A Pilot Dose Ranging Study of Spinosad Creme Rinse

ParaPRO

Status and phase: Completed; Phase 2

Conditions: Head Lice; Pediculosis Capitis

Treatments: Drug: Spinosad Creme Rinse - Vehicle Control; Drug: Spinosad Creme Rinse

Study type: Interventional

Funder types: Industry

Identifiers

NCT00858481

SPN-201-05

HTR-124235

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 2+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 4 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Vehicle control

Treatment:

Drug: Spinosad Creme Rinse - Vehicle Control

2

Active Comparator group

Description:

0.5% Spinosad creme rinse

Treatment:

Drug: Spinosad Creme Rinse

Drug: Spinosad Creme Rinse

Drug: Spinosad Creme Rinse

3

Active Comparator group

Description:

1.0% Spinosad Creme Rinse

Treatment:

Drug: Spinosad Creme Rinse

Drug: Spinosad Creme Rinse

Drug: Spinosad Creme Rinse

4

Active Comparator group

Description:

2.0% Spinosad Creme Rinse

Treatment:

Drug: Spinosad Creme Rinse

Drug: Spinosad Creme Rinse

Drug: Spinosad Creme Rinse