Treatment of head louse infection Infections and Infestations Head louse infection
Conditions
Interventions
The participants hair will be combed with a fine toothed comb at the start of the study and on a further five occasions in order to assess the level of head lice infection. The study treatment will be
Sponsors
EctoPharma Ltd (UK)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects aged four and over 2. Subjects who upon examination are confirmed to have live head lice 3. Subjects who have given written informed consent, or, if the subject is less than 16 years of age, whose parent/guardian has given written informed consent to participate in the study 4. Subjects who will be available for home visits from research staff over the 15 days of the study
Exclusion criteria
Exclusion criteria: 1. Subjects with a known sensitivity to any of the ingredients in the products 2. Subjects 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) 3. Subjects currently on prescribed medication for the prophylaxis or treatment of asthma (?currently? will be interpreted as meaning that the subject has used asthma medication within the previous four months) 4. Subjects who have been treated with other head lice products within the last two weeks. There must have been a 14-day gap since treatment for head lice was last used before the subject can be accepted into this trial 5. Subjects who have bleached hair, or hair that has been colour treated or permanently waved within the last four weeks (wash in/wash out colours are acceptable) 6. Subjects who have been treated with the antibiotics Co-Trimoxazole, Septrin or Trimethoprim within the previous four weeks, or who are currently taking such a course 7. Pregnant or nursing mothers 8. Subjects who have participated in another clinical trial within one month prior to entry to this study 9. Subjects who have already participated in this clinical study or any clinical study of KindaPed™
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of subjects satisfying the criteria for cure or re-infestation as defined by the treatment outcome algorithm. These subjects will all have been cured of the infestation evident at Day 0. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary measures will be: 1. The proportion of subjects satisfying the criteria for cure based only on the assessments at Days 2and 6 following the first treatment application 2. The proportion of subjects satisfying the criteria for killing lice following two treatment applications 3. The proportion of subjects satisfying the criteria for killing eggs following two treatment applications 4. The safety of the study products, as determined by the occurrence of adverse events 5. Ease of application of the study products as assessed by an investigator questionnaire 6. Subject assessment of acceptability | — |
Countries
United Kingdom
Outcome results
None listed