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NCT00479310 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 NCT00479310
Other study ID # SU-02-2005
Secondary ID
Status Completed
Phase Phase 3
First received May 25, 2007
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

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.

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, 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
n/a

Sponsors (1)
Lead Sponsor Collaborator
Summers Laboratories

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.
See also
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Completed NCT03617926 - A Clinical Trial to Evaluate Efficacy and Safety of a Water-soluble Head Lice Product. N/A
Completed NCT01803581 - A Study to Evaluate the Safety and Efficacy of Product X92001327 vs RID Shampoo in Subjects With Head Lice N/A
Completed NCT01066585 - A Safety and Efficacy Study Comparing 0.5% Ivermectin Cream to a Vehicle Control in Subjects With Head Lice Infestation Phase 3
Completed NCT01068158 - A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects Phase 3
Completed NCT00857935 - A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse Phase 2
Completed NCT00301340 - Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice Phase 3
Completed NCT02061813 - Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion Phase 1
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