Itching and swelling after mosquiot bites
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 2. Written consent for the study 3. Voluntary mosquito bites on the right and left forearm (4-6 bites per subject and per forearm) 4. Consent to randomization (determining which forearm will be treated with MOSKINTO) 5. Consent to non-treatment of the non-MOSKINTO forearm while participating in the study
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, trying to become pregnant or breastfeeding. 2. Wounds in the arm area 3. Amputations in the area of both arms 4. Known allergies to patches 5. Known allergies to mosquito bites
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the change in itching after mosquito bites from baseline (15 minutes after mosquito bites before administration of the mosquito patches) to 1 hour. Survey of the subjects | — |
Secondary
| Measure | Time frame |
|---|---|
| • Change in itching after mosquito bites from baseline (15 minutes after mosquito bites) to 30 minutes, 3 hours, 6 hours and 24 hours • Change in swelling after mosquito bites from baseline (15 minutes after mosquito bites) to 30 minutes, 1 hour, 3 hours, 6 hours and 24 hours • Assessment of wearing comfort after 24 hours (school grades from 1=very good to 6=unsatisfactory) • Assessment of satisfaction with the MOSKINTO therapy (school grades from 1=very good to 6=unsatisfactory) • Proportion of patients with adverse events, serious adverse events, incident events, serious incidents, and device deficencies | — |
Countries
Germany
Contacts
Bernhard Nocht Institute for Tropical Medicine & I Dept. of Medicine University Medical Center Hamburg-Eppendorf