Clinical Trials/NCT05378477

NCT05378477

Recruiting

N/A

Randomized, Controlled, Assessor-Blinded, Comparative Study to Evaluate Safety & Efficacy of a New Suffocation Product vs an Oligodecene-based Suffocation Product, 1% Permethrin & a Fatty Acids-based Product in Subjects With Head Lice.

Oystershell NV1 site in 1 country220 target enrollmentJanuary 17, 2022

ConditionsHead Lice Pediculosis Capitis

InterventionsX92001752 RID Super Max Solution Nix Crème Pouxit Végétal

DrugsNix Crème

Overview

Phase: N/A
Intervention: X92001752
Conditions: Head Lice
Sponsor: Oystershell NV
Enrollment: 220
Locations: 1
Primary Endpoint: Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Including All Baseline Infestations).
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The present study is set-up to compare in vivo clinical performance and safety of the test product (X92001752) versus 3 other pediculicides (2 medical devices and 1 conventional pesticide).

Detailed Description

The present study is set-up to compare in vivo clinical performance and safety of the test product versus a) RID Super Max Solution (oligodecene oil), Nix crème (1% permethrin), and Pouxit Végétal (fatty acid salts). 220 subjects (n=55 per treatment group) with confirmed diagnosis of head lice infestation will be included. To support safety, local and global tolerability, skin and ocular irritation will be assessed and adverse events (AEs) will be registered.

Registry

clinicaltrials.gov

Start Date

January 17, 2022

End Date

September 30, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Oystershell NV

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Gender: male / female.
•Women of childbearing potential is a premenopausal female that is anatomically and physiologically capable of becoming pregnant following menarche.
•Female subjects: are women of childbearing potential who test negative for pregnancy and agree to use a reliable method of birth control or remain abstinent during the study. Methods of contraception considered acceptable include oral contraceptives, contraceptive patch, intrauterine device, vaginal ring, diaphragm with contraceptive gel, or condom with contraceptive gel
•or are women of non-childbearing potential, defined as: women who have had surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation) or women who are ≥60 years of age.
•Age: ≥ 12 months of age year of age at the time of enrollment.
•Subject must have an active head lice infestation defined as at least 5 live lice (adults and/or nymphs) and 5 apparently live nits, present on the scalp and/or hair, as determined by a trained evaluator.
•Subject is in good general health based on medical history.
•The subject or his/her parent/legal guardian (from age 12-17), must give written informed consent, after having been oral and written informed about benefits and potential risks of the trial, as well as information regarding the insurance, taken out to cover the subjects participating in the study. A caregiver must sign an informed consent agreement for children not old enough to do so. Children ages 6-11 years of age will be administered a child's assent form. Subject or his/her parent/legal guardian must be capable of understanding and providing written informed consent.
•Following application and rinsing of the test products, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24-hour post treatment evaluation has been completed.
•The subject agrees not to cut or chemically treat their hair while participating in the study.

Exclusion Criteria

•Application of any form of head lice treatment, whether prescription or over-the-counter (OTC), or home remedy for 14 days prior to their screening visit (Visit 1).
•Application of any topical medication of any kind on the hair for a period of 48 hours prior to the screening visit.
•Use of systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results.
•Known skin allergies, multiple drug allergies or multiple allergies to cosmetic products.
•History of allergy or hypersensitivity to active ingredients, or constituents of the test products.
•Subject with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test product.
•Subjects with chronic scalp disorder.
•Subject or his/her legal guardian who, in the opinion of the investigative personnel, do not understand the subject requirements for study participations and/or may be likely to exhibit poor compliance with the required visits.
•Females who are pregnant or nursing.
•Hair longer than mid-back.

Arms & Interventions

Test product

Hemisqualane \& beeswax-based lotion (X92001752), killing lice and nits via suffocation.

Intervention: X92001752

RID Super Max Solution

Oligodecene oil-based lotion, killing lice and nits via suffocation.

Intervention: RID Super Max Solution

Nix Crème

Conventional pesticide, containing 1% permethrin.

Intervention: Nix Crème

Pouxit Végétal

Fatty acid salt-based lotion, killing lice and nits via suffocation.

Intervention: Pouxit Végétal

Outcomes

Primary Outcomes

Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Including All Baseline Infestations).

Time Frame: Day 10

Clinical efficacy is reflected by the % of subjects that are lice-free after 2 topical applications (at day 0 \& day 7 respectively) of the test product. In this analysis, all baseline infestations (mild, moderate, severe) have been included. Assessment is performed at study end (visit 4, day 10). A mild infestation corresponds to 5-9 lice and/or nymphs A moderate infestation corresponds to 10-24 lice and/or nymphs A severe infestation corresponds to 25 or more lice and/or nymphs

Secondary Outcomes

Number of Subjects That Are Lice-free After 2 Treatments With RID Super Max Solution (Including All Baseline Infestations).(Day 10)
Number of Subjects That Are Lice-free After 2 Treatments With Nix crème (Including All Baseline Infestations).(Day 10)
Number of Subjects That Are Lice-free After 1 Treatment With Pouxit Végétal (Including All Baseline Infestations).(Day 10)
Effect of All Investigational Treatments on Pruritus (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.(Day 0, Day 1, Day 7, Day 10)
Effect of All Investigational Treatments on Scalp Excoriation (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.(Day 0, Day 1, Day 7, Day 10)
Effect of All Investigational Treatments on Paraesthesia (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.(Day 0, Day 1, Day 7, Day 10)
Effect of All Investigational Treatments on Skin Erythema (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.(Day 0, Day 1, Day 7, Day 10)
Effect of All Investigational Treatments on Pyroderma (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.(Day 0, Day 1, Day 7, Day 10)
Global Tolerability, Evaluated at Study End (Visit 4, Day 10)(day 10)
Effect of All Investigational Treatments on Eye Irritation, as Assessed by a Blinded Clinical Investigator.(Day 0, Day 1, Day 7, Day 10)
Assessment of Adverse Events Occurring After 1 and/or 2 Treatments With Both Investigational Products.(Study period (10 days) + in case of adverse events: clinical staff will monitor the trial subject's safety from the occurrence of an AE until recovery, return to baseline or a stable state will be achieved.)