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Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation

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ClinicalTrials.gov Identifier: NCT00857948
Recruitment Status : Completed
First Posted : March 9, 2009
Results First Posted : March 30, 2012
Last Update Posted : March 30, 2012
Sponsor:
Information provided by (Responsible Party):
Topaz Pharmaceuticals Inc

Tracking Information
First Submitted Date  ICMJE March 6, 2009
First Posted Date  ICMJE March 9, 2009
Results First Submitted Date  ICMJE March 1, 2012
Results First Posted Date  ICMJE March 30, 2012
Last Update Posted Date March 30, 2012
Study Start Date  ICMJE March 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2012)
Percentage of Participants Who Were Lice-Free by Day 2 That Were Maintained Through Day 15 Post-treatment With Either Ivermectin or Placebo (Vehicle Control) [ Time Frame: Day 1 through Day 15 post-application ]
Live lice eradication was assessed by visual checks of hair and scalp on Days 1, 2 and 8 and by visual checks and counting both live and dead lice from rinse water on Day 15. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.
Original Primary Outcome Measures  ICMJE
 (submitted: March 6, 2009)
Presence or absence of live lice after final study drug application [ Time Frame: 14 Days ]
Change History Complete list of historical versions of study NCT00857948 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2012)
  • Percentage of Index Participants Who Were Lice-Free at Different Time Points Post-treatment With Either Ivermectin or Placebo (Vehicle Control) [ Time Frame: Day 1 through Day 8 post-application ]
    Live lice eradication was assessed on Days 1, 2, and 8 by visual checks of hair and scalp. Eradication was defined as cessation of motility (antennae and leg movement) in all lice.
  • Level of Live Lice Infestation at Different Time Points Post-Treatment With Either Ivermectin or Placebo (Vehicle Control) [ Time Frame: Day 1 through Day 15 post-application ]
    The severity of lice infestation was determined by visual checks of hair and scalp. Severity was rated as None: no live lice; Mild: 1 to 5 live lice; Moderate: 6 to 10 live lice; Severe: 11 to 20 live lice; or Very severe > 20 live lice.
  • Number of Participants Reporting Treatment-Emergent Adverse Events Post-treatment With Either Ivermectin or Placebo (Vehicle Control). [ Time Frame: Day 1 up to Day 28 post-application ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2009)
Evaluation of safety based on reported adverse events. [ Time Frame: Throughout study duration ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation
Official Title  ICMJE A Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of 3 Strengths of Ivermectin Treatment Conditioner and Placebo in Subjects With Pediculus Humanus Capitis (Head Lice) Infestation
Brief Summary This is a Phase 2 single center study designed to compare the safety, local tolerability, and efficacy of 3 strengths of ivermectin treatment conditioner to placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pediculus Humanus Capitis (Head Lice)
Intervention  ICMJE
  • Drug: ivermectin treatment conditioner
    Application followed by thorough rinsing of the hair and scalp with water.
  • Drug: Placebo, vehicle control
    Application followed by thorough rinsing of the hair and scalp with water.
Study Arms  ICMJE
  • Experimental: 0.15% ivermectin
    Participant on 0.15% ivermectin treatment conditioner
    Intervention: Drug: ivermectin treatment conditioner
  • Experimental: 0.25% ivermectin
    Participants on 0.25% ivermectin treatment conditioner
    Intervention: Drug: ivermectin treatment conditioner
  • Experimental: 0.50% ivermectin
    Participants on 0.50% ivermectin treatment conditioner
    Intervention: Drug: ivermectin treatment conditioner
  • Placebo Comparator: Placebo
    participants on Placebo (Vehicle control)
    Intervention: Drug: Placebo, vehicle control
Publications * Meinking TL, Mertz-Rivera K, Villar ME, Bell M. Assessment of the safety and efficacy of three concentrations of topical ivermectin lotion as a treatment for head lice infestation. Int J Dermatol. 2013 Jan;52(1):106-12. doi: 10.1111/j.1365-4632.2012.05629.x.

*   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: September 22, 2010)
78
Original Estimated Enrollment  ICMJE
 (submitted: March 6, 2009)
72
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who are at least 6 months old and weighing at least 15 kg.
  • Infestation with head lice and viable nits.
  • Are otherwise in a normal state of health.
  • Willing and able to attend all study visits as scheduled.
  • Agree not to cut or chemically treat their hair in the period between treatment and the final visit.
  • The subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent.
  • Females of childbearing potential must have a negative urine pregnancy test at screening and agree to take reasonable precautions against becoming pregnant during the study period.

Exclusion Criteria:

  • Subjects who have received any over the counter or prescription treatment for head lice in the last 2 weeks.
  • Subjects unable to comply with the study obligations and all study visits.
  • Subjects with eczema or other chronic conditions of the scalp and skin.
  • Subjects in a household with more than 5 infested members.
  • Subjects with a history of allergy to ivermectin or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.
  • Subjects with neurologic conditions including a seizure disorder or history of seizures.
  • Subjects with an infestation of body lice or pubic lice (determined by questioning).
  • Subjects suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment, which in the opinion of the Investigator and visiting physician could influence the results of the study.
  • Subjects with other diagnoses which, in the opinion of the Investigator, would interfere with efficacy or safety assessments or would preclude study participation.
  • Subjects with very short (shaved) hair.
  • Subjects who have been treated with a systemic antibiotic within the previous 2 weeks before screening.
  • Subjects who have been previously enrolled in any clinical study within the past 30 days; subjects may not participate in another study while participating in this study.
  • Pregnant and/or nursing females.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months and older   (Child, Adult, Older 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 NCT00857948
Other Study ID Numbers  ICMJE TOP003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Topaz Pharmaceuticals Inc
Study Sponsor  ICMJE Topaz Pharmaceuticals Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Topaz
PRS Account Topaz Pharmaceuticals Inc
Verification Date March 2012

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