- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00857948
Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation
March 1, 2012 updated by: Topaz Pharmaceuticals Inc
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
78
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33143
- Global Health Associates of Miami
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 0.15% ivermectin
Participant on 0.15% ivermectin treatment conditioner
|
Application followed by thorough rinsing of the hair and scalp with water.
|
EXPERIMENTAL: 0.25% ivermectin
Participants on 0.25% ivermectin treatment conditioner
|
Application followed by thorough rinsing of the hair and scalp with water.
|
EXPERIMENTAL: 0.50% ivermectin
Participants on 0.50% ivermectin treatment conditioner
|
Application followed by thorough rinsing of the hair and scalp with water.
|
PLACEBO_COMPARATOR: Placebo
participants on Placebo (Vehicle control)
|
Application followed by thorough rinsing of the hair and scalp with water.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1 through Day 15 post-application
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Day 1 through Day 8 post-application
|
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.
|
Day 1 through Day 15 post-application
|
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
|
Day 1 up to Day 28 post-application
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (ACTUAL)
April 1, 2009
Study Completion (ACTUAL)
April 1, 2009
Study Registration Dates
First Submitted
March 6, 2009
First Submitted That Met QC Criteria
March 6, 2009
First Posted (ESTIMATE)
March 9, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
March 30, 2012
Last Update Submitted That Met QC Criteria
March 1, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TOP003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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