CompletedNCT00858481Updated Oct 20, 2015

A Pilot Dose Ranging Study of Spinosad Creme Rinse

A Phase 2 interventional study of Spinosad Creme Rinse - Vehicle Control and Spinosad Creme Rinse in Pediculosis Capitis and Head Lice, sponsored by ParaPRO LLC. Completed at 1 site in United States. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-20.

Sponsored by ParaPRO LLC · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 36
Allocation: Randomized
Ages: 2 Years and older
Sex: All

Study summary

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

Read the 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.

Conditions studied

Pediculosis Capitis
Head Lice

Browse trials for

Lice Infestations 58

Keywords

Pediculosis capitis
Head Lice

Who can participate

Ages eligible: 2 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Outcomes assessor)
Enrollment: 36 participants (actual)

Study arms

Placebo comparator
1
Vehicle control
Drug: Spinosad Creme Rinse - Vehicle Control
Active comparator
2
0.5% Spinosad creme rinse
Drug: Spinosad Creme Rinse
Active comparator
3
1.0% Spinosad Creme Rinse
Drug: Spinosad Creme Rinse
Active comparator
4
2.0% Spinosad Creme Rinse
Drug: Spinosad Creme Rinse

Interventions

DrugSpinosad Creme Rinse - Vehicle Control
One or two, 10-minute topical applications (7 days apart)
DrugSpinosad Creme Rinse
0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
DrugSpinosad Creme Rinse
1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
DrugSpinosad Creme Rinse
2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart)

What researchers measure

Primary outcomes

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

Secondary outcomes

Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.
Time frame: 14 days

Study locations

1 site

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

Registry details

Key details

Study ID: NCT00858481
Lead sponsor: ParaPRO LLC
First posted: Mar 9, 2009
Start date: Sep 2005
Primary completion: Nov 2005
Completion: Nov 2005
Last update: Oct 20, 2015

Study contacts

Dyal Garg, Ph.D.

principal investigator · Hill Top Research

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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