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

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ClinicalTrials.gov Identifier: NCT03617926
Recruitment Status : Completed
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Oystershell NV

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).

Condition or disease Intervention/treatment Phase
Head Lice Pediculosis Capitis Device: X92001666 Other: RID shampoo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 7, 2018
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Test product
Water-based lotion (internal code (X92001666)
Device: X92001666
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.
Other Name: Test product

Active Comparator: Reference
Commercial, pyrethrin-based shampoo (RID shampoo)
Other: RID shampoo
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.
Other Name: Reference




Primary Outcome Measures :
  1. Efficacy and safety of the test product at study end. (cure rate) [ Time Frame: Day10 ]
    Following topical application, for all baseline infestations, the cure rate (corrected for re-infestation) of the test product is superior to a predefined limit of 70% at study end. Also, efficacy and safety of the test product is compared against reference product.


Secondary Outcome Measures :
  1. Efficacy of the reference product product at study end. (cure rate) [ Time Frame: Day 10 ]
    Following topical application, for all baseline infestations, the cure rate (corrected for re-infestation) with the reference product is better than 70% at study end.

  2. Superiority or non-inferiority of the test product versus the reference product at study end. (cure rate) [ Time Frame: Day10 ]
    The test product has a cure rate superior to that of the reference product at study end. In case that superiority cannot be shown: the test product is non-inferior to the reference product, using a non-inferiority margin of 7.5%.

  3. Efficacy of test product and reference against mild and moderate baseline infestations at study end. (cure rate) [ Time Frame: Day 10 ]
    Efficacy of the investigational products against mild (5-9 lice and/or nymphs) and moderate (10-24 lice and/or nymphs) baseline infestations, as reflected by the cure rate (corrected for re-infestation) at study end.

  4. Efficacy of test product and reference following one treatment - all baseline infestations (cure rate) [ Time Frame: Day 1 ]
    Efficacy of the investigational products for all baseline infestations following the first treatment, as reflected by the cure rate at day 1.

  5. Efficacy of test product and reference following one treatment - mild and moderate baseline infestations (cure rate) [ Time Frame: Day 1 ]
    Efficacy of the investigational products for mild (5-9 lice and/or nymphs) and moderate (10-24 lice and/or nymphs) infestations following the first treatment, as reflected by the cure rate at day 1.

  6. Safety of the investigational products - Local tolerability [ Time Frame: Day 0, Day 1, Day 7, Day10 ]
    Local tolerability: subjective symptoms (burning, paraesthesia, pruritus) are rated using the following scores: none, mild, moderate, and severe.

  7. Safety of the investigational products - Global tolerability [ Time Frame: Day 10 ]
    Global tolerability: rated using the following scores: very good, good, moderate, or poor.

  8. Safety of the investigational products - Skin irritation [ Time Frame: Day 0, Day 1, Day 7, Day10 ]
    Skin irritation: presence of secondary infection, erythema, excoriation. Rated using the following scores: none, mild, moderate or severe.

  9. Safety of the investigational products - Eye irritation [ Time Frame: Day 0, Day 1, Day 7, Day10 ]
    Presence of eye irritation (redness, tingling...) by study staff, using the following scores: none, mild, moderate, or severe.


Other Outcome Measures:
  1. Safety of the investigational products - Adverse events [ Time Frame: Day0, Day 1, Day 7, Day10 ]
    Recording Adverse Events and investigating the relationship with the treatment.



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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03617926


Locations
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United States, Florida
South Fla. Family Health & Research Ctr.LLC
Miami, Florida, United States, 33186
Lice Source Services, Inc.
Plantation, Florida, United States, 33313
Sponsors and Collaborators
Oystershell NV
Investigators
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Principal Investigator: Elisabeth Rivera, CPI Study PI

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oystershell NV
ClinicalTrials.gov Identifier: NCT03617926     History of Changes
Other Study ID Numbers: OYS007-0017
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
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Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases