A Pilot Dose Ranging Study of Spinosad Creme Rinse

Head Lice Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00858481
• Other study ID #: SPN-201-05
• Secondary ID: HTR-124235
• Status: Completed
• Phase: Phase 2
• First received: March 5, 2009
• Last updated: October 19, 2015
• Start date: September 2005
• Est. completion date: November 2005

Study information

• Verified date: October 2015
• Source: ParaPRO LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head Lice
• Lice Infestations
• Pediculosis Capitis

Intervention

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

Locations

Country	Name	City	State
United States	Hill Top Research	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
ParaPRO LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation.		14 days	Yes