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

Recruiting

• Conditions: Head Lice Infestation; Lice; Pediculosis Capitis
• Interventions: Device: Dimet 5

• Registration Number: NCT04878276
• Lead Sponsor: Infectopharm Arzneimittel GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-04
• Study First Posted: 2021-05-07
• Study Start: 2021-05-17
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dimet 5	Dimet 5	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.
Hedrin Once Liquid Gel	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®).

Primary Outcome Measures

Name	Time	Method
Freedom from infestation	Day 17 to 21	Freedom from infestation of live head lice at the final examination (V2)

Trial Locations

Locations (26)

Dr. med. Omar Esteban Fernandez Salgueiro; 🇩🇪 Balingen, Germany

Dr. med. Thilo Heising; 🇩🇪 Aalen, Germany

Gemeinschaftspraxis Gilb/Bauer/von Bentzel; 🇩🇪 Augsburg, Germany

Dr. med. Martin Wiesner; 🇩🇪 Berlin, Germany

Gemeinschaftspraxis für Kinder- und Jugendmedizin; 🇩🇪 Bremen, Germany

Praxis für Kinder- und Jugendheilkunde; 🇩🇪 Blankenfelde, Germany

Kinderarztpraxis Dr. Lichtenstein; 🇩🇪 Eschborn, Germany

Kinderarztpraxis Vaitl; 🇩🇪 Chemnitz, Germany

Praxis Dr. Glatzel; 🇩🇪 Düsseldorf, Germany

Gemeinschaftspraxis Dreher/Hübler; 🇩🇪 Geldern, Germany

Kinderarztpraxis Dr. Zumegen; 🇩🇪 Essen, Germany

Kinderärztliche Gemeinschaftspraxis Tost/Lange; 🇩🇪 Greifswald, Germany

Dr. med. Friedrich Kaiser; 🇩🇪 Hamburg, Germany

Dr. med. Ludwig Stapenhorst; 🇩🇪 Hürth, Germany

Kinderarztpraxis Dr. Hable; 🇩🇪 Leipzig, Germany

Kinderärzte im Karree; 🇩🇪 Leverkusen, Germany

Dr. med. Susanne Ludwig; 🇩🇪 Lübeck, Germany

Dr. med. Katrin Biebach; 🇩🇪 München, Germany

Kinderarztpraxis Dr. Bach; 🇩🇪 Mainz, Germany

Kinderarztpraxis Dr. Steinmetz; 🇩🇪 Saarbrücken, Germany

Kinderarztpraxis am Ringmarkt; 🇩🇪 Neuwied, Germany

Giraffenpraxis; 🇩🇪 Ratingen, Germany

Kinderarztpraxis Dr. Klink; 🇩🇪 Schwarzenberg, Germany

Simon Traub; 🇩🇪 Schweigen-Rechtenbach, Germany

Kinder- und Jugendarztpraxis; 🇩🇪 Weil Am Rhein, Germany

PediaMed Wolfsburg; 🇩🇪 Wolfsburg, Germany