A Phase 1 interventional study of Ivermectin Lotion, 0.5% and SKLICE (ivermectin) Lotion, 0.5% in Lice; Head Lice, sponsored by Taro Pharmaceuticals USA. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-18.
Sponsored by Taro Pharmaceuticals USA (part of Sun Pharmaceutical Industries Limited) · Phase 1, Interventional, and Treatment
A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5%
A Multi-Center, Double-Blind, Randomized, Placebo controlled, Parallel-group study, comparing Ivermectin Lotion, 0.5% to Sklice (Ivermectin) Lotion, 0.5% and both active treatment to a placebo control in the treatment of subjects with active infestation with head lice and their Ova
43 studies on the registry are indexed under Lice Infestations; 4 are open to participants now.
This study's enrollment of 413 is above the median of 105 across 42 interventional studies indexed under Lice Infestations.
Browse Lice Infestations studies →Taro Pharmaceuticals USA is the lead sponsor of 71 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.
First submitted after Taro Pharmaceuticals USA became part of Sun Pharmaceutical Industries Limited.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
One 10 minute application, under at-home use conditions
Drug: Ivermectin Lotion, 0.5%
One 10 minute application, under at-home use conditions
Drug: SKLICE (ivermectin) Lotion, 0.5%
One 10 minute application, under at-home use conditions
Drug: Vehicle of the Test product
Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
Also known as: ivermectin
SKLICE (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC)
Also known as: ivermectin
Vehicle for Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
Also known as: placebo
Demonstration of Bioequivalence in proportion of index subjects who are lice free
Demonstration of Bioequivalence in proportion of index subjects who are lice free
Time frame: Day 15 (14 days after application of study treatment)
Plan to share: No
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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ivermectin