drugset / Trial / NCT03578679

Treatment of Pediculosis (Head Lice) in Senegal

NCT03578679

Completed 450 enrolled Research Institute for Development
NaSingle-groupOpen-labelTreatment

Summary

This is a prospective single-arm interventional study evaluating Therapeutic efficacy of a combination of two pharmaceutical drugs, Azithromycin (AZIT) and Ivermectin (IVER) administered orally in the treatment of head lice infestations. In case of persistence of lice and / or nits on day 7, a second oral administration of combination Azithromycin + Ivermectin will be considered. The duration of the study period is 4 months, ie 1 month and ½ of inclusion and 2 months and ½ feedback. There will be a site initiation visit "site initiation visit" before inclusions at D-7, two monitoring visits and a closing visit "close out visit" at the end of the follow-up at 4 months.

Timeline

Start
2018-07-11
Primary completion
2019-01-31
Completion
2019-02-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Azithromycin Small molecule Oral
Subject Ivermectin Small molecule Oral