Safety, Efficacy and Preventative Effect of a Head Lice Product (X92001483) vs. Nix Creme Rinse (1% Permethrin).

NCT07660354 | Recruiting

• 1 other identifier: OYS012-0025
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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

Conditions

Lice; Head Lice

Keywords

Head Lice Treatment

Outcome Measures

Primary Outcomes (2)

• Preventative Effect

  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.

  14 days

• Maintenance of cure rate over time

  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.

  day 3, day 7, day 10, day 13 and day 14

Secondary Outcomes (5)

• Time to re-infestation

  14 days

• Number of live lice

  Day 0, day 3, day 7, day 10, days 13, day 14

• Local tolerability

  day 0, day 3, day 7, day 10, day 13 and day 14

• Scalp and skin irritation

  day 0, day 3, day 4, day 7, day 10, day 13 and day 14

• Adverse advents

  Day 0, day 3, day 7, day 10, day 13 and day 14

Study Arms (2)

Medical Device X92001483

EXPERIMENTAL

Treatment of subjects with head Lice with the standard of care product Nix Creme Rinse on day 0 and day 7, followed by intermediate application of the medical device (X92001483) with a physical mode of action applied every 3 days.

Device: Medical Device (X92001483)

Nix Cream Rinse (1% Permethrin)

NO INTERVENTION

Treatment of subjects with Head Lice with Nix Cream Rinse (1% Permethrin) with a physical mode of action on day 0 and day 7.

Interventions

Medical Device (X92001483) DEVICE

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.

Medical Device X92001483

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Gender: male / female.
• 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.
• Age ≥ 1 year of age at the time of enrollment.
• 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).
• 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.
• The subject is in good general health based on medical history.
• 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.
• 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.
• Have a single place of residence or agree to remain at the current residence for the duration of the study.
• Subject agrees not to additionally shampoo, wash, or rinse their hair or scalp for 24-hours post treatment.
• The subject agrees not to cut or chemically treat their hair while participating in the study.
• Subject agrees to follow all study instructions, including attending all follow-up appointments.

You may not qualify if:

• 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).
• Application of any topical medication of any kind on the hair or scalp for a period of 48 hours prior to the screening visit.
• 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.
• Known skin allergies, multiple drug allergies or multiple allergies to cosmetic products.
• History of allergy or hypersensitivity to active ingredients, or constituents of the investigational or comparator products.
• 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.
• Subjects with chronic scalp disorder.
• 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.
• Females who are pregnant or nursing.
• Hair longer than waist length.
• Subject suspected or known not to follow instructions
• Previous participation in this study or participation in any other investigational trial within the preceding 14 days.
• 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.
• The subject is an Oystershell employee or is an employee of a third-party organization involved in the study.
• People with dreadlocks or clips in hair that cannot be removed or a person who does not want to remove these.

Sponsors & Collaborators

• Oystershell NV: lead
• LSRN Research: collaborator

Study Sites (1)

LSRN

Maitland, Florida, 32751, United States

RECRUITING

MeSH Terms

Conditions

Lice Infestations

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Katie Shepherd

CONTACT

561-635-2884; katie@licesolutions.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Two-Arm, Randomized, Controlled, Investigator/Assessor-Blinded, Comparative Study

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)