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NCT00301327 Clinical Trial

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

Head Lice Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00301327
Other study ID # SU-01-2005
Secondary ID
Status Completed
Phase Phase 3
First received March 8, 2006
Last updated May 25, 2007
Start date January 2006

Study information
Verified date May 2007
Source Summers Laboratories
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 6 Months and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Summers 5% L.A.

Locations
Country Name City State
United States Dermatology Research Associates 7691 Five Mile Road, Suite 312 Cincinnati Ohio
United States Alegent Health, Harmony Street, 2nd Floor Council Bluffs Iowa
United States Wee Care Pediatrics, 1580 West Antelope Drive, Suite 100 Layton Utah
United States Diagnostic Clinic of Longview, TX 707 Hollybrook Drive Longview Texas
United States Global Health Associates of Miami 7800, SW 57 Avenue, Suite 219E Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
Summers Laboratories

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment success is defined as the absence of live lice.
Secondary The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.
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