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

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

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.

This is a Study to Evaluate the Safety and Efficacy of Alliance Pharmaceutical Product in Subjects Infested with Pediculosis Capitis. The subject population includes healthy male and female subjects aged 2 years and up who are infested with Pediculus humanus capitis. Household members infestation with an active head lice, defined as at least 1 live louse (adult and/or nymph) present on the scalp and/or hair as determined by a trained evaluator, will receive treatment with study product at baseline.

The planned overall sample size for this clinical trial is approximately n=58 subjects, equally divided between treatment and control groups. Potential subjects will be screened for eligibility and if eligible to participate, their infestation level will be rated. Eligible subjects at each infestation level will be assigned alternately to the treatment or control group to ensure that the two groups have approximately equal representations of infestation severity levels. Level of infestation will be rated as heavy, moderate or light described by how quickly lice were found during combing: heavy infestation = >1 louse with one stroke of the comb; moderate infestation =1 louse with one stroke of the comb; light infestation = first louse found only after several strokes of the comb.

Randomly assign subjects to treatment or control group based on infestation severity alternation system (i.e., randomly assign pairs of equal severity levels to treatment and control groups, a form of stratified random sampling) to achieve balanced representation of severity in the two groups.

After assignment to a study group, each eligible subject will receive the application of either the Alliance Pharmaceutical Product Vamousse Spray 'n' Go drug or the Permethrin-based control drug. Infested household members will be treated with the Vamousse Spray 'n' Go or Permethrin lotion on-site (i.e., the household members should be assigned to the same treatment as the index case). During the baseline visit (Day 0), the Investigator and clinical staff members will record subject's demographics; elicit informed consent; obtain medical history; review concomitant medication to identify any prohibited therapies the subject may be receiving; collect vital signs; conduct visual assessment of head lice, specifically counting live lice and nits with stages noted, using a 15 inch led 5x magnifying procedure lamp and if needed for confirmation, laboratory microscopes; perform physical examination; assess local skin/ scalp irritation; assess ocular irritation; perform urine pregnancy test on females; and conduct an adverse event assessment.

At day 7, if live lice are still present, a repeat treatment will be administered. After day 7 if a subject reports clear signs of infestation ( i.e., the presence of live lice), they will be regarded as a treatment failure and they will be offered treatment with an alternative product (viz., Vamousse Mousse ) by clinical staff.

For the treatment group, Clinical staff will apply Vamousse Spray 'n' Go to fully coat dry hair and scalp, avoiding the eyes and mucus membranes. The Treatment will be left on the hair and scalp for 8 hours, then standard at home shampoo and rinsed off with warm water, followed by combing. The Treatment spray bottle is intended for a single use although it contains a sufficient quantity for two treatments. All household members will be instructed on an overall lice management program, which includes:

• Wash (in hot water) or dry-clean all recently worn clothing, hats, used bedding and towels.
• Wash (in hot water) personal care items such as combs, brushes and hair clips.
• Record time and date product shampoo/rinse 8 hours post treatment

For the control group, 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. Shaking the permethrin lotion well before applying, they will proceed to thoroughly wet the hair and scalp with the permethrin lotion, being sure also 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 then rinse the hair and scalp thoroughly and dry with a clean towel.

The site will provide Subject with lice management instructions. Subjects will return for post-baseline visits assessments at Day 2, Day 7, and Day 14.

Day 2: The Investigator and medical staff will collect medical history, collect vital signs, perform physical examination, scalp irritation assessment, ocular irritation assessment and adverse events assessment, perform a visual assessment for the presence or absence of head lice, (Lice will be counted, each stage examined and noted live or dead; 15in led 5x magnifying procedure lamp or laboratory microscopes are used for confirmation if needed, Without clipping hair strands, nits will also be examined, each stage examined and noted hatched or unhatched), and adverse events assessment Urine pregnancy testing will be performed on each Visit, with interim visits confirming pregnancy has not occurred through questioning participating subject and legal guardian.

Day 7: The Investigator and medical staff will collect medical history, collect vital signs, perform a physical examination, assess scalp irritation, assess ocular irritation and adverse events, perform a visual assessment for the presence of head lice (lice will be counted, each stage identified, and noted live or dead; 15in led 5x magnifying procedure lamp or laboratory microscopes will be used for confirmation if needed; without clipping hair strands, nits will also be examined, each stage examined, and noted hatched or unhatched). Urine pregnancy testing of females will be performed on each visit, with interim visits confirming pregnancy has not occurred through questioning participating subject and legal guardian. If, at day 7, live lice are still present, a repeat Vamousse Spray 'n' Go or Permethrin (depending on study group) shampoo treatment will be administered.

Day 14: The Investigator and medical staff will collect medical history, concomitant and prohibited medication review, perform vital signs, urine pregnancy testing if applicable, perform physical examination, record local application site reactions, ocular irritation assessment, perform a visual assessment for the presence of head lice (lice will be removed, counted, each stage examined and noted live or dead; 15 inch led 5x magnifying procedure lamp or laboratory microscopes are used for confirmation; nits will also be removed by clipping hair strands, examined, each stage counted, and noted as hatched or unhatched) and adverse events assessment. By day 14 if a subject reports clear signs of infestation (i.e., the presence of live lice) they will be regarded as a treatment failure and will be offered treatment with an alternative product (Vamousse Mousse) by clinical staff.

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 Nature Muriaticum 2X (HPUS) or 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 and atopic dermatitis 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, 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.
• Subject 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).