Head louse infestation (pediculosis capitis) Infections and Infestations Head louse infestation
Conditions
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
Sponsors
Nelsons (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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 breastfeeding 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 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. 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
| Measure | Time frame |
|---|---|
| Safety and acceptability of the Nice ?n Clear preparations and Full Marks solution, measured at the end of the 15 days | — |
Countries
United Kingdom
Outcome results
None listed