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

March 5, 2024 updated by: Infectopharm Arzneimittel GmbH

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Freedom from infestation
Time Frame: Day 17 to 21
Freedom from infestation of live head lice at the final examination (V2)
Day 17 to 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Infectopharm Arzneimittel GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 4, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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