Infestation with head lice (Pediculus capitis) Infections and Infestations Pediculosis and phthiriasis
Conditions
Interventions
The participants will be randomly allocated to the two groups in equal numbers.
Group 1: Participants will be treated with Lyclear® spray away (ParaNix® spray
topical) containing:
Active: Illicium verum (star anise) oil, caprylic/capric triglyceride (fractionated coconut oil derivative), cananga odorata (ylang-ylang) oil
Excipients: Propan-2-ol
Group 2:
Sponsors
Omega Pharma N.V. (Belgium)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, aged 2 years and over with no upper age limit 2. Participants who upon examination, are confirmed to have live head lice 3. Participants who give written informed consent, or if the participant is under 16 years of age whose parent/guardian gives written informed consent to participate in the study 4. Participants who will be available for home visits by Medical Entomology Centre (MEC) study team members over the 14 days following first treatment
Exclusion criteria
Exclusion criteria: 1. Participants with a known sensitivity to any of the ingredients in Lyclear® spray away (ParaNix® spray) or Infectopedicul® lotion 2. Participants with asthma or a similar respiratory condition 3. Participants with a secondary bacterial infection of the scalp (e.g. impetigo) or who have a long term scalp condition (e.g. psoriasis of the scalp) 4. Participants who have been treated with other head lice products within the previous two weeks 5. Participants who have bleached hair, or hair that has been colour treated or permanently waved within the previous four weeks (wash in/wash out colours are acceptable) 6. Participants who have been treated with the antibiotics co-trimoxazole or trimethoprim within the previous four weeks, or who are currently taking such a course 7. Pregnant or nursing mothers 8. Participants who have participated in another clinical study within 1 month before entry to this study 9. Participants who have already participated in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number of participants with no evidence of active head louse infestation 14 days (+/- 1 day) after enrolment 2. Safety, assessed 2 and 7 days after the first treatment, and 2 and 5 days after the second treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Ease of application (investigator opinion), assessed using a questionnaire on the same day as the first treatment 2. Participant acceptability, assessed using a questionnaire 5 days after the second treatment | — |
Countries
United Kingdom
Outcome results
None listed