Comparative Head Lice Therapy With Dimet 5® vs. Hedrin® Once
Trial Parameters
Brief Summary
Randomized, investigator-blinded, controlled, multicenter comparative study on the treatment of acute head lice infestation in children with 2 dimeticone preparations with different application times and compositions: Dimet 5® (100% dimeticone) versus Hedrin® Once Liquid Gel (4% dimeticone + nerolidol) with treatment success assessment via freedom from infestation of live head lice at final examination at V2, i.e. day 19 after first treatment.
Eligibility Criteria
Inclusion Criteria: * Acute head lice infestation * Age ≥ 6 months * Adequate informed consent for study participation: * Age-appropriate informed consent and verbal informed consent from the patient (if capable of both). * Written informed consent from the legal guardian(s) (written and verbal). Exclusion Criteria: * Adults (≥ 18 years of age) * Known hypersensitivity to any component of the test or comparator product. * Scalp lice therapy in the previous 2 weeks (with an appropriate drug or medical device). * Severe disease of the scalp or injuries/open wounds on the hairy head * Secondary infection in the area of the hairy head * Treatment with cotrimoxazole or trimethoprim in the last 4 weeks or new treatment to be initiated now * Other relevant reasons, e.g. diseases or dysfunctions, which, in the opinion of the investigator, militate against the inclusion of the patient in the study (including risk factors for severe COVID-19 disease in the case of SARS-CoV-2 infection) * Simulta