A Pilot Dose Ranging Study of Spinosad Creme Rinse

This study has been completed.

Sponsor:

Information provided by:

ParaPRO LLC

ClinicalTrials.gov Identifier:

NCT00858481

First received: March 5, 2009

Last updated: March 6, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 5, 2009

Last Updated Date

March 6, 2009

Start Date ^ICMJE

September 2005

Primary Completion Date

November 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00858481 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Pilot Dose Ranging Study of Spinosad Creme Rinse

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Pediculosis Capitis
Head Lice

Intervention ^ICMJE

Drug: Spinosad Creme Rinse - Vehicle Control
One or two, 10-minute topical applications (7 days apart)
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)

Study Arm (s)

Placebo Comparator: 1
Vehicle control

Intervention: Drug: Spinosad Creme Rinse - Vehicle Control
Active Comparator: 2
0.5% Spinosad creme rinse

Intervention: Drug: Spinosad Creme Rinse
Active Comparator: 3
1.0% Spinosad Creme Rinse

Intervention: Drug: Spinosad Creme Rinse
Active Comparator: 4
2.0% Spinosad Creme Rinse

Intervention: Drug: Spinosad Creme Rinse

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2005

Primary Completion Date

November 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

2 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00858481

Other Study ID Numbers ^ICMJE

SPN-201-05, HTR-124235

Has Data Monitoring Committee

Responsible Party

Dyal Garg, Ph.D., Principal Investigator, Hill Top Research

Study Sponsor ^ICMJE

ParaPRO LLC

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Dyal Garg, Ph.D.

Hill Top Research

Information Provided By

ParaPRO LLC

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top