Status:
COMPLETED
A Pilot Dose Ranging Study of Spinosad Creme Rinse
Lead Sponsor:
ParaPRO LLC
Conditions:
Pediculosis Capitis
Head Lice
Eligibility:
All Genders
2+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2005
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00858481
Start Date
September 1 2005
End Date
November 1 2005
Last Update
October 20 2015
Active Locations (1)
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1
Hill Top Research
West Palm Beach, Florida, United States, 33409