Dose Ranging Study of Ivermectin Treatment Conditioner in Subjects With Head Lice Infestation
NCT ID: NCT00857948
Last Updated: 2012-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2009-03-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0.15% ivermectin
Participant on 0.15% ivermectin treatment conditioner
ivermectin treatment conditioner
Application followed by thorough rinsing of the hair and scalp with water.
0.25% ivermectin
Participants on 0.25% ivermectin treatment conditioner
ivermectin treatment conditioner
Application followed by thorough rinsing of the hair and scalp with water.
0.50% ivermectin
Participants on 0.50% ivermectin treatment conditioner
ivermectin treatment conditioner
Application followed by thorough rinsing of the hair and scalp with water.
Placebo
participants on Placebo (Vehicle control)
Placebo, vehicle control
Application followed by thorough rinsing of the hair and scalp with water.
Interventions
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ivermectin treatment conditioner
Application followed by thorough rinsing of the hair and scalp with water.
Placebo, vehicle control
Application followed by thorough rinsing of the hair and scalp with water.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
6 Months
ALL
No
Sponsors
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Topaz Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Topaz
Locations
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Global Health Associates of Miami
Miami, Florida, United States
Countries
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References
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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.
Other Identifiers
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TOP003
Identifier Type: -
Identifier Source: org_study_id