Head Lice, Pediculosis Capitis
Conditions
Keywords
Pediculosis capitis, Head Lice
Brief summary
A pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control.
Detailed description
A Phase 2a, randomized, single investigational site, investigator/evaluator-blind, four-arm, parallel-group, vehicle-controlled, pilot study to evaluate the safety and efficacy of different strengths of Spinosad Creme rinse verses vehicle control.
Interventions
DRUGSpinosad Creme Rinse - Vehicle Control
One or two, 10-minute topical applications (7 days apart)
0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
Sponsors
ParaPRO LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Active head lice infestation * Male or female, 2 years of age or older * Good general health * Appropriately signed Informed Consent * Subject agreement to not use any other form of lice treatment during the course of the study * Subject agreement to not cut or chemically treat their hair between visits
Exclusion criteria
* History of irritation or sensitivity to pediculicides or hair care products * Individuals with any visible skin/scalp condition that would interfere with the evaluation * Individuals previously treated with a pediculicide within 4 weeks prior to study enrollment * Individuals using hair dyes, bleaches, permanent waves or relaxing solutions 2 weeks prior to study enrollment * Individuals who have participated in any clinical trial within 30 days of enrollment * Individuals with family members who were infested with lice but were unwilling or unable to enroll in the study or use a standard course of lice treatment * Females who were pregnant or nursing * Sexually active females not using effective contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of various doses of Spinosad, based on the presence or absence of live lice at 7 and 14 days post-treatment. The efficacy evaluation was performed by a trained evaluator. | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation. | 14 days |
Countries
United States
Outcome results
None listed