Efficacy and Safety of Summers Non-Pesticide Lice Asphyxi... | NCT00479310

Studies
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice

NCT00479310

Sponsor

Summers Laboratories

Status

Completed

Last Update Posted

May 28, 2007Estimated

Enrollment

120

Phase

Phase 3

Conditions

Head Lice

Interventions

Summers 5% L.A.

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jan 2006

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 25, 2007

First Submission Date that Met QC Criteria

May 25, 2007

First Posted Date

May 28, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2007

Last Update Posted Date

May 28, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
Summers 5% L.A.	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment success is defined as the absence of live lice.

Secondary Outcomes

Measure	Description	Time Frame
The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20199404	Derived	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.