Head louse infestation Infections and Infestations Pediculosis due to Pediculus humanus capitis
Conditions
Interventions
Group A Liceko®: The product will be applied directly to dry hair. Sufficient product will be applied to saturate the hair and scalp. The product will be left in place for 20 minutes before being sham
Sponsors
Panin S.R.L (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, aged 6 months 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 14 days following first treatment
Exclusion criteria
Exclusion criteria: 1. People with a known sensitivity to any of the ingredients in Liceko ® or Nix® / Lyclear® 1% permethrin creme rinse, pyrethroid insecticides, or plants related to dandelions or chrysanthemums. 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 bleached hair, or hair that has been permanently waved within the previous four weeks 5. 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 6. Pregnant or nursing mothers 7. People who have participated in another clinical study within one month before entry to this study 8. 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 7 and day 14 (the first treatment being applied on day 0). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of the efficacy of Liceko® with that of Nix® / Lyclear® crème rinse and to identify superiority of one product over the other if appropriate. 2. Safety of the products monitored by observation for adverse events on days 0, 1, 6, 7, 9, and 14 of the study | — |
Countries
United Kingdom
Outcome results
None listed