Clinical trial NCT03617926: A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product.
Official title: A Randomized, Controlled, Investigator-Assessor Blinded, Comparative Study to Evaluate the Safety and Efficacy of a Water-Soluble Head Lice Suffocation Product (X92001666) vs RID Shampoo (Pyrethrin) in Subjects With Head Lice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Lice
Pediculosis Capitis
Lead sponsor: Oystershell NV
Sponsor class: INDUSTRY
First posted: 2018-08-07
Enrollment: 70
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo).

Detailed description: The present study is set-up to compare in vivo clinical performance and safety of the test product versus an in the US commercially available, pyrethrum-based product (RID® shampoo). The study will be performed in subjects ≥2 year of both genders with confirmed diagnosis of head lice infestation. To support safety, local and global tolerability, skin and ocular irritation will be assessed and adverse events (AEs) will be registered.

Eligibility criteria: Inclusion Criteria:

1. Gender: male / female.
2. 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.
3. Age: ≥ 2 year of age at the time of enrollment.
4. 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.
5. Subject is in good general health based on medical history.
6. The subject or his/her parent/legal guardian 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 6-18 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.
7. 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.
8. The subject agrees not to cut or chemically treat their hair while participating in the study.
9. No more than one working male per household may be excluded from evaluation if he is assessed as being lice free by himself or caregiver.
10. Subject agrees to follow all study instructions, including attending all follow-up appointments.
11. Agree to not use any other pediculicides or medicated hair grooming products for the duration of the study (through Day 10 visit).
12. The parent or legal guardian of a child must be willing to have other family members screened for head lice. If other household members are found to have head lice and are eligible, they must be either enrolled in the study OR receive the standard of care at the site and in the same manner as study participants.
13. Have a single place of residence.
14. The subject or his/her parent or legal guardian must give written informed consent, after having been oral and written informed about benefits and potential risks of the trial, as well as details of the insurance taken out to cover the subjects participating in the study
15. Subjects must agree to not use any other ant-lice treatment for the duration of the study

Exclusion Criteria:

1. Application of any form of head lice treatment, whether prescription or over-the-counter (OTC), or home remedy for 30 days prior to their screening visit (Day 1).
2. Application of any topical medication of any kind on the hair for a period of 48 hours prior to the screening visit.
3. 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.
4. Known skin allergies, multiple drug allergies or multiple allergies to cosmetic products.
5. History of allergy or hypersensitivity to ragweed, active ingredients or constituents of the test products.
6. 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.
7. Subjects with chronic scalp disorder.
8. 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.
9. Females who are pregnant or nursing.
10. Hair longer than mid-back.
11. Subject suspected or known not to follow instructions
12. Previous participation in this study or participation in any other investigational trial within the preceding 30 days
13. The subject is directly affiliated to the investigator site personnel and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
14. The subject is an Oystershell employee or is an employee of a third-party organizations involved in the study.

Primary outcomes:
measure: Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Including All Baseline Infestations).
timeFrame: Day10
Secondary outcomes:
measure: Number of Subjects That Are Lice-free After 2 Treatments With Reference Product (Including All Baseline Infestations).
timeFrame: Day 10
measure: Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Only Mild and Moderate Baseline Infestations).
timeFrame: Day 10
measure: Number of Subjects That Are Lice-free After 2 Treatments With Reference Product (Only Mild and Moderate Baseline Infestations).
timeFrame: Day 10
measure: Number of Subjects That Are Lice-Free After 1 Treatment With Test Product (All Baseline Infestations).
timeFrame: Day 1
measure: Number of Subjects That Are Lice-free After 1 Treatment With Reference Product (All Baseline Infestations).
timeFrame: Day 1
measure: Effect of Both Investigational Treatments on Pruritus (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
timeFrame: Day 0, Day 1, Day 7, Day10
measure: Effect of Both Investigational Treatments on Scalp Excoriation (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
timeFrame: Day 0, Day 1, Day 7, Day10
measure: Effect of Both Investigational Treatments on Paraesthesia (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
timeFrame: Day 0, Day 1, Day 7, Day10
measure: Effect of Both Investigational Treatments on Skin Erythema (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
timeFrame: Day 0, Day 1, Day 7, Day10
measure: Effect of Both Investigational Treatments on Pyroderma (Local Tolerability Parameter), as Assessed by a Blinded Clinical Investigator.
timeFrame: Day 0, Day 1, Day 7, Day10
measure: Effect of Both Investigational Treatments on Eye Irritation, as Assessed by a Blinded Clinical Investigator.
timeFrame: Day 0, Day 1, Day 7, Day10
measure: Global Tolerability, Evaluated at Study End (Visit 4, Day 10)
timeFrame: Day 10
Other outcomes:
measure: Assessment of Adverse Events Occurring After 1 and 2 Treatments With Both Investigational Products.
timeFrame: 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.
Locations:
city: Miami
country: United States
facility: South Fla. Family Health & Research Ctr.LLC
state: Florida
city: Plantation
country: United States
facility: Lice Source Services, Inc.
state: Florida
Study officials:
affiliation: Study PI
name: Elisabeth Rivera, CPI
role: PRINCIPAL_INVESTIGATOR
References:
citation: Eertmans F, Rossel B, Serrano L, Rivera E, Adriaens E. Efficacy and Safety of a Water-Based Head Lice Lotion: A Randomized, Controlled, Investigator-Blinded, Comparative, Bicentric Study. Dermatol Ther (Heidelb). 2019 Mar;9(1):143-157. doi: 10.1007/s13555-018-0274-x. Epub 2018 Nov 30.