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Trial record 50 of 106 for:    IVERMECTIN

A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice

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ClinicalTrials.gov Identifier: NCT03337490
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
bioRASI, LLC

Tracking Information
First Submitted Date  ICMJE October 30, 2017
First Posted Date  ICMJE November 9, 2017
Last Update Posted Date January 24, 2018
Actual Study Start Date  ICMJE October 2, 2017
Actual Primary Completion Date December 4, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
The proportion of index subjects who are lice free at Day 15 [ Time Frame: 15 Days ]
The primary endpoint is the proportion of index subjects who are lice free at Day 15
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03337490 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2017)
  • The number of all index subjects who are lice-free at Day 2 [ Time Frame: 2 Days ]
    The secondary endpoint includes the number of all index subjects who are lice-free at Day 2
  • The percentage of all index subjects who are lice-free at Day 2 [ Time Frame: 2 Days ]
    The secondary endpoint includes the percentage of all index subjects who are lice-free at Day 2
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 22, 2018)
  • Analysis of safety variables will be based on all adverse events (AE) [ Time Frame: Day 2, Day 8, Day 15 ]
    The safety analysis is the analysis of safety variables will be based on all adverse events (AE) capture measuring severity and duration
  • Analysis of tolerability will be based on scores of Stinging/Burning and Itching [ Time Frame: Day 2, Day 8, Day 15 ]
    The tolerability analysis is the analysis of tolerability will be based on scores of Stinging/Burning and Itching sensations collected during Subject Self-Assessment and Site Assessment at all followup visits between the test and reference treatment groups. For Itching: Score Grade Definition 0 None The scalp does not itch.
    1. Mild Occasional episodes of itching, not bothersome.
    2. Moderate Frequent, several times a day, bothersome.
    3. Severe Nearly constant, frequent, very bothersome.
    For Stinging/Burning: Score Grade Definition 0 None Absent
    1. Mild Slight, barely present
    2. Moderate Distinct presence
    3. Severe Marked, intense
Original Other Pre-specified Outcome Measures
 (submitted: November 6, 2017)
  • Analysis of safety variables will be based on all adverse events (AE) [ Time Frame: Day 2, Day 8, Day 15 ]
    The safety analysis is the analysis of safety variables will be based on all adverse events (AE) capture measuring severity and duration
  • Analysis of tolerability will be based on scores of Stinging/Burning and Itching [ Time Frame: Day 2, Day 8, Day 15 ]
    The tolerability analysis is the analysis of tolerability will be based on scores of Stinging/Burning and Itching sensations collected during Subject Self-Assessment and Site Assessment at all followup visits between the test and reference treatment groups.
 
Descriptive Information
Brief Title  ICMJE A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice
Official Title  ICMJE A Randomized, Multi-Center, Double-blind, Placebo Controlled, Parallel Group Trial to Evaluate Efficacy and Safety of Mayne Pharma's Ivermectin 0.5% Lotion Compared to Sklice® Ivermectin 0.5% Lotion in the Treatment of Head Lice
Brief Summary This is a phase 3 randomized, multi-center, double-blind, placebo controlled, parallel group design study.
Detailed Description This study is comprised of two phases: screening and treatment. The screening period is 24 hours, followed by the treatment phase of 15 ± 3 days. During the treatment phase, subjects will be randomized to either test, reference of placebo treatments (3:3:1) in a double-blind manner in an outpatient setting. Once eligibility is confirmed, randomization will occur at visit 2 (baseline, Day 1) i.e. initiation of treatment phase. The treatment phase will be 15 ± 3 days in duration wherein subject will receive treatment with investigational product (either test, reference or placebo) on Day 1 or baseline (visit 2). Efficacy will be evaluated at Day 15. Safety and tolerability will be evaluated based upon AEs and patient self-assessments and self-assessments collected during follow-up visits.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Head Lice
Intervention  ICMJE
  • Drug: Ivermectin 0.5% Topical Application Lotion
    Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.
  • Drug: Ivermectin 0.5% Topical Application Lotion [SKLICE]
    Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.
  • Drug: Placebo 0% Lotion
    Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.
Study Arms  ICMJE
  • Experimental: Ivermectin 0.5% Lotion
    Ivermectin 0.5% lotion, topical, 117g, single dose
    Intervention: Drug: Ivermectin 0.5% Topical Application Lotion
  • Active Comparator: Ivermectin 0.5% Lotion [SKLICE]
    Sklice 0.5% Lotion, topical, 117g, single dose
    Intervention: Drug: Ivermectin 0.5% Topical Application Lotion [SKLICE]
  • Placebo Comparator: Placebo 0% Lotion
    0% lotion, 117g, single dose
    Intervention: Drug: Placebo 0% Lotion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 22, 2018)
296
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2017)
280
Actual Study Completion Date  ICMJE December 18, 2017
Actual Primary Completion Date December 4, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects must have an active head lice infestation defined as: At least 3 live lice (adults and/or nymphs) present on the scalp and/or hair, as determined by a trained evaluator. The index subject must be the youngest family member, through the age of 18, presenting with an active head lice infestation.
  2. Household members that have an active head lice infestation defined as: At least 1 live louse (adult and/or nymph) present on the scalp and/or hair, as determined by a trained evaluator (with the exception of the male head of household who may self-assess as being lice free) will receive the Standard of Care with an over-the-counter head lice treatment product. Up to 3 infested household members may receive treatment, if more than 3 household members are infested, the entire household will be excluded from the study.
  3. Subject is male or female.
  4. Index subject is at least 6 months through 18 years of age at time of enrollment.
  5. Subject is in good general health based on medical history.
  6. 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 ages 6-17 years of age will be administered a child's Assent Form.
  7. 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 the Standard of Care. No more than one working male per household may be excluded from evaluation if he is assessed as being lice free by himself or the caregiver and cannot come in due to his work schedule. If this individual may have lice, he must come to the test facility; otherwise the entire household will be excluded from study participation.
  8. Subject and/or their caregiver must be physically able and willing to apply the test product according to established treatment methods.
  9. Subject agrees not to use any other form of lice treatments (commercial, community-anecdotal, or mechanical/manual) while participating in the study.
  10. Following application and rinsing of the test product, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24-hour post-treatment evaluation has been completed.
  11. Subject agrees to not cut or chemically treat their hair while participating in the study.
  12. Subject agrees to follow all study instructions, including attending all follow-up appointments.
  13. Female index subjects of childbearing potential must be willing to have a urine pregnancy test prior to inclusion in this study.
  14. In the event of a subject judged to be incapable of self-treating, the household must have a caregiver willing to apply the treatment at home.

Exclusion Criteria:

  1. Index subjects with greater than 3 household members with at least 1 live louse (adult and/or nymph) present on the scalp and/or hair, as determined by a trained evaluator will be automatically excluded from the trial.
  2. Youngest household member is over 18 years of age.
  3. History of irritation or sensitivity to ivermectin or the lotion components, pediculicides or hair care products.
  4. Presentation at the treatment site with visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score that is >2, blisters, vesicles which, in the opinion of the investigative personnel or medical monitor, will interfere with safety and/or efficacy evaluations.
  5. Presentation at the treatment site with eczema or atopic dermatitis.
  6. Treatment for head lice (Over the counter [OTC], home remedy and/or Prescription) in the last 15 days.
  7. Any condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol.
  8. Is receiving any other treatment which, in the opinion of the investigator or medical monitor, may interfere with the study results.
  9. Females (including caregivers who come in contact with the investigational product) who are pregnant, nursing or planning a pregnancy which could include index subjects. If a household has a pregnant female who has an active case of lice, the entire household is excluded from participation. If this pregnant household member does not have an active infestation, this individual must NOT be the caregiver (one who provides treatment to other household members).
  10. Index subject of child-bearing potential, and unwilling to use an adequate method of contraception for the duration of the study. Adequate methods of contraception include: abstinence, vasectomized 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 sterilization. Index subjects and/or their 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 sterilization.
  11. Participation in a previous investigational drug study within the past 30 days.
  12. Does not understand the requirements for study participation and/or may likely exhibit poor compliance, in the opinion of the investigator.
  13. 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 or apartment unit).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03337490
Other Study ID Numbers  ICMJE MAP-7189
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party bioRASI, LLC
Study Sponsor  ICMJE bioRASI, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account bioRASI, LLC
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP