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Randomised, controlled, parallel group clinical trials to evaluate the efficacy of isopropyl myristate/cyclomethicone solution

To evaluate the efficacy and safety of two applications, seven daysapart, of either isopropyl myristate/cyclomethicone solution (IPM/C)(Full Marks Solution) or permethrin 1% (Lyclear Creme Rinse) for thetreatment of head louse infestation. Head louse infestation is commonin the community, with school-aged children being the most frequentlyaffected

By Ian F. Burgess, Peter N. Lee and Christine M. Brown

Ian F. Burgess, MPhil, FRES, is director and Christine M. Brown, RGN, SN Cert, is trial co-ordinator/lead investigator at the Medical Entomology Centre, Insect Research & Development Ltd, Royston. Peter N. Lee, MA, is statistician at P. N. Lee Statistics and Computing Ltd, Surrey.

Correspondence to: Ian Burgess, Medical Entomology Centre, Insect Research & Development Ltd, Cambridge House, Barrington Road, Shepreth, Royston SG8 6QZ (e-mail: ian@insectresearch.com).

Abstract

Aim

To evaluate the efficacy and safety of two applications, seven days apart, of either isopropyl myristate/cyclomethicone solution (IPM/C) (Full Marks Solution) or permethrin 1% (Lyclear Creme Rinse) for the treatment of head louse infestation.

Design

Two assessor-blind, randomised, controlled, parallel group, clinical trials.

Subjects and setting

Community based with home visits involving 168 participants (141 children aged 1 to 17, and 27 adults) with active head louse infestation.   

Outcome measures

Treatment success was defined as cure of infestation (ie, no evidence of head lice after the second treatment) or reinfestation after cure.

Results

Cure (or reinfestation after cure) occurred in 82.0% (91/111) of participants treated with IPM/C and 19.3% (11/57) of participants treated with permethrin 1% (P<0.001, difference 62.7%, 95% confidence interval 50.2% to 75.2%). IPM/C was found to be easier to apply to the hair and scalp (P<0.001), and had less odour (P<0.001). There was no significant difference between the products in terms of frequency or nature of adverse events.

Conclusion

IPM/C cures head louse infestation with a
10-minute contact time. It has a physical action that kills head lice that should not be affected by resistance to neurotoxic insecticides. 

Citation: The Pharmaceutical Journal URI: 10967949

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