E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Infestation by head lice (pediculosis capitis) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019199 |
E.1.2 | Term | Head pediculosis |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
|
E.2.2 | Secondary objectives of the trial |
To compare Lyclear spray away (ParaNix spray) with Infectopedicul lotion with regard to safety, ease of application and participant acceptability |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |