Head louse infection MedDRA version: 9.1 Level: LLT Classification code 10019197 Term: Head lice
Conditions
Interventions
Product Name: KindaPed
Pharmaceutical Form: Cutaneous liquid
CAS Number: 1117-86-8
Other descriptive name: 1,2 octanediol
Concentration unit: % (W/V) percent weight/volume
Concentration type: equal
Co
Sponsors
EctoPharma Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for the trial all of the following criteria must be fulfilled: 1. Subjects aged four or over. 2. Subjects who upon examination are confirmed to have live head lice. 3. Subjects who have given written informed consent, or, if the subject is less than 16 years of age, whose parent/guardian has given written informed consent to participate in the study. 4. Subjects who will be available for home visits from research staff over the 15 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: The subject is not eligible to participate in the trial in any of the following circumstances. 1. Subjects with a known sensitivity to any of the ingredients in the products. 2. Subjects 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). 3. Subjects currently on prescribed medication for the prophylaxis or treatment of asthma. [‘Currently’ will be interpreted as meaning that the subject has used asthma medication within the previous four months.] 4. Subjects who have been treated with other head lice products within the last two weeks. There must have been a 14-day gap since treatment for head lice was last used before the subject can be accepted into this trial. 5. Subjects 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). 6. Subjects who have been treated with the antibiotics Co-Trimoxazole, Septrin or Trimethoprim within the previous four weeks, or who are currently taking such a course. 7. Pregnant or nursing mothers. 8. Subjects who have participated in another clinical trial within one month prior to entry to this study. 9. Subjects who have already participated in this clinical study or any clinical study of KindaPed™.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the clinical trial is to compare the efficacy of each of two different application regimens (2-hour and 8-hour) of KindaPed™ with the standard regimen of Derbac-M Liquid in eliminating infestation (achieving cure or re-infestation) following two treatment applications. ;Primary end point(s): The primary endpoint is the proportion of subjects satisfying the criteria for cure or re-infestation as defined by the treatment outcome algorithm. These subjects will all have been cured of the infestation evident at Day 0.;Secondary Objective: The secondary objectives of the clinical trial include the comparison of each of two different application regimens of KindaPed™ with the standard regimen of Derbac-M Liquid in respect of the following: • Efficacy in achieving ‘cure’, based only on the assessments at Days 2 and 6, following the first treatment application. • Efficacy in killing head lice after two applications. • Efficacy in killing louse eggs after two applications. • Safety profile, as determined by the occurrence of adverse events. • Ease of application. • Subject assessment of acceptability. | — |
Countries
United Kingdom
Outcome results
None listed