IRCT2016071320514N5
Completed
Phase 3
Clinical trial to compare efficacy and safety of the Ivermectin 0.5% lotion and Permethrin 1% shampoo for treatment of pediculus humanus capitis infestation.
Gilaranco pharmaceutical and cosmecutical company0 sites176 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Pediculus Humanus Capitis infestation..
- Sponsor
- Gilaranco pharmaceutical and cosmecutical company
- Enrollment
- 176
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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