A Pilot Dose Ranging Study of Spinosad Creme Rinse | NCT00858481

Studies
A Pilot Dose Ranging Study of Spinosad Creme Rinse

NCT00858481

Sponsor

ParaPRO LLC

Status

Completed

Last Update Posted

Oct 20, 2015Estimated

Enrollment

36Actual

Phase

Phase 2

Conditions

Pediculosis Capitis
Head Lice

Interventions

Spinosad Creme Rinse - Vehicle Control
Spinosad Creme Rinse
Spinosad Creme Rinse
Spinosad Creme Rinse

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HTR-124235

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2005

Primary Completion Date

Nov 2005Actual

Completion Date

Nov 2005Actual

First Submitted Date

Mar 5, 2009

First Submission Date that Met QC Criteria

Mar 6, 2009

First Posted Date

Mar 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 19, 2015

Last Update Posted Date

Oct 20, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Placebo Comparator	Vehicle control	Drug: Spinosad Creme Rinse - Vehicle Control
2	Active Comparator	0.5% Spinosad creme rinse	Drug: Spinosad Creme Rinse
3	Active Comparator	1.0% Spinosad Creme Rinse	Drug: Spinosad Creme Rinse
4	Active Comparator	2.0% Spinosad Creme Rinse	Drug: Spinosad Creme Rinse

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Spinosad Creme Rinse - Vehicle Control	Drug	One or two, 10-minute topical applications (7 days apart)	1

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided