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| [ Print-friendly version ] |
| Does Lyclear® spray away work better than permethrin to cure head lice? |
| ISRCTN | ISRCTN96469780 |
| ClinicalTrials.gov identifier | |
| Public title | Does Lyclear® spray away work better than permethrin to cure head lice? |
| Scientific title | A randomised, controlled, assessor-blind, clinical trial to investigate superiority of Lyclear® spray away (ParaNix® spray) compared with Infectopedicul® permethrin 0.5% lotion in the treatment of head lice |
| Acronym | N/A |
| Serial number at source | CTOM01, version 1.3 (18/02/2008) |
| Study hypothesis | To investigate superiority of Lyclear® spray away (ParaNix® spray) over Infectopedicul® in the eradication of head lice and prevention of hatching of louse eggs and to compare the products for safety, ease of application and participant acceptability. |
| Ethics approval | Leeds (West) Research Ethics Committee. Date of approval: 04/03/2008 (ref: 08/H1307/18) |
| Study design | Randomised, controlled, assessor blind, parallel group study. |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Infestation with head lice (Pediculus capitis) |
| Participants - inclusion criteria |
1. Both males and females, aged 2 years and over with no upper age limit
2. Participants who upon examination, are confirmed to have live head lice 3. Participants who give written informed consent, or if the participant is under 16 years of age whose parent/guardian gives written informed consent to participate in the study 4. Participants who will be available for home visits by Medical Entomology Centre (MEC) study team members over the 14 days following first treatment |
| Participants - exclusion criteria |
1. Participants with a known sensitivity to any of the ingredients in Lyclear® spray away (ParaNix® spray) or Infectopedicul® lotion
2. Participants with asthma or a similar respiratory condition 3. Participants with a secondary bacterial infection of the scalp (e.g. impetigo) or who have a long term scalp condition (e.g. psoriasis of the scalp) 4. Participants who have been treated with other head lice products within the previous two weeks 5. Participants who have bleached hair, or hair that has been colour treated or permanently waved within the previous four weeks (wash in/wash out colours are acceptable) 6. Participants who have been treated with the antibiotics co-trimoxazole or trimethoprim within the previous four weeks, or who are currently taking such a course 7. Pregnant or nursing mothers 8. Participants who have participated in another clinical study within 1 month before entry to this study 9. Participants who have already participated in this clinical study |
| Anticipated start date | 23/03/2008 |
| Anticipated end date | 31/05/2008 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 100 |
| Interventions |
The participants will be randomly allocated to the two groups in equal numbers.
Group 1: Participants will be treated with Lyclear® spray away (ParaNix® spray; topical) containing: Active: Illicium verum (star anise) oil, caprylic/capric triglyceride (fractionated coconut oil derivative), cananga odorata (ylang-ylang) oil Excipients: Propan-2-ol Group 2: Participants will be treated with Infectopedicul® lotion (topical) containing: Active: 0.5% permethrin Excipients: Ethanol, propanol-2-ol, water, propylene glycol, sodium hydrogen phosphate The total duration of intervention and follow-up for each participant is 15 days, two treatments 9 days apart with a follow-up 2 and 7 days after the first treatment and 2 and 5 days after the second treatment. |
| Primary outcome measure(s) |
1. Number of participants with no evidence of active head louse infestation 14 days (+/- 1 day) after enrolment
2. Safety, assessed 2 and 7 days after the first treatment, and 2 and 5 days after the second treatment |
| Secondary outcome measure(s) |
1. Ease of application (investigator opinion), assessed using a questionnaire on the same day as the first treatment
2. Participant acceptability, assessed using a questionnaire 5 days after the second treatment |
| Sources of funding | Omega Pharma N.V. (Belgium) |
| Trial website | |
| Publications | 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19343362 |
| Contact name | Mr Ian Burgess |
| Address |
Medical Entomology Centre
Insect Research & Development Limited Cambridge House Barrington Road Shepreth |
| City/town | Royston |
| Zip/Postcode | SG8 6QZ |
| Country | United Kingdom |
| Tel | +44 1763 263011 |
| Fax | +44 1763 263022 |
| ian@insectresearch.com | |
| Sponsor | Omega Pharma N.V. (Belgium) |
| Address | Venecoweg 26 |
| City/town | Nazareth |
| Zip/Postcode | B-9810 |
| Country | Belgium |
| Sponsor website: | http://www.omega-pharma.be |
| Date applied | 07/04/2008 |
| Last edited | 26/11/2009 |
| Date ISRCTN assigned | 29/05/2008 |
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