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

Last updated: March 5, 2024
Sponsor: Infectopharm Arzneimittel GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

Head Lice

Treatment

Dimet 5

Clinical Study ID

NCT04878276
VEKODIH
  • Ages 6-18
  • All Genders

Study 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

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 (ifcapable of both).
  • Written informed consent from the legal guardian(s) (written and verbal).

Exclusion

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 medicaldevice).
  • 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 tobe initiated now
  • Other relevant reasons, e.g. diseases or dysfunctions, which, in the opinion of theinvestigator, militate against the inclusion of the patient in the study (includingrisk 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 legalguardian(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

Total Participants: 240
Treatment Group(s): 1
Primary Treatment: Dimet 5
Phase:
Study Start date:
May 17, 2021
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Dr. med. Thilo Heising

    Aalen,
    Germany

    Site Not Available

  • Gemeinschaftspraxis Gilb/Bauer/von Bentzel

    Augsburg,
    Germany

    Active - Recruiting

  • Dr. med. Omar Esteban Fernandez Salgueiro

    Balingen,
    Germany

    Site Not Available

  • Dr. med. Martin Wiesner

    Berlin,
    Germany

    Site Not Available

  • Praxis für Kinder- und Jugendheilkunde

    Blankenfelde,
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis für Kinder- und Jugendmedizin

    Bremen,
    Germany

    Active - Recruiting

  • Kinderarztpraxis Vaitl

    Chemnitz,
    Germany

    Active - Recruiting

  • Praxis Dr. Glatzel

    Düsseldorf,
    Germany

    Active - Recruiting

  • Kinderarztpraxis Dr. Lichtenstein

    Eschborn,
    Germany

    Active - Recruiting

  • Kinderarztpraxis Dr. Zumegen

    Essen,
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis Dreher/Hübler

    Geldern,
    Germany

    Active - Recruiting

  • Kinderärztliche Gemeinschaftspraxis Tost/Lange

    Greifswald,
    Germany

    Active - Recruiting

  • Dr. med. Friedrich Kaiser

    Hamburg,
    Germany

    Site Not Available

  • Dr. med. Ludwig Stapenhorst

    Hürth,
    Germany

    Active - Recruiting

  • Kinderarztpraxis Dr. Hable

    Leipzig,
    Germany

    Active - Recruiting

  • Kinderärzte im Karree

    Leverkusen,
    Germany

    Site Not Available

  • Dr. med. Susanne Ludwig

    Lübeck,
    Germany

    Site Not Available

  • Kinderarztpraxis Dr. Bach

    Mainz,
    Germany

    Active - Recruiting

  • Dr. med. Katrin Biebach

    München,
    Germany

    Site Not Available

  • Kinderarztpraxis am Ringmarkt

    Neuwied,
    Germany

    Active - Recruiting

  • Giraffenpraxis

    Ratingen,
    Germany

    Active - Recruiting

  • Kinderarztpraxis Dr. Steinmetz

    Saarbrücken,
    Germany

    Active - Recruiting

  • Kinderarztpraxis Dr. Klink

    Schwarzenberg,
    Germany

    Active - Recruiting

  • Simon Traub

    Schweigen-Rechtenbach,
    Germany

    Site Not Available

  • Kinder- und Jugendarztpraxis

    Weil Am Rhein,
    Germany

    Active - Recruiting

  • PediaMed Wolfsburg

    Wolfsburg,
    Germany

    Active - Recruiting

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