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A Pilot Dose Ranging Study of Spinosad Creme Rinse

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00858481
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : October 20, 2015
Sponsor:
Information provided by:
ParaPRO LLC

Study Description
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Brief Summary:
A pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control.

Condition or disease Intervention/treatment Phase
Pediculosis Capitis Head Lice Drug: Spinosad Creme Rinse - Vehicle Control Drug: Spinosad Creme Rinse Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Spinosad

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
Vehicle control
 Drug: Spinosad Creme Rinse - Vehicle Control
One or two, 10-minute topical applications (7 days apart)
Active Comparator: 2
0.5% Spinosad creme rinse
 Drug: Spinosad Creme Rinse
0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
Active Comparator: 3
1.0% Spinosad Creme Rinse
 Drug: Spinosad Creme Rinse
1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
Active Comparator: 4
2.0% Spinosad Creme Rinse
 Drug: Spinosad Creme Rinse
2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart)


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation. [ Time Frame: 14 days ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00858481


Locations
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United States, Florida
Hill Top Research
West Palm Beach, Florida, United States, 33409
Sponsors and Collaborators
ParaPRO LLC
Investigators
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Principal Investigator: Dyal Garg, Ph.D. Hill Top Research
More Information
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Responsible Party: Dyal Garg, Ph.D., Principal Investigator, Hill Top Research
ClinicalTrials.gov Identifier: NCT00858481    
Other Study ID Numbers: SPN-201-05
HTR-124235
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: October 20, 2015
Last Verified: October 2015
Keywords provided by ParaPRO LLC:
Pediculosis capitis
Head Lice
Additional relevant MeSH terms:
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Lice Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
 Infections
Skin Diseases, Infectious
Skin Diseases