E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Inflamatory reaction to a mosquito bite |
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E.1.1.2 | Therapeutic area | Body processes [G] - Integumentary System Physiological Phenomena [G13] |
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 |
Evaluate two separate anti inflammatory products for the relief of symptoms through suppression of the immunological and inflammatory response following a mosquito bite. We have selected ibuprofen gel as a NSAI formulation and 0.05% Clobetasone butyrate as a steroid cream with their appropriate physical matched placebo products. |
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E.2.2 | Secondary objectives of the trial |
The effect of optimal treatment (determined by the first study) in the suppression of symptoms when applied 4 hours after receiving a mosquito bite. The likely application of these agents in real life would be some hours after the bite and therefore the later application is a better representation of the likely use of the agent. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
18 to 65 years of age (inclusive). Caucasian (white or pale skin) Good health as determined by medical history and physical examination Females of child bearing potential ?must have a negative pregnancy test / must confirm they are not pregnant at the study start and agree not to become pregnant throughout the duration of the study. . History of the following triad of symptoms following a previous mosquito bite: weal, flare, and pruritus as immediate reaction to mosquito bites at least once in the past (= mosquito bite sensitive stages III or IV). Willingness to attend for all study procedures at designated intervals. Willingness to provide full consent to the study |
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E.4 | Principal exclusion criteria |
Abnormalities of the skin on the forearms (including sunburn) that might interfere with the study results, as determined by the investigator/clinician during physical inspection. History of clinically significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, metabolic, or other disease deemed clinically significant by investigator / clinician Use of prohibited therapies (including cosmetics on either forearm) as specified in Section 6.3.3 of the Clinical Trial Protocol (use of systemic or local antihistamines, steroids, or NSAIDs during or within 2 weeks prior to planned date of first study procedure); use of any medication considered to have an influence on the outcome of the study. Any acute illness within the 7 days prior to planned date of first study procedure which might interfere with the study results (as determined by the investigator/clinician from medical history). History of malignancy within 5 years of the planned date of the first study procedure Neurological or psychiatric disease, or drug or alcohol abuse which would interfere with the subject's completion of the protocol assignments. Participated in research involving an investigational drug within 3 months of the planned date of first study procedure. History of known anaphylactic hypersensitivity to mosquitoes bites, bee or wasp stings. History of allergic reaction to any of the topical agents used in the study or any of their components. History of allergy to latex or other rubber material Women who are pregnant or breastfeeding history of recent travel to a region where mosquito borne disease are present. 13) Safety concerns: 14) History of hypersensitivity to stings of mosquitoes, bees, or wasps. 15) History of allergic reaction to the trial medication or its ingredients. 16) History of allergy to Latex or other rubber materials. 17) Lactating female or female of child-bearing potential not using adequate contraception. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The statistical difference between active and placebo agent on bite reaction measured as size of wheal, flare in mm and itching measured on a visual scale recorded by the subject. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Measurements will be made at baseline 5, 15, 30, 60 and 90 minutes following the baseline measurement. |
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E.5.2 | Secondary end point(s) |
Paind and itching measured on a visual scale |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1, 5, 15, 30, 45, 60, and 90 minutes |
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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 | No |
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 | No |
E.8.1.4 | Double blind | Yes |
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) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | No |
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 | 2 |
E.8.9.1 | In the Member State concerned days | 1 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 1 |