A Study to Evaluate the Efficacy and Safety of a Leave-in Spray in Subjects With Head Lice Infestation

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of Vamousse Spray 'n' Go, compared to a 1% Permethrin control shampoo, in the treatment of head lice.

Detailed Description
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Effective methods for eradication of lice infestation are available however many are time consuming to use and require diligence; ineffective application of treatments has led to the spread of resistant strains. This is a post-marketing, prospective, open label, randomised controlled study to evaluate the safety and efficacy of Vamousse Spray 'n' Go in subjects infested with Pediculosis Capitis. The product contains a broad spectrum antiparasitic, which may have a unique mode of action, and has a simple and convenient application method. The primary objective of the study will explore whether treatment with Vamousse Spray 'n' Go is more effective in killing lice and eggs compared to a permethrin-based control product. The secondary objective of the study is to demonstrate the safety and local tolerability of Vamousse Spray 'n' Go in children ages 2 years plus. The planned sample size is 58 subjects, equally split between treatment and control groups. Subjects will receive the allocated product on day 0, with follow-up visits on days 2, 7 and 14. A repeat treatment will be administered on day 7 if live lice are still present.

Official Title
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Treatment of Infestation With Pediculus Humanus Capitis in the Community Using a leave-in Spray: A Prospective, Randomised Controlled Study

Conditions
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Pediculosis Capitis, Lice Infestations, Head Lice

Intervention / Treatment
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* Other: Vamousse Spray 'n' Go
* Drug: Nix Creme Rinse Lice Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have an active head lice infestation defined as: at least 1 live lice (adults and/or nymphs) present on the scalp and/or hair, as determined by a trained evaluator. Subjects must be at least two (2) years of age through 75 years of age, presenting with an active head lice infestation. Subject is male or female. Subject is in good general health based on medical history. Each subject must have an appropriately signed Informed Consent agreement. A caregiver must sign an Informed Consent agreement for children not old enough to do so. Children 6-17 years of age will be administered a child's Assent Form. The caregiver of a subject must be willing to allow all household members to be screened for head lice. If other household members are found to have an active head lice infestation, they must be willing and able to participate in receiving study product or Standard of Care. Subject agrees not to use any other form of lice treatments (commercial, community-anecdotal, or mechanical/manual) while participating in the study. Following application of the test product, subject agrees not to shampoo, wash or rinse their hair or scalp until 8-hour post-treatment time has been reached and documented. 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. Female subjects of childbearing potential must be willing to have a urine pregnancy test prior to inclusion in this study. Exclusion Criteria: History of irritation or sensitivity to Vamousse Spray 'n' Go or the components, pediculicides or hair care products. Presentation at the treatment site with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is >2, blisters, vesicles which, in the opinion of the investigative personnel or medical monitor, will interfere with safety and/or efficacy evaluations. Presentation at the treatment site with eczema or atopic dermatitis. Treatment for head lice (Over the Counter [OTC], home remedy and/or Prescription) in the last 30 days. Any condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol. Is receiving any other treatment which, in the opinion of the investigator or medical monitor, may interfere with the study results. Females (including caregivers who come in contact with the investigational product) who are pregnant, nursing or planning a pregnancy which could include household subjects. If a household has a pregnant female who has an active case of lice, the entire household is excluded from participation and provided Standard of Care. Household members of child-bearing potential, including subjects, and unwilling to use an adequate method of contraception for the duration of the study. Adequate methods of contraception include: abstinence, vasectomised partner, oral birth control pills, birth control injections or patches, intra uterine devices, condoms with a spermicidal jelly or a diaphragm with spermicidal jelly, surgical sterilisation. Subjects and/or caregivers will be considered non-child-bearing if the following has occurred: full hysterectomy or bilateral oophorectomy is considered surgically sterile. Tubal ligation is not considered equivalent to female sterilisation. Participation in a previous investigational drug study within the past 30 days. Does not understand the requirements for study participation and/or may likely exhibit poor compliance, in the opinion of the investigator. Does not have a known household affiliation with their household members (i.e., do not stay in one household consistently, sleeping at one place several nights and then at another place or location). Household is defined as living in a shared area or space (for example the same house of apartment unit).

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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
Interventional Model Description: Parallel group design with participants randomised 1:1 to Vamousse Spray 'n' Go or 1% Permethrin control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vamousse Spray 'n' Go<br>Clinical staff will apply Vamousse Spray 'n' Go during the baseline visit (Day 0) to fully coat the hair and scalp. The treatment will be left on for 8 hours, then standard at home shampoo will be used and rinsed off with warm water, followed by combing. At day 7, if live lice are still present, a repeat treatment will be administered. | Other: Vamousse Spray 'n' Go<br>* Pediculicide for topical application, active ingredient Natrum Muriaticum 2X (HPUS).<br>|
| Active Comparator: Nix Creme Rinse Lice Treatment<br>During the baseline visit (Day 0) clinical staff will first shampoo the hair and scalp using regular shampoo. They will then thoroughly rinse and towel dry the hair and scalp, and allow hair to air dry for a few minutes. Staff will shake Nix Creme Rinse Lice Treatment (1% permethrin lotion) well before applying, they will then proceed to thoroughly wet the hair and scalp with the lotion, being sure to cover the areas behind the ears and on the back of the neck. After allowing the lotion to remain in place for 10 minutes, they will rinse the hair and scalp thoroughly and dry with a clean towel. At day 7, if live lice are still present, a repeat treatment will be administered. | Drug: Nix Creme Rinse Lice Treatment<br>* 1% permethrin lotion for topical application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects in a study group who are completely lice free. | Lice free is defined as no live lice, adults or nymphs. | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in total number of live adult lice and nymphs from the baseline count in each study group. |  | Day 14 |