A Pilot Dose Ranging Study of Spinosad Creme Rinse (NCT00858481) | Clinical Trial Compass
CompletedPhase 2
A Pilot Dose Ranging Study of Spinosad Creme Rinse
United States36 participantsStarted 2005-09
Plain-language summary
A pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control.
Who can participate
Age range2 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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.