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 range
6 Months – 18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.