Head louse infection
Conditions
Interventions
Product Name: KindaPed
Product Code: C1845
Pharmaceutical Form: Cutaneous liquid
CAS Number: 1117-86-8
Current Sponsor code: XHFZ01
Sponsors
EctoPharma Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged four and over. Patients who upon examination, are confirmed to have live head lice. Patients who have given written informed consent, or if the patient is less than 16 years of age whose parent/guardian gives written informed consent to participate in the study. Patients who will be available for home visits from MEC study team members over the fifteen days of the study. 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: Patients with a known sensitivity to any of the ingredients in the product. Patients 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). Patients known to suffer from asthma. Patients who have been treated with other head lice products within the last two weeks. There must be a 14 day gap since treatment for head lice was last used before the patient can be accepted on to this trial. Patients 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). Patients who have been treated with the antibiotics Co-Trimoxazole, Septrin or Trimethoprim within the last four weeks, or who are currently taking such a course. Pregnant or nursing mothers. Patients who have participated in another clinical study within 1 month before entry to this study. Patients who have already participated in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of KindaPed to cure head louse infection.;Primary end point(s): The number of participants satisfying the criteria for cure or re-infestation as defined in the protocol (section 3.1.2). These participants will all be cured of the infestation evident at Day 0.; Secondary Objective: To assess the efficacy of KindaPed to kill head lice. To evaluate the efficacy of KindaPed to kill louse eggs. To monitor the safety and acceptability of KindaPed in clinical use. To assess the ease of application of KindaPed. To assess the total treatment dose for each participant, and to calculate an average dose level for this product. | — |
Countries
United Kingdom
Outcome results
None listed