Comparative Head Lice Therapy With Dimet 5® vs. Hedrin® Once
VEKODIH
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)
1 other identifier
observational
240
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2021
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2021
CompletedFirst Posted
Study publicly available on registry
May 7, 2021
CompletedStudy Start
First participant enrolled
May 17, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2026
CompletedMarch 6, 2024
March 1, 2024
4.8 years
May 4, 2021
March 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Freedom from infestation
Freedom from infestation of live head lice at the final examination (V2)
Day 17 to 21
Study Arms (2)
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
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®).
Interventions
The application is carried out according to the enclosed instructions for use.
Eligibility Criteria
Children ≥ 6 months with acute head lice infestation
You may qualify if:
- 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).
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
Dr. med. Thilo Heising
Aalen, Germany
Gemeinschaftspraxis Gilb/Bauer/von Bentzel
Augsburg, Germany
Dr. med. Omar Esteban Fernandez Salgueiro
Balingen, Germany
Dr. med. Martin Wiesner
Berlin, Germany
Praxis für Kinder- und Jugendheilkunde
Blankenfelde, Germany
Gemeinschaftspraxis für Kinder- und Jugendmedizin
Bremen, Germany
Kinderarztpraxis Vaitl
Chemnitz, Germany
Praxis Dr. Glatzel
Düsseldorf, Germany
Kinderarztpraxis Dr. Lichtenstein
Eschborn, Germany
Kinderarztpraxis Dr. Zumegen
Essen, Germany
Kinderärztliche Gemeinschaftspraxis Tost/Lange
Greifswald, Germany
Gemeinschaftspraxis Dreher/Hübler
Guelders, 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
Kinderarztpraxis Dr. Bach
Mainz, Germany
Dr. med. Katrin Biebach
München, Germany
Kinderarztpraxis am Ringmarkt
Neuwied, Germany
Giraffenpraxis
Ratingen, Germany
Kinderarztpraxis Dr. Steinmetz
Saarbrücken, Germany
Kinderarztpraxis Dr. Klink
Schwarzenberg, Germany
Simon Traub
Schweigen-Rechtenbach, Germany
Kinder- und Jugendarztpraxis
Weil am Rhein, Germany
PediaMed Wolfsburg
Wolfsburg, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2021
First Posted
May 7, 2021
Study Start
May 17, 2021
Primary Completion
March 1, 2026
Study Completion
March 1, 2026
Last Updated
March 6, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share