NCT00858481

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
Last Updated

October 20, 2015

Status Verified

October 1, 2015

Enrollment Period

2 months

First QC Date

March 5, 2009

Last Update Submit

October 19, 2015

Conditions

Pediculosis CapitisHead Lice

Keywords

Pediculosis capitisHead Lice

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.

    14 days

Study Arms (4)

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

Spinosad Creme Rinse - Vehicle ControlDRUG

One or two, 10-minute topical applications (7 days apart)

1
Spinosad Creme RinseDRUG

0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)

2

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hill Top Research

West Palm Beach, Florida, 33409, United States

Location

Study Officials

  • Dyal Garg, Ph.D.

    Hill Top Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 9, 2009

Study Start

September 1, 2005

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

October 20, 2015

Record last verified: 2015-10

Locations

US(1)