Head Lice Infestation, Lice, Pediculosis Capitis
Conditions
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.
Interventions
DEVICEDimet 5
The application is carried out according to the enclosed instructions for use.
Sponsors
Infectopharm Arzneimittel GmbH
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
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) * Simultaneous participation of another household member in the trial. * Previous participation in this trial * Participation in another trial within the last 30 days * Inability of the legal guardian(s) to understand the study content and instructions. * Limited legal capacity of the legal guardian(s) * Apparent unreliability or unwillingness to cooperate on the part of the legal guardian(s) * Known alcohol, medication or drug dependency of the legal guardian(s) * Dependence of the patient or guardian on the sponsor or investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from infestation | Day 17 to 21 | Freedom from infestation of live head lice at the final examination (V2) |
Countries
Germany
Contacts
Primary ContactBeril Wachall
Outcome results
None listed