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

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alliance Pharmaceuticals
• Collaborator: South Florida Family Health and Research Centers

Criteria

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).