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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Head Lice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Summers 5% L.A.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

References

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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.

Reference Type DERIVED

PMID: 20199404 (View on PubMed)

Other Identifiers

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SU-02-2005

Identifier Type: -

Identifier Source: org_study_id