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| A new treatment for head lice? Efficacy of Nice 'n Clear and 'ClearBrush' for nit removal |
| Source of record | UK Trials |
| ISRCTN | ISRCTN77673809 |
| Date ISRCTN assigned | 05/02/2008 |
| Local reference number(s) | Protocol CTNC02, Version: 1.0, 20 February 2007 |
| Public title | A new treatment for head lice? Efficacy of Nice 'n Clear and 'ClearBrush' for nit removal |
| Scientific title | A randomised, assessor blinded clinical study to compare the efficacy and safety of Nice 'n Clear with Full Marks solution and to evaluate a novel ultrasound comb device 'ClearBrush' for removal of nits |
| Acronym | ClearBrush |
| Disease/condition/study domain | Head louse infestation (pediculosis capitis) |
| Study hypothesis | This study has two elements, in the first a comparison will be made of the silicone based Nice 'n Clear with that of Full Marks solution. At the same time ClearBrush will be evaluated for efficacy at removing louse eggs and nits using both new formulation of Nice 'n Clear and the original formulation. The data obtained from the comparison of Nice 'n Clear with Full Marks solution and the data obtained in the earlier CTNC01 study will be used as baseline data for comparing the efficacy of ClearBrush to facilitate louse egg removal using each of these lubricants. Safety, ease of application, and participant acceptability of each of the products will also be assessed. |
| Design/methodology | Randomised, single blind (assessor blind), parallel group, comparative, multicentre study. |
| Research ethics review | Ethics approval received from the Cambridgeshire 1 Research Ethics Committee on the 20th June 2007 (ref: 07/Q0104/44). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Male and female participants who are found to have an active head louse infection, i.e. the presence of live lice. Detection combing will be done with a fine-toothed plastic detection comb, until at least one louse is found. Any lice found at these assessments will not be removed. 2. Participants who give written informed consent and/or, if the participant is below 16 years of age, whose guardian gives written informed consent to participate in the study. An assent form will be required for those between the ages of 4 and 16 years of age. There is no maximum age limit. The lower age limit for this study will be 2 years (Nice 'n Clear is marketed as a medical device for babies and children down to the age of 6 months and Full Marks solution for children down to 2 years). 3. Participants must be available for the duration of the study, i.e., 15 days |
| Participants - exclusion criteria | 1. Participants who have been treated with other head louse products within the previous 2 weeks (14 days) 2. Participants who have undergone a course of antibiotic treatment using Cotrimoxazole, Trimethoprim or Septrin within the previous 4 weeks, or who are currently taking such a course 3. Participants whose hair has been bleached, colour treated, or semi-permanently waved within the previous 2 weeks, this includes the use of semi-permanent colouring agents. Home use wash in/wash out colouring agents are acceptable. 4. Participants who have taken part in another clinical study within 4 weeks prior to entry to this one 5. Female participants who are pregnant or breast-feeding 6. Participants who have already taken part in this study 7. Participants who have a known allergy to any of the ingredients of either of the Nice 'n Clear preparations or Full Marks solution (including allergy to Paraben preservatives) 8. Children under 2 years of age |
| Patient information material | |
| Anticipated start date | 13/09/2007 |
| Anticipated end date | 31/12/2007 |
| Status of trial | Completed |
| Target number of participants | 176 |
| Interventions | 1. Herbal based (neem oil, with tea tree, thyme and lemongrass essential oils) lotion in a silicone vehicle (reformulated Nice 'n Clear lotion) (66 participants) 2. Isopropyl myristate/cyclomethicone lotion (Full Marks solution) (66 participants) 3. ClearBrush ultrasound nit removing comb in combination with herbal based lotion in an aqueous cream vehicle (original Nice 'n Clear head louse treatment lotion) (22 participants) 4. ClearBrush ultrasound nit removing comb in combination with herbal based lotion in a silicone vehicle (reformulated Nice 'n Clear lotion) (22 participants) The total time for intervention and follow up for each participant is 15 days, two treatments a week apart with a follow-up 2 and 6 days after the first treatment and 2 and 7 days after the second treatment. |
| Primary outcome measure(s) | 1. To evaluate the efficacy of using reformulated Nice 'n Clear lotion in comparison with Full Marks solution to cure an infection, i.e. no lice at the days 9 and 14 assessments 2. To evaluate the efficacy of the ClearBrush in use with the new and the original Nice 'n Clear head lice treatment preparations, measured using data obtained from each treatment, i.e. on days 7 and 14 |
| Secondary outcome measure(s) | To compare the safety and acceptability of the Nice ¿n Clear preparations and Full Marks solution, measured at the end of the 15 days. |
| Sources of funding | European Commission (Belgium) - 6th Framework Programme: horizontal research activities involving SMES co-operative research (contract number: 017916-ClearBrush) |
| Sponsor name | Nelsons (UK) |
| Sponsor details | Nelsons House 83 Parkside Wimbledon London United Kingdom SW19 5LP |
| Sponsor website | http://www.nelsons.net/corporate_home |
| Contact name | Mr Ian Burgess |
| Contact details | Medical Entomology Centre Insect Research & Development Limited Cambridge House Barrington Road Shepreth Royston United Kingdom SG8 6QZ |
| Contact telephone | +44 (0)1763 263011 |
| Contact fax | +44 (0)1763 263022 |
| Contact email | ian@insectresearch.com |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN77673809 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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