Head louse infestation Infections and Infestations Pediculosis due to Pediculus humanus capitis
Conditions
Interventions
Fulltec Anti-Lice Protector shampoo applied to pre-washed and towel dried hair for 15 minutes followed by rinsing, with a repeat treatment 8 days later.
Sponsors
Fulltec AG (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, aged 2 years and over with no upper age limit 2. People who upon examination, are confirmed to have live head lice 3. People 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. People who will be available for follow-up visits by study team members over the 16 days following first treatment
Exclusion criteria
Exclusion criteria: 1. People with a known sensitivity to nuts, coconut, or any of the ingredients in Fulltec Anti-Lice Protector 2. People with a secondary bacterial infection of the scalp (e.g. impetigo) or who have an active long-term scalp condition (e.g. psoriasis of the scalp) 3. People who have been treated with other head lice products within the previous two weeks 4. People who have been treated with the antibiotics co-trimoxazole or trimethoprim within the previous four weeks, or who are currently taking such a course 5. Pregnant or nursing mothers 6. People who have participated in another clinical study within one month before entry to this study 7. People who have already participated in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cure of infestation, defined as no evidence of head lice, assessed between completion of the second application of treatment on day 8 and day 16 (the first treatment being applied on day 0). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety of the product monitored by observation for adverse events on days 0, 1, 8, and 16 of the study 2. Acceptability of the product, assessed by a questionnaire at day 1 | — |
Countries
United Kingdom
Outcome results
None listed