A Pilot Dose Ranging Study of Spinosad Creme Rinse

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

Detailed Description
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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.

Official Title
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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

Conditions
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Pediculosis Capitis, Head Lice

Intervention / Treatment
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* Drug: Spinosad Creme Rinse - Vehicle Control
* Drug: Spinosad Creme Rinse
* Drug: Spinosad Creme Rinse
* Drug: Spinosad Creme Rinse


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Vehicle control | Drug: Spinosad Creme Rinse - Vehicle Control<br>* One or two, 10-minute topical applications (7 days apart)<br>|
| Active Comparator: 2<br>0.5% Spinosad creme rinse | Drug: Spinosad Creme Rinse<br>* 0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)<br>|
| Active Comparator: 3<br>1.0% Spinosad Creme Rinse | Drug: Spinosad Creme Rinse<br>* 1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)<br>|
| Active Comparator: 4<br>2.0% Spinosad Creme Rinse | Drug: Spinosad Creme Rinse<br>* 2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediculosis capitis, Head Lice