Head louse infestation Infections and Infestations Head-louse infestation
Conditions
Interventions
All participants will be treated using 4% dimeticone gel on two occasions a week apart before starting on study treatments to eliminate any current infestation.
1. 1% 1,2-Octanediol solution
2. Plac
Sponsors
Thornton & Ross Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females attending school with no upper age limit, although they must be the youngest qualifying member of the household 2. People who are confirmed to be at risk of infestation with 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 home visits by study team members over the 14 weeks of the study
Exclusion criteria
Exclusion criteria: 1. People with a known sensitivity to any of the ingredients in Octanediol 1% Solution, Hedrin Once liquid gel or the placebo leave in conditioner preparation 2. People 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) 3. Pregnant or nursing mothers 4. People who have participated in another clinical study within 1 month before entry to this study 5. People who have already participated in this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of effectiveness of Octanediol 1% Solution, applied at least twice each week, compared with placebo to prevent or limit establishment of head louse infestation as measured by the time to first infestation with head lice during either of the six week periods on treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Whether an infestation occurred during the six week period 2. The number of infestations occurring during the period, the safety of the product | — |
Countries
United Kingdom
Outcome results
None listed