An observational study in Head Lice Infestation, Pediculosis Capitis and Lice, sponsored by Infectopharm Arzneimittel GmbH. Recruiting at 26 sites in Germany. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Infectopharm Arzneimittel GmbH · Observational
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.
43 studies on the registry are indexed under Lice Infestations; 4 are open to participants now.
Browse Lice Infestations studies →Infectopharm Arzneimittel GmbH is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
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Children ≥ 6 months with acute head lice infestation
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Adequate for study participation:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
The application is carried out according to the enclosed instructions for use.
Freedom from infestation
Freedom from infestation of live head lice at the final examination (V2)
Time frame: Day 17 to 21
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Plan to share: No
No publications or documents are linked to this record.
Started May 2021 (actual). Primary completion is estimated for Mar 2026, 58 months after the start.
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Infectopharm Arzneimittel GmbH