Phase 2
N=47
Neem Lotion With Combing for Lice
Pediculoses · Head Lice
Bottom Line
View on ClinicalTrials.gov: NCT02974088 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing — 23; 22 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Neem-based lotion plus louse comb (Device); Neem-based lotion plus grooming comb (Device)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Medical Entomology Centre
- Primary completion
- Aug 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing |
23; 22 | — |
| SECONDARY Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used |
23; 22 | — |
| SECONDARY Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 |
— | — |
Summary
This was a Phase IIa randomised, assessor blinded, parallel group study in which half the participants were treated with Nice 'n Clear neem-based conditioning lotion plus combing with a head louse detection and removal comb and the remainder were treated with Nice 'n Clear plus combing with a normal grooming comb
Eligibility Criteria
Inclusion Criteria
- Males and females who are found to have an active head louse infection, i.e. the presence of live lice. Detection combing will be done with a fine-toothed plastic detection comb, until at least one louse is found.
- People who give written informed consent and/or, if the participant is below 16 years of age, whose guardian gives written informed consent to participate in the study. Assent/verbal assent forms will be required for those between the ages of 4 and 16 years of age. There is no maximum age limit.
- Participants must be available for the duration of the study i.e. 15 days.
Exclusion Criteria
- People who have been treated with other head louse products within the previous 2 weeks (14 days).
- People who have undergone a course of antibiotic treatment using Cotrimoxazole, Trimethoprim or Septrin within the previous 4 weeks, or who are currently taking such a course.
- People whose hair has been bleached, colour treated, or semi-permanently waved within the previous 2 weeks, this includes the use of semi-permanent colouring agents. Home use wash in/wash out colouring agents are acceptable.
- People who have taken part in another clinical study within 4 weeks prior to entry to this one.
- Females who are pregnant or breast-feeding.
- Participants who have already taken part in this study.
- People who have a known allergy to any of the ingredients of Nice 'n Clear Lotion (including allergy to Paraben preservatives)
- Children under 6 months of age.
Data sourced from ClinicalTrials.gov (NCT02974088). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.