Controlled study to investigate the efficacy of the insect bite healer BR 60 against pruritus and swelling after mosquito bites (MüPruritus)

Not Applicable

Not yet recruiting

• Conditions: T13.03

• Registration Number: DRKS00033004
• Lead Sponsor: Institut Kurscheid

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Consent to the study
- >18 years
- Knowledge of own reaction to insect bites
- Willingness to be bitten twice by the two mosquito strains
laboratory strains

Exclusion Criteria

- Allergies to insect bites
- Acute skin diseases in the region
- Acute illnesses (especially with a tendency to thromboembolic diseases and malignant neoplasms)
- Chronic pain conditions that have not been clarified, regardless of the body region
- Diabetes
- Sensitivity disorder with reduced pain sensation (e.g. metabolic disorder)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in pruritus severity between treated and untreated prick on a 10-point VAS score over 1 hour (AUC)

Secondary Outcome Measures

Name	Time	Method
Difference in pruritus severity between treated and untreated bites on a 10-point VAS score over 1 hour (AUC) Yellow fever mosquito (Aedes aegypti) and southern house mosquito (Culex quinquefasciatus) (10 patients)<br>- Difference in pruritus severity between treated and untreated bites on a 10-point VAS score at the time points 2, 7, 11, 15, 40, 60 minutes (AUC) for all mosquitoes and each individual mosquito<br>- Difference in swelling between treated and untreated bite on a 10-point VAS score over 1 hour (AUC)<br>- Difference in redness between treated and untreated bite on a 10 point VAS score over 1 hour (AUC)