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 the non-inferiority of mosquito® LäuseShampoo in comparison with Infectopedicul® lotion in the eradication of head louse infestation. |
|
E.2.2 | Secondary objectives of the trial |
If there is sufficient margin in efficacy to detect superiority of efficacy of mosquito® LäuseShampoo over Infectopedicul® lotion in the eradication of head louse infestation.
To compare mosquito® LäuseShampoo 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 |
1. Participants aged 2 years and over with no upper age limit.
2. Participants who upon examination, are confirmed to have at least five live head lice.
3. Participants who give written informed consent, or if the participant is below 16 years of age whose parent/guardian gives written informed consent to participate in the study.
4. 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 |
1. People younger than 2 years
2. People with a known sensitivity to pyrethroid insecticides like permethrin, chrysanthemums, nuts, soya, or any of the ingredients in mosquito® LäuseShampoo or Infectopedicul® lotion.
3. People with asthma or a similar respiratory condition.
4. People 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).
5. People who have been treated with other head lice products within the previous two weeks.
6. People who have been treated with the antibiotics Co-Trimoxazole, Trimethoprim or any other medical treatment which could interfere with the study treatment within the previous four weeks, or who are currently taking such a course.
7. People who have bleached, permanently coloured, or permanent waved their hair within the previous four weeks.
8. People or parents / guardians not giving written consent or withdrawal of the written consent.
9. Pregnant or nursing mothers. Any potential participant in menses should confirm that they are not or not likely to be pregnant or are taking an appropriate form of contraception. In case of doubt a urine pregnancy test may be performed prior to entry.
10. People who have participated in another clinical study within 1 month before entry to this study.
11. People who have already participated in this clinical study. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To investigate the non-inferiority of mosquito® LäuseShampoo in comparison with Infectopedicul® lotion in the eradication of head louse infestation. |
|
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 | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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
|
The study may be terminated at any time if the recruitment rate is such that the required number of participants will not be recruited within the specified time, if the products being used are deemed to be failing unacceptably, or if any safety concerns arise. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 4 |