ordinal visual scale ranging from 0 to 4.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2553415&req=5

Figure 1: Assessment of degree of itching using an ordinal visual scale ranging from 0 to 4.
Mentions: Secondary outcomes included the reduction of clinical pathology, reduction of the degree of itching, cosmetic acceptability of the products, and safety (number and type of adverse events). The degree of itching was assessed daily based on a pre-tested ordinal visual analogue scale ranging from 0 to 4 (Figure 1). Cosmetic acceptability was assessed using a summary score ranging from -4 (extremely negative) to +4 (extremely positive), using a standardized questionnaire including subjective assessment of smelling, irritation of scalp, cosmetic changes of hair, and changes in the easiness to comb the hair. Clinical pathology included the presence of erythema, papules, excoriations, eczema, secondary infection and enlarged cervical or retro-auricular lymph nodes.

Bottom Line: 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).The dimeticone product is a safe and highly efficacious pediculicide.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Community Health, School of Medicine, Federal University of CearĂ¡, Fortaleza, Brazil. heukelbach@web.de

ABSTRACT

Background: Infestation 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(R)), as compared to a 1% permethrin lotion.

Methods: Randomized, 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.

Results: Overall 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.

Conclusion: The 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 registration: Current Controlled Trials ISRCTN15117709.

Show MeSH
Related in: MedlinePlus