Invstigating the local managment of insect bites

Conditions: Inflamatory reaction to a mosquito bite
Therapeutic area: Body processes [G] - Integumentary System Physiological Phenomena [G13]

Registration Number: EUCTR2011-004610-42-GB

Lead Sponsor: ondon School of Hygiene and Tropical Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
;
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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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.
;
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.