ClinicalTrials.gg
RecruitingNCT04878276VEKODIHUpdated Mar 6, 2024

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

An observational study in Head Lice Infestation, Pediculosis Capitis and Lice, sponsored by Infectopharm Arzneimittel GmbH. Recruiting at 26 sites in Germany. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2024-03-06.

Sponsored by Infectopharm Arzneimittel GmbH · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started May 2021; still recruiting 5 years 5 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
240
Ages
6 Months to 18 Years
Sex
All
01

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.

02

Conditions studied

  • Head Lice Infestation
  • Pediculosis Capitis
  • Lice

Browse trials for

03

In context

Lice Infestations

43 studies on the registry are indexed under Lice Infestations; 4 are open to participants now.

Browse Lice Infestations studies →

Lead sponsor

Infectopharm Arzneimittel GmbH is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children ≥ 6 months with acute head lice infestation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Acute head lice infestation
  • Age ≥ 6 months
  • Adequate 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

Exclusion Criteria:

  • Adults (≥ 18 years of age)
  • Known 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
240 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • DeviceDimet 5

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

06

What researchers measure

Primary outcomes

  1. Freedom from infestation

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

    Time frame: Day 17 to 21

07

Study locations

18 of 26 sites recruiting
  • Dr. med. Thilo Heising
    Aalen, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Gemeinschaftspraxis Gilb/Bauer/von Bentzel
    Augsburg, Germany
    Recruiting
    • Thomas Gilb, DM · Contact
  • Dr. med. Omar Esteban Fernandez Salgueiro
    Balingen, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Dr. med. Martin Wiesner
    Berlin, Germany
    Withdrawn

    Not enrolling at this site — choose another above.

  • Praxis für Kinder- und Jugendheilkunde
    Blankenfelde, Germany
    Recruiting
    • Matthias Augustin da Glória Gonçalves, MD · Contact
  • Gemeinschaftspraxis für Kinder- und Jugendmedizin
    Bremen, Germany
    Recruiting
    • Britta Hartmann, MD · Contact
  • Kinderarztpraxis Vaitl
    Chemnitz, Germany
    Recruiting
    • Nadine Vaitl, MD · Contact
  • Praxis Dr. Glatzel
    Düsseldorf, Germany
    Recruiting
    • Thomas Glatzel, MD · Contact
  • Kinderarztpraxis Dr. Lichtenstein
    Eschborn, Germany
    Recruiting
    • Geri Lichtenstein, MD · Contact
  • Kinderarztpraxis Dr. Zumegen
    Essen, Germany
    Recruiting
    • Simone Zumegen, MD · Contact
  • Gemeinschaftspraxis Dreher/Hübler
    Geldern, Germany
    Recruiting
    • Tina Hübler, MD · Contact
  • Kinderärztliche Gemeinschaftspraxis Tost/Lange
    Greifswald, Germany
    Recruiting
    • Anja Lange, MD · Contact
  • Dr. med. Friedrich Kaiser
    Hamburg, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Dr. med. Ludwig Stapenhorst
    Hürth, Germany
    Recruiting
    • Ludwig Stapenhorst, MD · Contact
  • Kinderarztpraxis Dr. Hable
    Leipzig, Germany
    Recruiting
    • Kersti Hable, MD · Contact
  • Kinderärzte im Karree
    Leverkusen, Germany
    Withdrawn

    Not enrolling at this site — choose another above.

  • Dr. med. Susanne Ludwig
    Lübeck, Germany
    Withdrawn

    Not enrolling at this site — choose another above.

  • Kinderarztpraxis Dr. Bach
    Mainz, Germany
    Recruiting
    • Joachim Bach, MD · Contact
  • Dr. med. Katrin Biebach
    München, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Kinderarztpraxis am Ringmarkt
    Neuwied, Germany
    Recruiting
    • Bassem Irscheid, MD · Contact
  • Giraffenpraxis
    Ratingen, Germany
    Recruiting
    • Johanna Havran, MD · Contact
  • Kinderarztpraxis Dr. Steinmetz
    Saarbrücken, Germany
    Recruiting
    • Oliver Steinmetz, MD · Contact
  • Kinderarztpraxis Dr. Klink
    Schwarzenberg, Germany
    Recruiting
    • Stephanus Klink, MD · Contact
  • Simon Traub
    Schweigen-Rechtenbach, Germany
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Kinder- und Jugendarztpraxis
    Weil Am Rhein, Germany
    Recruiting
    • Jürgen Müller, MD · Contact
  • PediaMed Wolfsburg
    Wolfsburg, Germany
    Recruiting
    • Maria Pniok, MD · Contact
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2021 (actual). Primary completion is estimated for Mar 2026, 58 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
May 4, 2021
First posted
May 7, 2021
StartActual
May 17, 2021
Primary completionEst.
Mar 2026
CompletionEst.
Mar 2026
Last update
Mar 6, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04878276
Lead sponsor
Infectopharm Arzneimittel GmbH
Responsible party
Sponsor
First posted
May 7, 2021
Start date
May 17, 2021
Primary completion
Mar 2026 (estimated)
Completion
Mar 2026 (estimated)
Last update
Mar 6, 2024

Study contacts

Beril Wachall
Contact
studien@infectopharm.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion