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

InfectoPharm

Status: Enrolling

Conditions: Pediculosis Capitis; Lice; Head Lice Infestation

Treatments: Device: Dimet 5

Study type: Observational

Funder types: Industry

Identifiers

NCT04878276

VEKODIH

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 6 months to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

240 participants in 2 patient groups

Dimet 5

Description:

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.

Treatment:

Device: Dimet 5

Hedrin Once Liquid Gel

Description:

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®).

Treatment:

Device: Dimet 5