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

NCT05565820 | Completed Phase 4 Results FDA Drug

• 1 other identifier: ALLI010-0021
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediculosis Capitis; Lice Infestations; Head Lice

Keywords

Phthiraptera; Pediculus humanus Capitis; Pediculidae; Parasitic Diseases; Human Head Louse; Pediculi; Nits; Homeopathy; Homeopathic Pharmacopoeias; Homeopathic Formularies; Insecticides; Parasitology

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Who Are Completely Free of Live Lice

  The total numbers of subjects in each group free of live lice at Days 2, 7, and 14, where 'live lice free" is defined as no presence of live adult or nymph lice. Zero subjects in each group were free of live lice at baseline. Since the two groups differed substantially in size, the numbers of live lice free subjects in each group at Days 2, 7, and 14 were transformed for analytical purposes to proportions of the respective group's participant totals on the respective days in order to achieve a metric that reflects commensurate degrees of difference between the two groups.

  2, 7, and 14 days from baseline

Secondary Outcomes (1)

• Proportion of Change in Total Number of Live Adult Lice and Nymphs From the Baseline

  2, 7, and 14 days from baseline

Study Arms (2)

Vamousse Spray 'n' Go

EXPERIMENTAL

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

Nix Creme Rinse Lice Treatment

ACTIVE COMPARATOR

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

Interventions

Vamousse Spray 'n' Go OTHER

Pediculicide for topical application, active ingredient Natrum Muriaticum 2X (HPUS).

Vamousse Spray 'n' Go

Nix Creme Rinse Lice Treatment DRUG

1% permethrin lotion for topical application.

Nix Creme Rinse Lice Treatment

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Alliance Pharmaceuticals: lead
• South Florida Family Health and Research Centers: collaborator

Study Sites (1)

South Florida Family Health and Research Centers, LLC.

Miami, Florida, 33186, United States

Location

Related Publications (2)

• Barker SC, Burgess I, Meinking TL, Mumcuoglu KY. International guidelines for clinical trials with pediculicides. Int J Dermatol. 2012 Jul;51(7):853-8. doi: 10.1111/j.1365-4632.2011.05446.x.

  PMID: 22715834 BACKGROUND

• Birkemoe T, Lindstedt HH, Ottesen P, Soleng A, Naess O, Rukke BA. Head lice predictors and infestation dynamics among primary school children in Norway. Fam Pract. 2016 Feb;33(1):23-9. doi: 10.1093/fampra/cmv081. Epub 2015 Oct 28.

  PMID: 26511728 BACKGROUND

Related Links

• Head Lice Infestation: Developing Drugs for Topical Treatment - Guidance for Industry. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research October 2016

MeSH Terms

Conditions

Lice Infestations; Parasitic Diseases

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: R&D Director
• Organization: Alliance Pharmaceuticals

medaffairs@allianceph.com

01249 466966

Study Officials

• Susel L Gonzalez Acosta, APRN

  South Florida Family Health and Research Centers

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel group design with participants randomised, Randomly assign subjects to treatment or control group based on infestation severity alternation system, to Vamousse Spray 'n' Go or 1% Permethrin control.

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: December 15, 2022
• Primary Completion: March 12, 2023
• Study Completion: March 12, 2023
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)