Lice; Head Lice
Conditions
Keywords
Head Lice Treatment
Brief summary
To compare the safety, effectiveness, and preventive benefits of a medical device (X92001483) against Nix Cream Rinse (1% Permethrin) in people with head lice
Detailed description
Compare Safety, Efficacy and preventative effect of a medical device with a physical mode of action against Nix Cream Rinse (1% Permethrin) in Subjects with Head Lice in a two-arm, randomized, controlled, Investigator/Assessor-blinded comparative study.
Interventions
DEVICEMedical Device (X92001483)
Treatment of subjects with Head Lice with a medical device (X92001483) with a physical mode of action on day 0, day 7, day 10, day 13 and day 14.
Sponsors
Oystershell NV
LSRN Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
A Two-Arm, Randomized, Controlled, Investigator/Assessor-Blinded, Comparative Study
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Gender: male / female. 2. The subject or his/her parent/legal guardian (from age 12-17) must give written informed consent (after having been informed orally and by written text about the benefits and potential risks of the trial, as well as information regarding the insurance, taken out to cover the subjects participating in the study). A caregiver must sign an informed consent agreement for children not old enough to do so. Children aged 6-11 years of age will be administered a child's assent form. The subject or his/her parent/legal guardian must be capable of understanding and providing written informed consent. 3. Age ≥ 1 year of age at the time of enrollment. 4. Subject agree to not use any other anti-lice or preventative treatment or medicated hair grooming products for the duration of the study (through last visit day- Day 14). 5. Subject must have an active head lice infestation defined as at least 5 live lice (adults and/or nymphs) and 5 live nits based on magnified observations, present on the scalp and/or hair, as determined by a trained evaluator. 6. The subject is in good general health based on medical history. 7. Female subjects of childbearing potential must have a negative pregnancy test at screening and agree to use a reliable method of birth control (as described in section 7.8) during duration of the study. 8. The parent or legal guardian of a child subject must consent to the screening of other household members for head lice. If additional household members are found to have head lice and meet eligibility criteria, they must be enrolled in the study for all household members to qualify for participation. 9. Have a single place of residence or agree to remain at the current residence for the duration of the study. 10. Subject agrees not to additionally shampoo, wash, or rinse their hair or scalp for 24-hours post treatment. 11. The subject agrees not to cut or chemically treat their hair while participating in the study. 12. Subject agrees to follow all study instructions, including attending all follow-up appointments.
Exclusion criteria
1. Application of any form of head lice treatment, whether prescription or over-the counter (OTC), or home remedy for 14 days prior to their screening visit (Visit 1). 2. Application of any topical medication of any kind on the hair or scalp for a period of 48 hours prior to the screening visit. 3. Use of systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results. 4. Known skin allergies, multiple drug allergies or multiple allergies to cosmetic products. 5. History of allergy or hypersensitivity to active ingredients, or constituents of the investigational or comparator products. 6. Subject 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 investigational product. 7. Subjects with chronic scalp disorder. 8. Subject or his/her legal guardian who, in the opinion of the investigative personnel, do not understand the subject requirements for study participations and/or may be likely to exhibit poor compliance with the required visits. 9. Females who are pregnant or nursing. 10. Hair longer than waist length. 11. Subject suspected or known not to follow instructions 12. Previous participation in this study or participation in any other investigational trial within the preceding 14 days. 13. The subject is directly affiliated to the investigator site personnel and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 14. The subject is an Oystershell employee or is an employee of a third-party organization involved in the study. 15. People with dreadlocks or clips in hair that cannot be removed or a person who does not want to remove these. 16. Hair that is too difficult to work with as assessed by the study staff. 17. Families excluded where lice exist however a family member decline enrollment in the study. 18. Subjects who are receiving, or are expected to receive, any antibiotic therapy during the study period will be excluded. 19. No more than one working male subject per household may be excluded from evaluation if determined to be lice free by self-report or caregiver observation. 20. All household members of the subject, other than excluded male adult, must be screened for head lice by a certified head lice professional. If additional household members are found to have head lice and meet the study criteria, they will be referred to LSRN Research and enrolled in study. If a household member declines enrollment, all family members will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preventative Effect | 14 days | Determin whether subjects treated with the medical device X92001943 after treatment with Nix Creme Rinse maintain a higher cure rate at the end of the study compared with subjects treated only with Nix Creme Rinse. |
| Maintenance of cure rate over time | day 3, day 7, day 10, day 13 and day 14 | To assess the maintenance of cure over time: To compare cure rates between subjects treated with Nix Creme Rinse and the medical device X92001483 at interim visits in order to evaluate the presence and persistence of the preventive effect of the investigational product relative to standard of care product (Nix creme rinse) alone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to re-infestation | 14 days | Characterize the time to re-infestation in each treatment group |
| Number of live lice | Day 0, day 3, day 7, day 10, days 13, day 14 | To compare the number of live lice detected at each assessment across treatment groups. |
| Local tolerability | day 0, day 3, day 7, day 10, day 13 and day 14 | To evaluate the local tolerability of the standard of care product and investigational product, as measured by subject reported symptoms (eg: burning, paraesthesia, pruritus) following application. |
| Scalp and skin irritation | day 0, day 3, day 4, day 7, day 10, day 13 and day 14 | To evaluate scalp and skin irritation by study staff (secondary infection, erythema, excoriation) following product application. |
| Adverse advents | Day 0, day 3, day 7, day 10, day 13 and day 14 | To record and characterize all treatment-emergent adverse events occurring during the study. |
Countries
United States
Contacts
CONTACTKatie Shepherd
Outcome results
None listed