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

NCT00301327 | Completed Phase 3

• 1 other identifier: SU-01-2005
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Head Lice

Outcome Measures

Primary Outcomes (1)

• Treatment success is defined as the absence of live lice.

Secondary Outcomes (1)

• The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.

Interventions

Summers 5% L.A. DRUG

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Summers Laboratories: lead

Study Sites (5)

Global Health Associates of Miami 7800, SW 57 Avenue, Suite 219E

Miami, Florida, 33143, United States

Location

Alegent Health, Harmony Street, 2nd Floor

Council Bluffs, Iowa, 51503-3147, United States

Location

Dermatology Research Associates 7691 Five Mile Road, Suite 312

Cincinnati, Ohio, 45230, United States

Location

Diagnostic Clinic of Longview, TX 707 Hollybrook Drive

Longview, Texas, 75605, United States

Location

Wee Care Pediatrics, 1580 West Antelope Drive, Suite 100

Layton, Utah, 84041, United States

Location

Related Publications (1)

• 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.

  PMID: 20199404 DERIVED

Related Links

• Related Info

Study Officials

• Terri Meinking

  Global Health Associates of Miami

  PRINCIPAL INVESTIGATOR

• Anne Lucky, Dr.

  Dermatology Research Associates

  PRINCIPAL INVESTIGATOR

• Jon Thomas, Dr.

  Alegent Health

  PRINCIPAL INVESTIGATOR

• E.A. Clark, Dr.

  Diagnostic Clinic of Longview, TX

  PRINCIPAL INVESTIGATOR

• Peter E Silas, Dr.

  Advanced Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 8, 2006
• First Posted: March 10, 2006
• Study Start: January 1, 2006
• Last Updated: May 30, 2007

Record last verified: 2007-05

Locations

US (5)