A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product.

NCT03617926 | Completed Results FDA Device

• 1 other identifier: OYS007-0017
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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).

Conditions

Head Lice; Pediculosis Capitis

Outcome Measures

Primary Outcomes (1)

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

  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

  Day10

Secondary Outcomes (12)

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

  Day 10

• Number of Subjects That Are Lice-free After 2 Treatments With Test Product (Only Mild and Moderate Baseline Infestations).

  Day 10

• Number of Subjects That Are Lice-free After 2 Treatments With Reference Product (Only Mild and Moderate Baseline Infestations).

  Day 10

• Number of Subjects That Are Lice-Free After 1 Treatment With Test Product (All Baseline Infestations).

  Day 1

• Number of Subjects That Are Lice-free After 1 Treatment With Reference Product (All Baseline Infestations).

  Day 1

Other Outcomes (1)

• Assessment of Adverse Events Occurring After 1 and 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.

Study Arms (2)

Test product

EXPERIMENTAL

Water-based lotion (internal code (X92001666)

Device: X92001666

Reference

ACTIVE COMPARATOR

Commercial, pyrethrin-based shampoo (RID shampoo)

Other: RID shampoo

Interventions

X92001666 DEVICE

the X92001666 product is a lotion to be applied on dry hair for 15 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.

Also known as: Test product

Test product

RID shampoo OTHER

Active Comparator: RID shampoo The RID shampoo is to be applied on dry the hair for 10 minutes and then rinsed out with water. the product is to be applied on Day 0 and repeated again on Day 7.

Also known as: Reference

Reference

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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: ≥ 2 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 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.
• 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.
• 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.
• Subject agrees to follow all study instructions, including attending all follow-up appointments.
• Agree to not use any other pediculicides or medicated hair grooming products for the duration of the study (through Day 10 visit).
• 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.

You may not qualify if:

• 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).
• 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 ragweed, 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.
• Subject suspected or known not to follow instructions
• Previous participation in this study or participation in any other investigational trial within the preceding 30 days
• 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
• The subject is an Oystershell employee or is an employee of a third-party organizations involved in the study.

Sponsors & Collaborators

• Oystershell NV: lead

Study Sites (2)

South Fla. Family Health & Research Ctr.LLC

Miami, Florida, 33186, United States

Location

Lice Source Services, Inc.

Plantation, Florida, 33313, United States

Location

Related Publications (1)

• 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.

  PMID: 30506361 DERIVED

Limitations and Caveats

Limitations of this study: 1. Moderate number of subjects. 2. Reference product: instead of a pyrethroid-based product, a silicone-based pediculicide might have served as reference. 3. No subgroup analyses performed to evaluate the impact of infestation degree, hair characteristics, \& other parameters. However, no remarkable differences found in baseline parameters between both groups. 4. Dry combing to diagnose a head lice infestation (may be less sensitive compared to wet combing).

Results Point of Contact

• Title: Frank Eertmans
• Organization: Oystershell Laboratories

fe@oystershell.be

+3293772485

Study Officials

• Elisabeth Rivera, CPI

  Study PI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: August 7, 2018
• Study Start: March 7, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: July 5, 2022
• Results First Posted: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)