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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04878276
Recruitment Status : Recruiting
First Posted : May 7, 2021
Last Update Posted : March 1, 2023
Sponsor:
Information provided by (Responsible Party):
Infectopharm Arzneimittel GmbH

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Head Lice Infestation Pediculosis Capitis Lice Device: Dimet 5

Study Design
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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Other
Time Perspective: Prospective
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)
Actual Study Start Date : May 17, 2021
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from infestation [ Time Frame: Day 17 to 21 ]
    Freedom from infestation of live head lice at the final examination (V2)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children ≥ 6 months with acute head lice infestation
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04878276


Contacts
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Contact: Beril Wachall studien@infectopharm.com

Locations
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Germany
Dr. med. Thilo Heising Active, not recruiting
Aalen, Germany
Gemeinschaftspraxis Gilb/Bauer/von Bentzel Recruiting
Augsburg, Germany
Contact: Thomas Gilb, DM         
Dr. med. Omar Esteban Fernandez Salgueiro Active, not recruiting
Balingen, Germany
Dr. med. Martin Wiesner Active, not recruiting
Berlin, Germany
Dr. med. Friedrich Kaiser Active, not recruiting
Hamburg, Germany
Dr. med. Ludwig Stapenhorst Recruiting
Hürth, Germany
Contact: Ludwig Stapenhorst, MD         
Dr. med. Susanne Ludwig Active, not recruiting
Lübeck, Germany
Dr. med. Katrin Biebach Active, not recruiting
München, Germany
Simon Traub Active, not recruiting
Schweigen-Rechtenbach, Germany
Sponsors and Collaborators
Infectopharm Arzneimittel GmbH
More Information
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Responsible Party: Infectopharm Arzneimittel GmbH
ClinicalTrials.gov Identifier: NCT04878276    
Other Study ID Numbers: VEKODIH
First Posted: May 7, 2021    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lice Infestations
Parasitic Diseases
Ectoparasitic Infestations
Skin Diseases, Parasitic
 Infections
Skin Diseases, Infectious
Skin Diseases