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)

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.

Study Overview

• Status: Recruiting
• Conditions: Pediculosis Capitis; Head Lice Infestation; Lice
• Intervention / Treatment: Device: Dimet 5

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Beril Wachall; Email: studien@infectopharm.com

Study Locations

• Germany
  • Aalen, Germany
    • Active, not recruiting
    • Dr. med. Thilo Heising
  • Augsburg, Germany
    • Recruiting
    • Gemeinschaftspraxis Gilb/Bauer/von Bentzel
    • Contact: Thomas Gilb, DM
  • Balingen, Germany
    • Active, not recruiting
    • Dr. med. Omar Esteban Fernandez Salgueiro
  • Berlin, Germany
    • Withdrawn
    • Dr. med. Martin Wiesner
  • Blankenfelde, Germany
    • Recruiting
    • Praxis für Kinder- und Jugendheilkunde
    • Contact: Matthias Augustin da Glória Gonçalves, MD
  • Bremen, Germany
    • Recruiting
    • Gemeinschaftspraxis für Kinder- und Jugendmedizin
    • Contact: Britta Hartmann, MD
  • Chemnitz, Germany
    • Recruiting
    • Kinderarztpraxis Vaitl
    • Contact: Nadine Vaitl, MD
  • Düsseldorf, Germany
    • Recruiting
    • Praxis Dr. Glatzel
    • Contact: Thomas Glatzel, MD
  • Eschborn, Germany
    • Recruiting
    • Kinderarztpraxis Dr. Lichtenstein
    • Contact: Geri Lichtenstein, MD
  • Essen, Germany
    • Recruiting
    • Kinderarztpraxis Dr. Zumegen
    • Contact: Simone Zumegen, MD
  • Geldern, Germany
    • Recruiting
    • Gemeinschaftspraxis Dreher/Hübler
    • Contact: Tina Hübler, MD
  • Greifswald, Germany
    • Recruiting
    • Kinderärztliche Gemeinschaftspraxis Tost/Lange
    • Contact: Anja Lange, MD
  • Hamburg, Germany
    • Active, not recruiting
    • Dr. med. Friedrich Kaiser
  • Hürth, Germany
    • Recruiting
    • Dr. med. Ludwig Stapenhorst
    • Contact: Ludwig Stapenhorst, MD
  • Leipzig, Germany
    • Recruiting
    • Kinderarztpraxis Dr. Hable
    • Contact: Kersti Hable, MD
  • Leverkusen, Germany
    • Withdrawn
    • Kinderärzte im Karree
  • Lübeck, Germany
    • Withdrawn
    • Dr. med. Susanne Ludwig
  • Mainz, Germany
    • Recruiting
    • Kinderarztpraxis Dr. Bach
    • Contact: Joachim Bach, MD
  • München, Germany
    • Active, not recruiting
    • Dr. med. Katrin Biebach
  • Neuwied, Germany
    • Recruiting
    • Kinderarztpraxis am Ringmarkt
    • Contact: Bassem Irscheid, MD
  • Ratingen, Germany
    • Recruiting
    • Giraffenpraxis
    • Contact: Johanna Havran, MD
  • Saarbrücken, Germany
    • Recruiting
    • Kinderarztpraxis Dr. Steinmetz
    • Contact: Oliver Steinmetz, MD
  • Schwarzenberg, Germany
    • Recruiting
    • Kinderarztpraxis Dr. Klink
    • Contact: Stephanus Klink, MD
  • Schweigen-Rechtenbach, Germany
    • Active, not recruiting
    • Simon Traub
  • Weil Am Rhein, Germany
    • Recruiting
    • Kinder- und Jugendarztpraxis
    • Contact: Jürgen Müller, MD
  • Wolfsburg, Germany
    • Recruiting
    • PediaMed Wolfsburg
    • Contact: Maria Pniok, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Children ≥ 6 months with acute head lice infestation

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Dimet 5; The application is carried out according to the enclosed instructions for use.
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®).	Device: Dimet 5; The application is carried out according to the enclosed instructions for use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from infestation	Freedom from infestation of live head lice at the final examination (V2)	Day 17 to 21

Collaborators and Investigators

• Sponsor: Infectopharm Arzneimittel GmbH

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: May 4, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 7, 2021

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations; Parasitic Diseases
• Other Study ID Numbers: VEKODIH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No