E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
This is a randomized, double-blind, placebo-controlled clinical study on efficacy of Diffusil H Forte spray in people with pediculosis. |
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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 | 10034208 |
E.1.2 | Term | Pediculosis |
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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 demonstrate the superiority of Diffusil H Forte spray over a placebo in pediculosis treatment after two applications 9 days apart. |
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E.2.2 | Secondary objectives of the trial |
1)To determine the clinical efficacy of Diffusil H Forte spray in pediculosis treatment under the conditions of this clinical trial. 2)To evaluate the safety and tolerance of Diffusil H Forte spray in pediculosis treatment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
a)patients with pediculosis confirmed by a positive dry combing test at Visit 1 b)patients able and willing to give written informed consent c)patients able and willing to comply with the requirements of the study protocol d)feasibility of the dry combing test e)age 18- 70 years, male and female
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E.4 | Principal exclusion criteria |
a)any scalp condition that makes impossible the feasibility of the dry combing test b)acute conjunctivitis c)clinical signs of eczema exacerbation d)contact eczema in anamnesis e)history of severe allergic or anaphylactic reactions to any ingredients of the tested products f)history of sensitivity to hair shampoo and conditioners g)previous treatment with anti-lice products 2 weeks prior to Visit 1 h)concomitant treatment influencing the evaluation of efficacy such as use of trimethoprim or cotrimoxazol within 4 weeks prior to Visit 1 i)use of antihistaminics within 3 days prior Visit 1 j)participating in another clinical trial within 4 weeks prior to Visit 1 k)pregnancy or breast-feeding l)hairdressing such as bleaches, perm or dying
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E.5 End points |
E.5.1 | Primary end point(s) |
The efficacy parameter defined as the cure rate after the treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 9 |
E.8.9.1 | In the Member State concerned days | |