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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


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
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