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NCT00301340 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:
An Open 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 NCT00301340
Other study ID # SU-03-2005
Secondary ID
Status Completed
Phase Phase 3
First received March 8, 2006
Last updated May 25, 2007
Start date March 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

Summers Laboratories has developed a non-pesticide treatment for head lice. Lice Asphyxiator (L.A.) works by mechanically blocking the respiratory spiracles of the head lice, therefore causing a quick-acting suffocation that will not result in the development of resistance.

The objectives of this open label study are to evaluate the efficacy and safety of home use of two 10-minute treatments of 5% L.A. (applied one week apart).

Recruitment information / eligibility
Status Completed
Enrollment 200
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, or treatment failure with any live lice from Protocol SU-01-2005 or Protocol SU-02-2005.

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, excluding protocols SU-01-2005 and SU-02-2005, within the past 30 days.

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• 5% Lice Asphyxiator lotion - Summers Laboratories, Inc.

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, 

See also
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Completed NCT00672971 - Safety and Efficacy Study to Compare a 4% Dimethicone Foam and Nix Cream Rinse (1% Permethrin) in the Control of Head Lice N/A
Completed NCT00858481 - A Pilot Dose Ranging Study of Spinosad Creme Rinse Phase 2
Completed NCT03301649 - Clinical Endpoint Study of Ivermectin 0.5% Lotion Phase 3
Completed NCT00994422 - Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects Phase 2
Completed NCT00995124 - Trial of the Ovicidal Activity of Three Head Lice Products (NeutraLice Lotion®, NeutraLice Advance® and Moov Head Lice Solution®) After a Single Application Phase 4
Completed NCT03337490 - A Clinical Endpoint Bioequivalence Study to Assess Efficacy and Safety of Ivermectin 0.5% Lotion in the Treatment of Head Lice Phase 3
Completed NCT06333054 - Safety and Efficacy of a Head Lice Shampoo N/A
Completed NCT02213055 - Pediatric Head Lice Study Product Comparison Phase 2
Completed NCT02974088 - Neem Lotion With Combing for Lice Phase 2
Recruiting NCT05379114 - Comparative Study for the Evaluation of a New Medical Device on the Treatment of Head Lice Infestation N/A
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 NCT01068158 - A Study Comparing the Safety and Efficacy of 0.5% Ivermectin Cream to Placebo in Lice Infested Subjects Phase 3
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 NCT00857935 - A Safety and Efficacy Pilot Study Comparing NatrOVA Creme Rinse 1% and NIX Creme Rinse Phase 2
Completed NCT02061813 - Dermal Safety Study to Evaluate Potential Irritation of Abametapir Lotion Phase 1
Completed NCT02062073 - Dermal Safety Study to Evaluate the Sensitizing Potential of Abametapir Lotion Phase 1
Completed NCT00605956 - NatrOVA Photoallergy Study - NatrOVA Creme Rinse in Healthy Volunteers Phase 1
Completed NCT00479310 - Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice Phase 3

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