Efficacy and safety assessment of the topical Ivermectin 0.5% in pediculus capitis infestation.
- Conditions
- Pediculus Humanus Capitis infestation..Pediculosis due to Pediculus humanus capitis
- Registration Number
- IRCT2016071320514N5
- Lead Sponsor
- Gilaranco pharmaceutical and cosmecutical company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 176
at least 6 months of age; presence of at least 3 live lice or 10 viable eggs (eggs found within 1.27 cm of the scalp); participants with good general health; signing the written informed consent by the capable participants or by their legal guardians for incapable ones; agree not to use any other forms of lice treatments except the test items; agrees not to cut their hair while participating in the study.
history of irritation or sensitivity to Ivermectin or its components or other pediculicides products; presence of visible skin/scalp condition(s) that are not attributable to head lice infestation, such as an erythema score >2, blisters or vesicles at the treatment site ; presence of eczema or atopic dermatitis at the treatment site; history of treatment for head lice include OTC, home remedy or Rxin during the last 7 days; any condition or illness that, in investigator’s opinion, may compromise the objective of the protocol; pregnancy, lactation or planning to become pregnant during the study; participation in a previous investigational drug study within the past 30 days; prior participation in any Ivermectin trials
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients in both groups with no live lice or viable eggs (eggs found on hair within 1.27 cm of the scalp) on the scalp examination. Timepoint: Before treatment and 1, 7 and 14 day after treatment. Method of measurement: Physical exam by a trained evaluator.
- Secondary Outcome Measures
Name Time Method Observed skin/scalp reactions and periocular skin irritation. Timepoint: Before treatment and 1, 7 and 14 day after treatment. Method of measurement: Physical exam by a trained evaluator.