Health Condition 1: B850- Pediculosis due to Pediculus humanus capitis
Conditions
Interventions
Intervention1: Spinosad 0.9% solution (Arm A): Intervention Description: Spinosad 0.9% Topical Solution is a prescription medication used for the treatment of head lice infestation. It contains Spinos
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must have an active head lice infestation of at least three live lice and/or viable nits. (Viability of nits to be determined by using magnifying lens at a distance of less than 0.6 cm from the scalp). Following application and rinsing of the test article, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24 hour post treatment evaluation has been completed. Subjects agree not to cut or chemically treat their hair while participating in the study. Subject and/or parent/guardian agree that the subject will not use any other form of lice treatment during the duration of the study. Subjects who are willing to sign informed consent for participation in the study. Subjects who are willing to sign informed assent for participation in the study.
Exclusion criteria
Exclusion criteria: Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study. Scalp condition that could make it difficult to evaluate the extent and severity of an infestation or that would present a problem in the evaluation of response to therapy (e.g. psoriatic scalp lesions, extensive seborrheic dermatitis). Treatment for head lice (OTC, home remedy and/or prescription drugs) in the last 7 days. Subject who used any hair dye, bleaches, hair straightening or permanent wave solution on the hair within 14 days of randomization. Known history of irritation or sensitivity to pediculicides or hair care products. Subjects with known allergy or hypersensitivity to Spinosad/Permethrin/Ivermectin or any component of the test product. Subjects who are a known case of epilepsy or any neurological disorder. Subject receiving any other treatment which may interfere with the study results. Participation in a previous investigational drug study within the past 30 days. Does not understand the requirements for study participation and/or may likely exhibit poor compliance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects within each treatment group who are lice free (without live lice) at the end of study.Timepoint: Subjects are assessed on day 1 (baseline) and on day 14 for the presence of live lice. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects within each treatment group who are free from viable nits at the end of study.Timepoint: Subjects are assessed on day 1 (baseline) and on day 14 for the presence of viable nits.;Proportion of subjects within each treatment group with improvement in Pruritus score at the end of study compared to baseline.Timepoint: Pruritis assessment scoring is done at the baseline (day 1) and at the end of the study (day 14) None =0 The scalp does not itch. Mild=1 Ocassional episodes of itching, not bothersome. Moderate=2 Frequent, several times a day, bothersome. Severe=3 Nearly constant, frequent scratching, very bothersome. | — |
Countries
India
Contacts
Public ContactDr Shashikumar BM
Mandya institute of medical sciences, Mandya
Outcome results
None listed