Comparing two treatments for head lice in children
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)
This study is testing which of two treatments for head lice works better in children aged 6 months and older.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 6 Months to 18 Years |
| Sex | All |
| Sponsor | Infectopharm Arzneimittel GmbH Industry-sponsored |
| Locations | 26 sites (Aalen and 25 other locations) |
| Trial ID | NCT04878276 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of two dimeticone-based treatments for acute head lice infestation in children: Dimet 5® and Hedrin® Once. It is a randomized, investigator-blinded, controlled, multicenter study that assesses treatment success by evaluating the absence of live head lice 19 days after the initial treatment. The study aims to determine which treatment is more effective in eliminating head lice. Participants will be children aged 6 months and older who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 months and older with an acute head lice infestation.
Not a fit: Patients who are adults or have had scalp lice therapy in the previous 2 weeks will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for children suffering from head lice infestations.
How similar studies have performed: Other studies have shown success with similar dimeticone-based treatments for head lice, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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) * 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.
Where this trial is running
Aalen and 25 other locations
- Dr. med. Thilo Heising — Aalen, Germany (Active_not_recruiting)
- Gemeinschaftspraxis Gilb/Bauer/von Bentzel — Augsburg, Germany (Recruiting)
- Dr. med. Omar Esteban Fernandez Salgueiro — Balingen, Germany (Active_not_recruiting)
- Dr. med. Martin Wiesner — Berlin, Germany (Withdrawn)
- Praxis für Kinder- und Jugendheilkunde — Blankenfelde, Germany (Recruiting)
- Gemeinschaftspraxis für Kinder- und Jugendmedizin — Bremen, Germany (Recruiting)
- Kinderarztpraxis Vaitl — Chemnitz, Germany (Recruiting)
- Praxis Dr. Glatzel — Düsseldorf, Germany (Recruiting)
- Kinderarztpraxis Dr. Lichtenstein — Eschborn, Germany (Recruiting)
- Kinderarztpraxis Dr. Zumegen — Essen, Germany (Recruiting)
- Gemeinschaftspraxis Dreher/Hübler — Geldern, Germany (Recruiting)
- Kinderärztliche Gemeinschaftspraxis Tost/Lange — Greifswald, Germany (Recruiting)
- Dr. med. Friedrich Kaiser — Hamburg, Germany (Active_not_recruiting)
- Dr. med. Ludwig Stapenhorst — Hürth, Germany (Recruiting)
- Kinderarztpraxis Dr. Hable — Leipzig, Germany (Recruiting)
- Kinderärzte im Karree — Leverkusen, Germany (Withdrawn)
- Dr. med. Susanne Ludwig — Lübeck, Germany (Withdrawn)
- Kinderarztpraxis Dr. Bach — Mainz, Germany (Recruiting)
- Dr. med. Katrin Biebach — München, Germany (Active_not_recruiting)
- Kinderarztpraxis am Ringmarkt — Neuwied, Germany (Recruiting)
- Giraffenpraxis — Ratingen, Germany (Recruiting)
- Kinderarztpraxis Dr. Steinmetz — Saarbrücken, Germany (Recruiting)
- Kinderarztpraxis Dr. Klink — Schwarzenberg, Germany (Recruiting)
- Simon Traub — Schweigen-Rechtenbach, Germany (Active_not_recruiting)
- Kinder- und Jugendarztpraxis — Weil Am Rhein, Germany (Recruiting)
- PediaMed Wolfsburg — Wolfsburg, Germany (Recruiting)
Study contacts
- Study coordinator: Beril Wachall
- Email: studien@infectopharm.com
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.