Comparative Head Lice Therapy With Dimet 5® vs. Hedrin® Once (NCT04878276) | Clinical Trial Compass
UnknownNot Applicable
Comparative Head Lice Therapy With Dimet 5® vs. Hedrin® Once
Germany240 participantsStarted 2021-05-17
Plain-language 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.
Who can participate
Age range6 Months – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 gu…