NCT04878276RecruitingNot Applicable
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)
Infectopharm Arzneimittel GmbH26 sites in 1 country240 target enrollmentStarted: May 17, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 240
- Locations
- 26
- Primary Endpoint
- Freedom from infestation
Study Overview
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 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 6 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Freedom from infestation
Time Frame: Day 17 to 21
Freedom from infestation of live head lice at the final examination (V2)
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (26)
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