Pediculus capitis (headlice) infestation within a household group living under the same roof. Infections and Infestations
Conditions
Interventions
Following confirmation of index case(s) within a household group, the index case(s) will be treated with a headlice treatment with known efficacy (Vamousse® Mousse). Households will then be randomised
Sponsors
Alliance Pharmaceuticals (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females, minimum age 4 years, with no upper age limit who are family members of an eligible index case (as defined below). 2. People who upon examination, are confirmed to have an active infestation with head lice, as shown by presence of at least one live louse on Day 0 are eligible as index cases. For the purposes of randomisation, only the first presenting case in a household shall be considered a Primary index case. 3. People who give written informed consent or, if the prospective participant is under 16 years of age, whose parent/guardian gives written informed consent to participate in the study. 4. People who will be available for home visits by MEC study team members over the 15 days of the study. 5. Primary Index cases should preferably be children between the ages of 5 & 11 years but not adults, although adults may be secondary index cases, and must have at least one sibling of similar age, with at least one responsible adult living under the same roof.
Exclusion criteria
Exclusion criteria: 1. Anyone with a known sensitivity to any of the ingredients in Vamousse Lice Defence Shampoo, or The Control Shampoo. 2. Anyone with a secondary bacterial infection of the scalp (e.g. impetigo) or who has a long-term scalp condition (e.g. psoriasis of the scalp). 3. Anyone who has used treatment for head lice infestation within the previous 7 days. 4. Anyone who has been treated using a trimethoprim-based antibiotic product during the past 4 weeks or who is currently under such treatment. 5. Pregnant or breast-feeding mothers. 6. Anyone who has participated in another clinical study within 1 month before entry to this study. 7. Anyone who has already participated in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects in each household with live lice or nymphs at day 14 measured by thorough detection combing by the investigator team | — |
Secondary
| Measure | Time frame |
|---|---|
| Cosmetic acceptability of the shampoo, collected by participant diary entries throughout the study period | — |
Countries
England, United Kingdom
Outcome results
None listed