Vamousse® shampoo to prevent the spread of headlice to other people living in the same household

Not Applicable

Completed

Conditions: Pediculus capitis (headlice) infestation within a household group living under the same roof.
Infections and Infestations

Registration Number: ISRCTN50658447

Lead Sponsor: Alliance Pharmaceuticals (United Kingdom)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 84

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

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.