Infestation by head lice (pediculosis capitis) MedDRA version: 9.1 Level: LLT Classification code 10019199 Term: Head pediculosis
Conditions
Interventions
Trade Name: Infectopedicul lotion
Pharmaceutical Form: Cutaneous solution
INN or Proposed INN: permethrin
CAS Number: 52645-53-1
Current Sponsor code: permethrin
Concentration unit: % (W/V) percent we
Sponsors
Omega Pharma N.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants aged 2 years and over with no upper age limit. Participants who upon examination, are confirmed to have live head lice. Participants who give written informed consent, or if the participant is under 16 years of age whose parent/guardian gives written informed consent to participate in the study. Participants who will be available for home visits by MEC study team members over the 14 days following first treatment. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Participants with a known sensitivity to any of the ingredients in Lyclear spray away (ParaNix spray) or Infectopedicul lotion. Participants with asthma or a similar respiratory condition. Participants 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). Participants who have been treated with other head lice products within the previous two weeks. Participants who have bleached hair, or hair that has been colour treated or permanently waved within the previous four weeks (wash in/wash out colours are acceptable). Participants who have been treated with the antibiotics Co-Trimoxazole or Trimethoprim within the previous four weeks, or who are currently taking such a course. Pregnant or nursing mothers. Participants who have participated in another clinical study within 1 month before entry to this study. Participants who have already participated in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate superiority of efficacy of Lyclear spray away (ParaNix spray) [a class I medical device] over Infectopedicul lotion [a medicinal product] in the eradication of head lice and prevention of hatching of louse eggs.;Secondary Objective: To compare Lyclear spray away (ParaNix spray) with Infectopedicul lotion with regard to safety, ease of application and participant acceptability;Primary end point(s): The primary measure is the between treatment comparison of the number of participants with no evidence of active head louse infestation 14 days (+/- 1 day) after enrolment. | — |
Countries
United Kingdom
Outcome results
None listed