CompletedNot Applicable

A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product.

United States70 participantsStarted 2018-03-07

Plain-language summary

The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo).

Who can participate

Age range2 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Gender: male / female.
✓. Women of childbearing potential is a premenopausal female that is anatomically and physiologically capable of becoming pregnant following menarche.
✓. Age: ≥ 2 year of age at the time of enrollment.
✓. Subject must have an active head lice infestation defined as at least 5 live lice (adults and/or nymphs) and 5 apparently live nits, present on the scalp and/or hair, as determined by a trained evaluator.
✓. Subject is in good general health based on medical history.
✓. The subject or his/her parent/legal guardian must give written informed consent, after having been oral and written informed about 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 ages 6-18 years of age will be administered a child's assent form. Subject or his/her parent/legal guardian must be capable of understanding and providing written informed consent.
✓. Following application and rinsing of the test products, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24-hour post treatment evaluation has been completed.
✓. The subject agrees not to cut or chemically treat their hair while participating in the study.

Exclusion criteria

✕. Application of any form of head lice treatment, whether prescription or over-the-counter (OTC), or home remedy for 30 days prior to their screening visit (Day 1).
✕. Application of any topical medication of any kind on the hair 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 ragweed, active ingredients or constituents of the test 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 test 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.

What they're measuring

Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Including All Baseline Infestations).

Timeframe: Day10

Trial details

NCT IDNCT03617926

SponsorOystershell NV

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-06-30

Results submitted2021-09-23

View on ClinicalTrials.gov More Head Lice trials