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

NCT00311779 | Completed Phase 2

• 1 other identifier: SPN-202-06
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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).

Conditions

Pediculosis Capitis (Head Lice)

Keywords

Pediculosis capitis; Head Lice; Crawlers; Ova

Outcome Measures

Primary Outcomes (2)

• Efficacy variable: The presence/absence of live lice and/or nits at Day 7 and Day 14.

• Safety Analyses: The assessment of safety will be based on frequency of adverse events and on the scalp evaluations for irritation.

Interventions

Spinosad Creme Rinse DRUG

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Subject can be either male or female, 2 years or older
• Subject must be in good general health, based on medical history.
• Each subject must have a appropriately signed informed consent.
• 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.
• 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.
• Subjects must agree not to cut or chemically treat their hair in the period between the Baseline treatment and the Day 14 visit.

You may not qualify if:

• Individuals with history of irritation or sensitivity to pediculicides or hair care products.
• Individuals with any visible skin/scalp condition at the treatment site which, in the opinion of the investigative personnel, will interfere with the evaluation.
• Individuals previously treated with a pediculicide within the 4 weeks prior to the study.
• Individuals who have used hair dyes, bleaches, permanent wave or relaxing solutions within the past 2 weeks or during the study.
• Individuals with a condition or illness that, in the opinion of the investigator, may compromise the objective of the protocol.
• 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.
• Individuals who have participated in a clinical trial within the past 30 days.
• 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.
• 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.
• Females who are pregnant or nursing.
• Sexually active females not using effective contraception.
• Individuals who have a history of drug abuse in the past year.

Sponsors & Collaborators

• ParaPRO LLC: lead

Study Sites (3)

Hill Top Resesarch

Scottsdale, Arizona, 85251, United States

Location

Hill Top Research

West Palm Beach, Florida, 33409, United States

Location

Hill Top Research

Miamiville, Ohio, 45147, United States

Location

Study Officials

• Dyal Garg, PhD

  Hill Top Research

  PRINCIPAL INVESTIGATOR

• Robert Lewine, MD

  Hill Top Research

  PRINCIPAL INVESTIGATOR

• Michael Noss, MD

  Hill Top Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 4, 2006
• First Posted: April 6, 2006
• Study Start: March 1, 2006
• Study Completion: July 1, 2006
• Last Updated: July 12, 2006

Record last verified: 2006-07

Locations

US (3)