Status:
RECRUITING
Comparative Head Lice Therapy With Dimet 5® vs. Hedrin® Once
Lead Sponsor:
Infectopharm Arzneimittel GmbH
Conditions:
Head Lice Infestation
Pediculosis Capitis
Eligibility:
All Genders
6-18 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04878276
Start Date
May 17 2021
End Date
March 1 2026
Last Update
March 6 2024
Active Locations (26)
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1
Dr. med. Thilo Heising
Aalen, Germany
2
Gemeinschaftspraxis Gilb/Bauer/von Bentzel
Augsburg, Germany
3
Dr. med. Omar Esteban Fernandez Salgueiro
Balingen, Germany
4
Dr. med. Martin Wiesner
Berlin, Germany