Pediculus Humanus Capitis infestation.. Pediculosis due to Pediculus humanus capitis
Conditions
Interventions
Intervention 1: Intervention group: topical Ivermectin lotion, product from Gilaranco company contains Ivermectin 0.5%, once.
The whole bottle of the lotion should directly applied on dry hair and
Treatment - Drugs
Intervention group: topical Ivermectin lotion, product from Gilaranco company contains Ivermectin 0.5%, once.
The whole bottle of the lotion should directly applied on dry hair and scalp and stay
Control group: Topical Permethrin shampoo, product from Gilaranco company contains 1% Permethrin, twice with one week interval.
the whole bottle of the product should be apply on the wet hair and s
Sponsors
Gilaranco pharmaceutical and cosmecutical company
Eligibility
Sex/Gender
All
Age
6 Months to No maximum
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAlireza Firooz
Center for Research & Training in Skin Diseases & Leprosy
Outcome results
None listed