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

NCT00479310 | Completed Phase 3

• 1 other identifier: SU-02-2005
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

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

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 Design

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

Study Record Dates

• First Submitted: May 25, 2007
• First Posted: May 28, 2007
• Study Start: January 1, 2006
• Last Updated: May 28, 2007

Record last verified: 2007-05