Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Summers Laboratories
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.

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Exclusion Criteria:

1. Participation in any clinical study within the past 30 days.

2. Known hypersensitivity to any ingredient in the product formulation.