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

Pediculosis Capitis Clinical Trial

— VEKODIH  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04878276
• Other study ID #: VEKODIH
• Status: Recruiting
• Start date: May 17, 2021
• Est. completion date: March 2026

Study information

• Verified date: March 2024
• Source: Infectopharm Arzneimittel GmbH
• Contact: Beril Wachall
• Email: studien[@]infectopharm.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 success assessment via freedom from infestation of live head lice at final examination at V2, i.e. day 19 after first treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head Lice Infestation
• Lice
• Lice Infestations
• Parasitic Diseases
• Pediculosis Capitis

Intervention

Device:
• Dimet 5
The application is carried out according to the enclosed instructions for use.

Locations

Country	Name	City	State
Germany	Dr. med. Thilo Heising	Aalen
Germany	Gemeinschaftspraxis Gilb/Bauer/von Bentzel	Augsburg
Germany	Dr. med. Omar Esteban Fernandez Salgueiro	Balingen
Germany	Dr. med. Martin Wiesner	Berlin
Germany	Praxis für Kinder- und Jugendheilkunde	Blankenfelde
Germany	Gemeinschaftspraxis für Kinder- und Jugendmedizin	Bremen
Germany	Kinderarztpraxis Vaitl	Chemnitz
Germany	Praxis Dr. Glatzel	Düsseldorf
Germany	Kinderarztpraxis Dr. Lichtenstein	Eschborn
Germany	Kinderarztpraxis Dr. Zumegen	Essen
Germany	Gemeinschaftspraxis Dreher/Hübler	Geldern
Germany	Kinderärztliche Gemeinschaftspraxis Tost/Lange	Greifswald
Germany	Dr. med. Friedrich Kaiser	Hamburg
Germany	Dr. med. Ludwig Stapenhorst	Hürth
Germany	Kinderarztpraxis Dr. Hable	Leipzig
Germany	Kinderärzte im Karree	Leverkusen
Germany	Dr. med. Susanne Ludwig	Lübeck
Germany	Kinderarztpraxis Dr. Bach	Mainz
Germany	Dr. med. Katrin Biebach	München
Germany	Kinderarztpraxis am Ringmarkt	Neuwied
Germany	Giraffenpraxis	Ratingen
Germany	Kinderarztpraxis Dr. Steinmetz	Saarbrücken
Germany	Kinderarztpraxis Dr. Klink	Schwarzenberg
Germany	Simon Traub	Schweigen-Rechtenbach
Germany	Kinder- und Jugendarztpraxis	Weil Am Rhein
Germany	PediaMed Wolfsburg	Wolfsburg

Sponsors (1)

Lead Sponsor	Collaborator
Infectopharm Arzneimittel GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from infestation	Freedom from infestation of live head lice at the final examination (V2)	Day 17 to 21