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

Study Overview
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Brief Summary
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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).

Detailed Description
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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). The study will be performed in subjects ≥2 year of both genders with confirmed diagnosis of head lice infestation. To support safety, local and global tolerability, skin and ocular irritation will be assessed and adverse events (AEs) will be registered.

Official Title
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A Randomized, Controlled, Investigator-Assessor Blinded, Comparative Study to Evaluate the Safety and Efficacy of a Water-Soluble Head Lice Suffocation Product (X92001666) vs RID Shampoo (Pyrethrin) in Subjects With Head Lice

Conditions
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Head Lice, Pediculosis Capitis

Intervention / Treatment
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* Device: X92001666
* Other: RID shampoo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gender: male / female. Women of childbearing potential is a premenopausal female that is anatomically and physiologically capable of becoming pregnant following menarche. Female subjects: are women of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive gel or are women of non-childbearing potential, defined as: women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), or women who are ≥60 years of age. 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. No more than one working male per household may be excluded from evaluation if he is assessed as being lice free by himself or caregiver. Subject agrees to follow all study instructions, including attending all follow-up appointments. Agree to not use any other pediculicides or medicated hair grooming products for the duration of the study (through Day 10 visit). The parent or legal guardian of a child must be willing to have other family members screened for head lice. If other household members are found to have head lice and are eligible, they must be either enrolled in the study OR receive the standard of care at the site and in the same manner as study participants. Have a single place of residence. The subject or his/her parent or 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 details of the insurance taken out to cover the subjects participating in the study Subjects must agree to not use any other ant-lice treatment for the duration of 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. Females who are pregnant or nursing. Hair longer than mid-back. Subject suspected or known not to follow instructions Previous participation in this study or participation in any other investigational trial within the preceding 30 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 organizations involved in the study.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test product<br>Water-based lotion (internal code (X92001666) | Device: X92001666<br>* the X92001666 product is a lotion to be applied on dry hair for 15 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.<br>* Other names: Test product;|
| Active Comparator: Reference<br>Commercial, pyrethrin-based shampoo (RID shampoo) | Other: RID shampoo<br>* Active Comparator: RID shampoo The RID shampoo is to be applied on dry the hair for 10 minutes and then rinsed out with water. the product is to be applied on Day 0 and repeated again on Day 7.<br>* Other names: Reference;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Including All Baseline Infestations). | Clinical efficacy is reflected by the % of subjects that are lice-free after 2 topical applications (at day 0 & day 7 respectively) of the test product. In this analysis, all baseline infestations (mild, moderate, severe) have been included. Assessment is performed at study end (visit 4, day 10). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs | Day10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects That Are Lice-free After 2 Treatments With Reference Product (Including All Baseline Infestations). | Clinical efficacy is reflected by the % of subjects that are lice-free after 2 topical applications (at day 0 & day 7 respectively) of the reference product. In this analysis, all baseline infestations (mild, moderate, severe) have been included. Assessment is performed at study end (visit 4, day 10). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs | Day 10 | 
| Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Only Mild and Moderate Baseline Infestations). | The % of subjects with a mild (5-9 lice and/or nymphs) and moderate (10-24 lice and/or nymphs) baseline infestation that are lice-free after two topical treatments (day 0 & day 7) with the test product; assessed at study end (visit 4; day 10). | Day 10 | 
| Number of Subjects That Are Lice-free After 2 Treatments With Reference Product (Only Mild and Moderate Baseline Infestations). | The % of subjects with a mild (5-9 lice and/or nymphs) and moderate (10-24 lice and/or nymphs) baseline infestation that are lice-free after two topical treatments (day 0 & day 7) with the reference product; assessed at study end (visit 4; day 10). | Day 10 | 
| Number of Subjects That Are Lice-Free After 1 Treatment With Test Product (All Baseline Infestations). | The % of subjects that are lice-free after one topical treatment with the test product (assessment 24h post treatment), considering all baseline infestations (mild, moderate, severe). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs | Day 1 | 
| Number of Subjects That Are Lice-free After 1 Treatment With Reference Product (All Baseline Infestations). | The % of subjects that are lice-free after one topical treatment with the reference product (assessment 24h post treatment), considering all baseline infestations (mild, moderate, severe). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs | Day 1 | 
| Effect of Both Investigational Treatments on Pruritus (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator. | The occurrence and degree of pruritus is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: the scalp does not itch; Mild: occasional episodes of itching, not bothersome; Moderate: frequent, several times a day, bothersome; Severe: nearly constant, frequent scratching, very bothersome. | Day 0, Day 1, Day 7, Day10 | 
| Effect of Both Investigational Treatments on Scalp Excoriation (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator. | The occurrence and degree of scalp excoriation (breaking of the skin, usually caused by scratching) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no broken skin on the scalp; Mild: one or two areas on the scalp on which skin is broken; Moderate: more than two separate areas of the scalp with broken skin but not generalized across the scalp; Severe: widespread breaking of the skin involving most of the scalp. | Day 0, Day 1, Day 7, Day10 | 
| Effect of Both Investigational Treatments on Paraesthesia (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator. | The occurrence and degree of paraesthesia (tingling or prickling sensation) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no tingling or prickling sensation; Mild: occasional tingling or prickling sensation; Moderate: frequent tingling or prickling sensation; Severe: nearly constant tingling or prickling sensation | Day 0, Day 1, Day 7, Day10 | 
| Effect of Both Investigational Treatments on Skin Erythema (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator. | The occurrence and degree of skin erythema (redness of the scalp) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no redness of the scalp; Mild: faint, barely perceptible erythema with limited distribution; Moderate: diffuse pink areas of scalp are readily visible; Severe: large areas of the scalp are red. | Day 0, Day 1, Day 7, Day10 | 
| Effect of Both Investigational Treatments on Pyroderma (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator. | The occurrence and degree of pyroderma (sores filled with clear fluid, pus or crusting) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no lesions visible on the scalp; Mild: one or two lesions visible with crusting or other evidence of infection; Moderate: presence of more than two lesions with crusting or other evidence of infection, but not generalized across the scalp; Severe: lesions with crusting or other evidence of infection, involving most of the scalp. | Day 0, Day 1, Day 7, Day10 | 
| Effect of Both Investigational Treatments on Eye Irritation, as Assessed by a Blinded Clinical Investigator. | The occurrence and degree of eye irritation (stinging, burning sensation, and/or pain) is rated by the blinded clinical investigator at each visit, using the following scores: none (best outcome), mild, moderate, and severe (worst outcome). None: no stinging, burning or pain Mild: slight mild stinging, burning or pain Moderate: moderate stinging, burning or pain Severe: severe stinging, burning or pain | Day 0, Day 1, Day 7, Day10 | 
| Global Tolerability, Evaluated at Study End (Visit 4, Day 10) | Global tolerability is defined as the general well-being and comfort of the subjects. This parameter is assessed at day 10 in subjects, treated with either test product or reference product, respectively. The subject is asked to score his general feeling at study end and must provide a justification for his/her answer. Scoring was performed as follows: very good (best case), good, moderate, or poor (worst case). | Day 10 |