Comparative Head Lice Therapy With Dimet 5® vs. Hedrin® Once

Study Overview
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Brief Summary
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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.

Official Title
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Randomised, Investigator-blinded, Controlled, Multicentre Comparative Study on the Treatment of Head Lice Infestation With 2 Dimeticone Preparations With Different Application Times and Compositions: Dimet 5® (100% Dimeticon) Versus Hedrin® Once Liquid Gel (4% Dimeticon + Nerolidol)

Conditions
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Head Lice Infestation, Pediculosis Capitis, Lice

Intervention / Treatment
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* Device: Dimet 5


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dimet 5<br>Dimet 5 is a certified medical device for the treatment of head lice infestation. It contains only (liquid) dimeticone oil and, when used correctly, enables physical killing of head lice and their eggs. | Device: Dimet 5<br>* The application is carried out according to the enclosed instructions for use.<br>|
| Hedrin Once Liquid Gel<br>Hedrin Once Liquid Gel is a certified medical product for the removal of head lice and nits. The liquid gel contains 4% dimethicone and nerolidol (Penetrol®). | Device: Dimet 5<br>* The application is carried out according to the enclosed instructions for use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from infestation | Freedom from infestation of live head lice at the final examination (V2) | Day 17 to 21 |