A Randomised, Assessor Blinded "Proof of Concept" (Phase IIa) Clinical Study to Assess the Efficacy and Safety of Nice 'n Clear Head Lice Lotion in the Treatment of Head Lice
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 47
- Locations
- 2
- Primary Endpoint
- Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing
Study Overview
Brief 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
Detailed Description
Neem oil has had a long reputation for killing a wide range of insects, including head lice. Several products are marketed with this oil as a named active ingredient, e.g. Nice 'n Clear neem-based conditioning lotion. This product was developed as an aid to combing out head lice for eliminating infestation but it has been considered possible that the neem oil could act to kill lice and inhibit their eggs from hatching.
This study was designed to compare use of Nice 'n Clear neem-based conditioning lotion when used with two different types of comb. One arm of the study was planned so that participants were combed using a plastic louse detection and removal comb (wet combing with conditioner method), in which it was expected the combing process would play a major role in efficacy. The other arm was planned so that participants were combed using a regular grooming comb, which would normally have little effect for removing head lice from the hair.
Comparison of the efficacy outcome in the two groups would determine whether the Nice 'n Clear neem-based conditioning lotion exhibited any effect to eliminate infestation independent of the combing
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
Number of Participants Free From Head Louse Infestation as Assessed by Detection Combing
Time Frame: 15 days
Recruitment at Day 0. Success of treatment = No lice present at Day 14 and no lice present at Day 10
Secondary Outcomes
- Difference in Number of Participants Free From Head Louse Infestation According to Comb Type Used(15 days)
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0(15 days)
Investigators
Ian F Burgess
Director
Medical Entomology Centre