Back to resultsEfficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice
Primary Purpose
Head Lice
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Summers 5% L.A.
Sponsored by
About this trial
This is an interventional treatment trial for Head Lice
Eligibility Criteria
Inclusion Criteria:
- Males and females 6 months of age or older.
- Have an active infestation with Pediculus capitis, the human head louse, with at least three live lice at baseline.
- Agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study.
- Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period.
- Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form.
- Subject or guardian has read, understood, and signed appropriate informed consent in English. If English is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language.
- Subject is willing to participate in the study, and abide by the protocol requirements.
Exclusion Criteria:
- Participation in any clinical study within the past 30 days.
- Known hypersensitivity to any ingredient in the product formulation.
Sites / Locations
Outcomes
Primary Outcome Measures
Treatment success is defined as the absence of live lice.
Secondary Outcome Measures
The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00479310
Brief Title
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice
Official Title
A Multi-Center, Randomized, Vehicle Controlled, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the Treatment of Head Lice.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Summers Laboratories
4. Oversight
5. Study Description
Brief Summary
A Multi-center, Randomized, Vehicle Controlled, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the treatment of Head Lice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Lice
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Summers 5% L.A.
Primary Outcome Measure Information:
Title
Treatment success is defined as the absence of live lice.
Secondary Outcome Measure Information:
Title
The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Males and females 6 months of age or older.
Have an active infestation with Pediculus capitis, the human head louse, with at least three live lice at baseline.
Agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study.
Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period.
Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form.
Subject or guardian has read, understood, and signed appropriate informed consent in English. If English is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language.
Subject is willing to participate in the study, and abide by the protocol requirements.
Exclusion Criteria:
Participation in any clinical study within the past 30 days.
Known hypersensitivity to any ingredient in the product formulation.
12. IPD Sharing Statement
Citations:
PubMed Identifier
20199404
Citation
Meinking TL, Villar ME, Vicaria M, Eyerdam DH, Paquet D, Mertz-Rivera K, Rivera HF, Hiriart J, Reyna S. The clinical trials supporting benzyl alcohol lotion 5% (Ulesfia): a safe and effective topical treatment for head lice (pediculosis humanus capitis). Pediatr Dermatol. 2010 Jan-Feb;27(1):19-24. doi: 10.1111/j.1525-1470.2009.01059.x.
Results Reference
derived
Links:
URL
http://www.sumlab.com
Description
Related Info
Learn more about this trial
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice
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