Clinical trial NCT04878276: Comparative Head Lice Therapy With Dimet 5® vs. Hedrin® Once
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head Lice Infestation
Pediculosis Capitis
Lice
Lead sponsor: Infectopharm Arzneimittel GmbH
Sponsor class: INDUSTRY
First posted: 2021-05-07
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children ≥ 6 months with acute head lice infestation

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.


Eligibility 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.

Primary outcomes:
measure: Freedom from infestation
timeFrame: Day 17 to 21
Secondary outcomes:
Other outcomes:
Locations:
city: Aalen
country: Germany
facility: Dr. med. Thilo Heising
city: Augsburg
country: Germany
facility: Gemeinschaftspraxis Gilb/Bauer/von Bentzel
city: Balingen
country: Germany
facility: Dr. med. Omar Esteban Fernandez Salgueiro
city: Berlin
country: Germany
facility: Dr. med. Martin Wiesner
city: Blankenfelde
country: Germany
facility: Praxis für Kinder- und Jugendheilkunde
city: Bremen
country: Germany
facility: Gemeinschaftspraxis für Kinder- und Jugendmedizin
city: Chemnitz
country: Germany
facility: Kinderarztpraxis Vaitl
city: Düsseldorf
country: Germany
facility: Praxis Dr. Glatzel
city: Eschborn
country: Germany
facility: Kinderarztpraxis Dr. Lichtenstein
city: Essen
country: Germany
facility: Kinderarztpraxis Dr. Zumegen
city: Geldern
country: Germany
facility: Gemeinschaftspraxis Dreher/Hübler
city: Greifswald
country: Germany
facility: Kinderärztliche Gemeinschaftspraxis Tost/Lange
city: Hamburg
country: Germany
facility: Dr. med. Friedrich Kaiser
city: Hürth
country: Germany
facility: Dr. med. Ludwig Stapenhorst
city: Leipzig
country: Germany
facility: Kinderarztpraxis Dr. Hable
city: Leverkusen
country: Germany
facility: Kinderärzte im Karree
city: Lübeck
country: Germany
facility: Dr. med. Susanne Ludwig
city: Mainz
country: Germany
facility: Kinderarztpraxis Dr. Bach
city: München
country: Germany
facility: Dr. med. Katrin Biebach
city: Neuwied
country: Germany
facility: Kinderarztpraxis am Ringmarkt
city: Ratingen
country: Germany
facility: Giraffenpraxis
city: Saarbrücken
country: Germany
facility: Kinderarztpraxis Dr. Steinmetz
city: Schwarzenberg
country: Germany
facility: Kinderarztpraxis Dr. Klink
city: Schweigen-Rechtenbach
country: Germany
facility: Simon Traub
city: Weil Am Rhein
country: Germany
facility: Kinder- und Jugendarztpraxis
city: Wolfsburg
country: Germany
facility: PediaMed Wolfsburg
Study officials:
References: