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

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.