A Dose Ranging Study of Different Strengths of Spinosad Topical Creme in Subjects With Pediculosis Capitis

Study Description

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Brief Summary:

The primary objective of the study is to determine the safety and efficacy of different strengths of Spinosad topical creme, as compared to a vehicle control, in subjects who have been infested with at least a mild case of Pediculosis capitis (head lice).

Condition or disease	Intervention/treatment	Phase
Pediculosis Capitis (Head Lice)	Drug: Spinosad Creme Rinse	Phase 2

Detailed Description:

There are millions of children and adults affected with head lice each year in the United States. It has become a major nuisance in school children resulting in many lost school days and frustrated parents. Lice and nit (ova) resistance to current OTC products has been reported. Compliance with product instructions is thought to be low. Therefore a safe and effective alternative to these products is desirable.

Spinosad and its formulations have been approved by the Environmental Protection Agency as crop protection products in the US, Canada and Australia, and has received provisional approval in the UK, Spain and several other European Union countries.

Spinosad is being formulated as a creme rinse using excipients that are widely used and are "generally regarded as safe" (GRAS).

This study is intended to show the safety and efficacy of Spinosad 0.5% and 1.0%, as compared to the vehicle control in subjects 2 years of age and older with at least a mild infestation of pediculosis capitis.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	120 participants
Allocation:	Randomized
Intervention Model:	Factorial Assignment
Masking:	Single
Primary Purpose:	Treatment
Official Title:	Phase 2 Study of Efficacy and Safety of Different Strengths of Spinosad Topical Creme Rinse (0%, 0.5% or 1.0%) in Subjects 2 Years of Age or Older With Pediculosis Capitis - A Dose Ranging Study
Study Start Date :	March 2006
Study Completion Date :	July 2006

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Efficacy variable: The presence/absence of live lice and/or nits at Day 7 and Day 14.
2. Safety Analyses: The assessment of safety will be based on frequency of adverse events and on the scalp evaluations for irritation.

Eligibility Criteria

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Ages Eligible for Study:	2 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

1. Subject must have head lice infestation of at least a mild severity present at baseline of at least 3 live lice and the presence of nits;
2. Subject can be either male or female, 2 years or older
3. Subject must be in good general health, based on medical history.
4. Each subject must have a appropriately signed informed consent.
5. The parent or guardian of a child subject must be willing to allow other household members to be screened for head lice. If other household members are found to have a head lice infestation, they should also be enrolled in the study. If other household members are not willing to enroll in the study or do not qualify for enrollment, they must be willing to use the standard course of OTC lice treatment at home.
6. Subjects must agree to not use any other form of lice treatment during the course of the study. Subjects must also agree not to use a lice comb during the course of the study.
7. Subjects must agree not to cut or chemically treat their hair in the period between the Baseline treatment and the Day 14 visit.

Exclusion Criteria:

1. Individuals with history of irritation or sensitivity to pediculicides or hair care products.
2. Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, will interfere with the evaluation.
3. Individuals previously treated with a pediculicide within the 4 weeks prior to the study.
4. Individuals who have used hair dyes, bleaches, permanent wave or relaxing solutions within the past 2 weeks or during the study.
5. Individuals with a condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol.
6. Individuals receiving systemic or topical drugs or medications, including systemic antibiotics, which in the opinion of the investigative personnel may interfere with the study results.
7. Individuals who have participated in a clinical trial within the past 30 days.
8. Individuals who, in the opinion of the investigator, do not understand the subject requirements for study participation and/or may be likely to exhibit poor compliance.
9. Individuals with family members who are infested with lice but are unwilling or unable to enroll in the study or to ouse the standard course of lice treatment.
10. Females who are pregnant or nursing.
11. Sexually active females not using effective contraception.
12. Individuals who have a history of drug abuse in the past year.

Contacts and Locations

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Locations

United States, Arizona
Hill Top Resesarch
Scottsdale, Arizona, United States, 85251
United States, Florida
Hill Top Research
West Palm Beach, Florida, United States, 33409
United States, Ohio
Hill Top Research
Miamiville, Ohio, United States, 45147

Sponsors and Collaborators

ParaPRO LLC

Investigators

Principal Investigator:	Dyal Garg, PhD	Hill Top Research
Principal Investigator:	Robert Lewine, MD	Hill Top Research
Principal Investigator:	Michael Noss, MD	Hill Top Research

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier:	NCT00311779 History of Changes
Other Study ID Numbers:	SPN-202-06
First Posted:	April 6, 2006
Last Update Posted:	July 12, 2006
Last Verified:	July 2006

Keywords provided by ParaPRO LLC:

Pediculosis capitis; Head Lice; Crawlers; Ova

Additional relevant MeSH terms:

Lice Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic	Parasitic Diseases; Skin Diseases, Infectious; Skin Diseases