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)
Status: Recruiting
Location: See all (26) locations...
Intervention Type: Device
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 18
Healthy Volunteers: f
View:
• 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).
Locations
Other Locations
Germany
Dr. med. Thilo Heising
ACTIVE_NOT_RECRUITING
Aalen
Gemeinschaftspraxis Gilb/Bauer/von Bentzel
RECRUITING
Augsburg
Dr. med. Omar Esteban Fernandez Salgueiro
ACTIVE_NOT_RECRUITING
Balingen
Dr. med. Martin Wiesner
WITHDRAWN
Berlin
Praxis für Kinder- und Jugendheilkunde
RECRUITING
Blankenfelde
Gemeinschaftspraxis für Kinder- und Jugendmedizin
RECRUITING
Bremen
Kinderarztpraxis Vaitl
RECRUITING
Chemnitz
Praxis Dr. Glatzel
RECRUITING
Düsseldorf
Kinderarztpraxis Dr. Lichtenstein
RECRUITING
Eschborn
Kinderarztpraxis Dr. Zumegen
RECRUITING
Essen
Kinderärztliche Gemeinschaftspraxis Tost/Lange
RECRUITING
Greifswald
Gemeinschaftspraxis Dreher/Hübler
RECRUITING
Guelders
Dr. med. Friedrich Kaiser
ACTIVE_NOT_RECRUITING
Hamburg
Dr. med. Ludwig Stapenhorst
RECRUITING
Hürth
Kinderarztpraxis Dr. Hable
RECRUITING
Leipzig
Kinderärzte im Karree
WITHDRAWN
Leverkusen
Dr. med. Susanne Ludwig
WITHDRAWN
Lübeck
Kinderarztpraxis Dr. Bach
RECRUITING
Mainz
Dr. med. Katrin Biebach
ACTIVE_NOT_RECRUITING
München
Kinderarztpraxis am Ringmarkt
RECRUITING
Neuwied
Giraffenpraxis
RECRUITING
Ratingen
Kinderarztpraxis Dr. Steinmetz
RECRUITING
Saarbrücken
Kinderarztpraxis Dr. Klink
RECRUITING
Schwarzenberg
Simon Traub
ACTIVE_NOT_RECRUITING
Schweigen-rechtenbach
Kinder- und Jugendarztpraxis
RECRUITING
Weil Am Rhein
PediaMed Wolfsburg
RECRUITING
Wolfsburg
Contact Information
Primary
Beril Wachall
studien@infectopharm.com
Time Frame
Start Date: 2021-05-17
Estimated Completion Date: 2026-03
Participants
Target number of participants: 240
Treatments
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®).
Related Therapeutic Areas
Sponsors
Leads: Infectopharm Arzneimittel GmbH