E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The degree of pain reduction in test subjects using a specific jellyfish (cnidaria) sting inhibitor and repellent lotion, compared to control subjects being protected by a normal water repellent sunscreen or no sun lotion at all. The jellyfish exposed skin parts will be treated for pain relief with hot or cold therapy or a commercially available local pain relief product (xylocain) from pharmacy. |
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MedDRA Classification |
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 |
The purpose of the study is to investigate the effectiveness of a sun lotion containing a specific Jellyfish sting inhibitor versus regular sun lotions as controls. |
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E.2.2 | Secondary objectives of the trial |
Investigate the effectiveness of hot/cold immersion for the treatment of Jellyfish (Cyanea sp) stings versus local pain relief with prescription free pharmaceutical drugs. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Healthy subjects over 18 years. The subjects can be of both sexes. |
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E.4 | Principal exclusion criteria |
Subjects with a history of certain sorts of allergic reactions are being excluded to minimize any possible risk. Subjects with a history of unusual adverse reaction to insects, jellyfish, or other types of stings will be excluded.
• People with atopic diseases, e.g., asthma, allergic rhinorrhea or rhinitis, hay fever, or atopic skin inflammation • Pregnancy. • People who suffer from skin diseases in the testing regions or whose inner forearms are too hairy to allow for interpretation of the test • People who have used any medical or cosmetic product on either arm for 48 hours before the start of the experiment • People who are taking antihistamines or steroids • Subjects with medical conditions which, in the opinion of the investigator, pose risks that would prohibit participating • Subjects with a history of keloid formation will be excluded from the Jellyfish protocol • Subjects with allergy to lidocain or other local pain substances
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome is a clinically important reduction in pain as measured by the visual analogue scale (VAS). Secondary outcomes is to count the number of nematocyst fired when use of protection versus no protection. |
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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 | No |
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 | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Hot or cold immersion of the affected body part. |
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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 | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 1 |