Clinical trial NCT00301327: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head Lice
Lead sponsor: Summers Laboratories
Sponsor class: INDUSTRY
First posted: 2006-03-10
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double blind, vehicle controlled, study designed to evaluate the pediculicidal activity of Summers 5% L.A. compared to a vehicle control.


Eligibility criteria: Inclusion Criteria:

1. Males and females 6 months of age or older.
2. Have an active infestation with pediculus capitis, the human head louse, with at least three live lice at baseline.
3. Agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study.
4. Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period.
5. Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form.
6. 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.
7. Subject is willing to participate in the study, and abide by the protocol requirements.

   -

Exclusion Criteria:

1. Participation in any clinical study within the past 30 days.
2. Known hypersensitivity to any ingredient in the product formulation.

Primary outcomes:
measure: Treatment success is defined as the absence of live lice.
Secondary outcomes:
measure: The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.
Other outcomes:
Locations:
city: Miami
country: United States
facility: Global Health Associates of Miami 7800, SW 57 Avenue, Suite 219E
state: Florida
city: Council Bluffs
country: United States
facility: Alegent Health, Harmony Street, 2nd Floor
state: Iowa
city: Cincinnati
country: United States
facility: Dermatology Research Associates 7691 Five Mile Road, Suite 312
state: Ohio
city: Longview
country: United States
facility: Diagnostic Clinic of Longview, TX 707 Hollybrook Drive
state: Texas
city: Layton
country: United States
facility: Wee Care Pediatrics, 1580 West Antelope Drive, Suite 100
state: Utah
Study officials:
affiliation: Global Health Associates of Miami
name: Terri Meinking
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Research Associates
name: Anne Lucky, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Alegent Health
name: Jon Thomas, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Diagnostic Clinic of Longview, TX
name: E.A. Clark, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced Clinical Research Institute
name: Peter E Silas, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.