A Pilot Dose Ranging Study of Spinosad Creme Rinse

Efficacy and Safety of Different Strengths of Spinosad Topical Creme (0%, 0.5%, 1.0% or 2%) in Subjects With Pediculosis Capitis - a Dose Ranging Study

A pilot dose ranging study to evaluate the safety and efficacy of different strengths of Spinosad Creme versus a vehicle control.

Study Overview

• Status: Completed
• Conditions: Head Lice; Pediculosis Capitis
• Intervention / Treatment: Drug: Spinosad Creme Rinse - Vehicle Control; Drug: Spinosad Creme Rinse; Drug: Spinosad Creme Rinse; Drug: Spinosad Creme Rinse

Detailed Description

A Phase 2a, randomized, single investigational site, investigator/evaluator-blind, four-arm, parallel-group, vehicle-controlled, pilot study to evaluate the safety and efficacy of different strengths of Spinosad Creme rinse verses vehicle control.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • West Palm Beach, Florida, United States, 33409
      • Hill Top Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Active head lice infestation
• Male or female, 2 years of age or older
• Good general health
• Appropriately signed Informed Consent
• Subject agreement to not use any other form of lice treatment during the course of the study
• Subject agreement to not cut or chemically treat their hair between visits

Exclusion Criteria:

• History of irritation or sensitivity to pediculicides or hair care products
• Individuals with any visible skin/scalp condition that would interfere with the evaluation
• Individuals previously treated with a pediculicide within 4 weeks prior to study enrollment
• Individuals using hair dyes, bleaches, permanent waves or relaxing solutions 2 weeks prior to study enrollment
• Individuals who have participated in any clinical trial within 30 days of enrollment
• Individuals with family members who were infested with lice but were unwilling or unable to enroll in the study or use a standard course of lice treatment
• Females who were pregnant or nursing
• Sexually active females not using effective contraception

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 1; Vehicle control	Drug: Spinosad Creme Rinse - Vehicle Control; One or two, 10-minute topical applications (7 days apart)
ACTIVE_COMPARATOR: 2; 0.5% Spinosad creme rinse	Drug: Spinosad Creme Rinse; 0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart); Drug: Spinosad Creme Rinse; 1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart); Drug: Spinosad Creme Rinse; 2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart)
ACTIVE_COMPARATOR: 3; 1.0% Spinosad Creme Rinse	Drug: Spinosad Creme Rinse; 0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart); Drug: Spinosad Creme Rinse; 1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart); Drug: Spinosad Creme Rinse; 2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart)
ACTIVE_COMPARATOR: 4; 2.0% Spinosad Creme Rinse	Drug: Spinosad Creme Rinse; 0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart); Drug: Spinosad Creme Rinse; 1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart); Drug: Spinosad Creme Rinse; 2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of various doses of Spinosad, based on the presence or absence of live lice at 7 and 14 days post-treatment. The efficacy evaluation was performed by a trained evaluator.	14 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.	14 days

Collaborators and Investigators

• Sponsor: ParaPRO LLC
• Investigators: Principal Investigator: Dyal Garg, Ph.D., Hill Top Research

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (ACTUAL): November 1, 2005
• Study Completion (ACTUAL): November 1, 2005

Study Registration Dates

• First Submitted: March 5, 2009
• First Submitted That Met QC Criteria: March 6, 2009
• First Posted (ESTIMATE): March 9, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 20, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Head Lice; Pediculosis capitis
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations
• Other Study ID Numbers: SPN-201-05; HTR-124235