Back to resultsA Pilot Dose Ranging Study of Spinosad Creme Rinse
Primary Purpose
Pediculosis Capitis, Head Lice
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Spinosad Creme Rinse - Vehicle Control
Spinosad Creme Rinse
Spinosad Creme Rinse
Spinosad Creme Rinse
Sponsored by
About this trial
This is an interventional treatment trial for Pediculosis Capitis focused on measuring Pediculosis capitis, Head Lice
Eligibility Criteria
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
Sites / Locations
- Hill Top Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
Vehicle control
0.5% Spinosad creme rinse
1.0% Spinosad Creme Rinse
2.0% Spinosad Creme Rinse
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00858481
Brief Title
A Pilot Dose Ranging Study of Spinosad Creme Rinse
Official Title
Efficacy and Safety of Different Strengths of Spinosad Topical Creme (0%, 0.5%, 1.0% or 2%) in Subjects With Pediculosis Capitis - a Dose Ranging Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
ParaPRO LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediculosis Capitis, Head Lice
Keywords
Pediculosis capitis, Head Lice
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Vehicle control
Arm Title
2
Arm Type
Active Comparator
Arm Description
0.5% Spinosad creme rinse
Arm Title
3
Arm Type
Active Comparator
Arm Description
1.0% Spinosad Creme Rinse
Arm Title
4
Arm Type
Active Comparator
Arm Description
2.0% Spinosad Creme Rinse
Intervention Type
Drug
Intervention Name(s)
Spinosad Creme Rinse - Vehicle Control
Intervention Description
One or two, 10-minute topical applications (7 days apart)
Intervention Type
Drug
Intervention Name(s)
Spinosad Creme Rinse
Intervention Description
0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
Intervention Type
Drug
Intervention Name(s)
Spinosad Creme Rinse
Intervention Description
1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
Intervention Type
Drug
Intervention Name(s)
Spinosad Creme Rinse
Intervention Description
2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart)
Primary Outcome Measure Information:
Title
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dyal Garg, Ph.D.
Organizational Affiliation
Hill Top Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hill Top Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
12. IPD Sharing Statement
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A Pilot Dose Ranging Study of Spinosad Creme Rinse
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