E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Head louse infestation (pediculosis capitis) |
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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 | 10034214 |
E.1.2 | Term | Pediculus capitis (head louse) |
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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 activity of Hedrin 4% lotion with regard to elimination of infestation by head lice using a 1 hour application time. |
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E.2.2 | Secondary objectives of the trial |
1. To investigate the activity of Hedrin 4% lotion with regard to prevention of louse egg hatching (ovicidal action) by monitoring the presence/absence of juvenile stages of lice following the first treatment using a 1 hour application.
2. To investigate Hedrin 4% lotion with regard to safety, ease of application and participant acceptability using a 1 hour application.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Participants aged 6 months and over with no upper age limit.
2. Participants who upon examination, are confirmed to have live head lice.
3. 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.
4. Participants who will be available for follow up visits by study team members over the 14 days following first treatment.
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E.4 | Principal exclusion criteria |
1. Participants with a known sensitivity to any of the ingredients in Hedrin 4% lotion.
2. Participants with a secondary bacterial infection of the scalp (e.g. impetigo) or who have an active long term scalp condition (e.g. psoriasis of the scalp).
3. Participants who have been treated with other head lice products within the previous two weeks.
4. Participants who have bleached hair, or hair that has been permanently waved within the previous four weeks.
5. 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.
6. Pregnant or nursing mothers.
7. Participants who have participated in another clinical study within 1 month before entry to this study.
8. Participants who have already participated in this clinical study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary measure is elimination of head lice following the second application of product by checks on days 9 and 14 of the study. |
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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 | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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
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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 | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 3 |