Head Lice
Conditions
Brief summary
The purpose of this study is to compare the efficacy and safety of an insecticide-free head lice product with that of a pyrethrum-based product.
Detailed description
The primary objective of the study was to compare the safety and efficacy of X92001327 versus RID in subjects with head lice. The subjects received a single application on Day 0 of either X92001327 or RID shampoo based on the randomization schedule. A repeat application of the test product was administered on Day 7. Subjects visited the clinic four times: on Day 0, Day 1, Day 7 and Day 10.
Interventions
OTHERX92001327
OTHERRID shampoo
Sponsors
Oystershell NV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female over the age of 1 at the time of signing the informed consent or giving assent * Have an active head lice infestation of at least 5 live lice and 5 viable nits * subject must be capable of understanding and providing written informed consent * agree not to use any other pediculicides or medicated hair grooming products for the duration of the study * agree not to use a lice comb during the study * the parent or guardian of a child must be willing to have other family members screened for head lice. * have a single place of residence
Exclusion criteria
* used any form of head lice treatment whether prescription or over the counter or home remedy at least four weeks prior to their screening visit * used any topical medication of any kind for a period of 48 hours prior to the screening visit * individuals on systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results * has a history of allergy or hypersensitivity to ragweed, hydrocarbons, sesame oil, perfume or any ingredient in either test product * individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel will interfere with the evaluation of the test product * individuals who, in the opinion of the investigative personnel do not understand the subject requirements for study participation and/or may be likely to exhibit poor compliance with the required visits * females who are pregnant or nursing * patients that have taken trimethoprim or a combination of sulfamethoxazole at evaluation or during the previous 4 weeks * subjects with hair longer than mid back
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects lice free at the end of the study (Day 10) | Day 10 | Primary objective of this study was the cure rate (%) in each treatment group, following two applications (day 0 and day 7) of the specific test product, as assessed on the last evaluation visit (day 10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects lice free at each of the intermediate evaluations (Day 1, Day 7) | Day 1, Day 7 | Secondary outcome involved the cure rate (%) in each treatment group, following one application of the specific test product, as assessed 24h post treatment (day 1) and on day 7 (prior to the second treatment). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Eye irritation | Day0, Day 1, Day7, Day10 | As part of the evaluation of the safety profile of both test products, eye irritation has been evaluated at day 0 (prior to and after first treatment), day 1 (24h after the first treatment), day 7 (prior to and after second treatment) and day 10, respectively. |
| Scalp condition | Day0, Day1, Day7, Day10 | As part of the evaluation of the safety profile of both test products, scalp condition has been evaluated at day 0 (prior to and after first treatment), day 1 (24h after the first treatment), day 7 (prior to and after second treatment) and day 10, respectively. |
| Adverse events collection | Day 0, Day1, Day7, Day10 | Adverse events have been collected from the initial application of test product until completion of the final follow-up visit (day 10). For any adverse event, date of onset, intensity, seriousness and causal relationship to the study treatment have been recorded. |
Countries
United States
Outcome results
None listed