AzTrials
AzTrials

Head Lice InfestationVEKODIHNCT04878276

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

An observational study of Head Lice Infestation and Pediculosis Capitis, run by Infectopharm Arzneimittel GmbH at 26 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 6 months to 18 years
Conditions the study is for
Head Lice Infestation, Pediculosis Capitis, Lice
What is being tested?
Dimet 5
Type of treatment
Medical device
How many people
240 participants
Where
26 sitesGermany
Study dates
17 May 2021to Mar 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Children ≥ 6 months with acute head lice infestation

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

26 sites in 1 country.

Beril Wachall contact

studien@infectopharm.com

26 sites in 1 country

Germany26 sites, 18 recruiting

  • Dr. med. Thilo Heising

    Aalen

    Active, not recruiting

  • Gemeinschaftspraxis Gilb/Bauer/von Bentzel

    Augsburg

    Thomas Gilb, DM

    Recruiting

  • Dr. med. Omar Esteban Fernandez Salgueiro

    Balingen

    Active, not recruiting

  • Dr. med. Martin Wiesner

    Berlin

    Withdrawn

  • Praxis für Kinder- und Jugendheilkunde

    Blankenfelde

    Matthias Augustin da Glória Gonçalves, MD

    Recruiting

  • Gemeinschaftspraxis für Kinder- und Jugendmedizin

    Bremen

    Britta Hartmann, MD

    Recruiting

  • Kinderarztpraxis Vaitl

    Chemnitz

    Nadine Vaitl, MD

    Recruiting

  • Praxis Dr. Glatzel

    Düsseldorf

    Thomas Glatzel, MD

    Recruiting

  • Kinderarztpraxis Dr. Lichtenstein

    Eschborn

    Geri Lichtenstein, MD

    Recruiting

  • Kinderarztpraxis Dr. Zumegen

    Essen

    Simone Zumegen, MD

    Recruiting

  • Kinderärztliche Gemeinschaftspraxis Tost/Lange

    Greifswald

    Anja Lange, MD

    Recruiting

  • Gemeinschaftspraxis Dreher/Hübler

    Guelders

    Tina Hübler, MD

    Recruiting

  • Dr. med. Friedrich Kaiser

    Hamburg

    Active, not recruiting

  • Dr. med. Ludwig Stapenhorst

    Hürth

    Ludwig Stapenhorst, MD

    Recruiting

  • Kinderarztpraxis Dr. Hable

    Leipzig

    Kersti Hable, MD

    Recruiting

  • Kinderärzte im Karree

    Leverkusen

    Withdrawn

  • Dr. med. Susanne Ludwig

    Lübeck

    Withdrawn

  • Kinderarztpraxis Dr. Bach

    Mainz

    Joachim Bach, MD

    Recruiting

  • Dr. med. Katrin Biebach

    München

    Active, not recruiting

  • Kinderarztpraxis am Ringmarkt

    Neuwied

    Bassem Irscheid, MD

    Recruiting

  • Giraffenpraxis

    Ratingen

    Johanna Havran, MD

    Recruiting

  • Kinderarztpraxis Dr. Steinmetz

    Saarbrücken

    Oliver Steinmetz, MD

    Recruiting

  • Kinderarztpraxis Dr. Klink

    Schwarzenberg

    Stephanus Klink, MD

    Recruiting

  • Simon Traub

    Schweigen-Rechtenbach

    Active, not recruiting

  • Kinder- und Jugendarztpraxis

    Weil am Rhein

    Jürgen Müller, MD

    Recruiting

  • PediaMed Wolfsburg

    Wolfsburg

    Maria Pniok, MD

    Recruiting

Other trials in Germany

About this study

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)

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.

Being tested
Dimet 5
Medical subject headings
Lice Infestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dimet 5Device

    The application is carried out according to the enclosed instructions for use.

Study groups in NCT04878276
Study groupRoleWhat they receive
Dimet 5Dimet 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.
Receives: Device: Dimet 5
Hedrin Once Liquid GelHedrin 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®).
Receives: Device: Dimet 5

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom from infestation

    Freedom from infestation of live head lice at the final examination (V2)

    Measured: Day 17 to 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2021
  2. Study start17 May 2021
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04878276
Sponsor's protocol ID
VEKODIH
Acronym
VEKODIH
Status last verified
Mar 2024
First submitted
4 May 2021
Last updated
6 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Head Lice Infestation and Pediculosis Capitis, run by Infectopharm Arzneimittel GmbH at 26 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Beril Wachall (studien@infectopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from infestation (time frame: Day 17 to 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04878276.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in