Prevention of infestation with Pediculus humanus capitis in the family group using a pediculicidal shampoo: A prospective, randomised controlled study.

Alliance Pharmaceuticals (United Kingdom)0 sites84 target enrollmentFebruary 25, 2022

Overview

Phase: 未知
Intervention: Not specified
Conditions: Pediculus capitis (headlice) infestation within a household group living under the same roof.
Sponsor: Alliance Pharmaceuticals (United Kingdom)
Enrollment: 84
Status: Completed
Last Updated: last year

No summary available.

Registry

who.int

Start Date

February 25, 2022

End Date

April 30, 2023

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Alliance Pharmaceuticals (United Kingdom)

•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.

•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.