A Pilot Dose Ranging Study of Spinosad Creme Rinse - Full Text View

Purpose

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

Condition	Intervention	Phase
Pediculosis Capitis Head Lice	Drug: Spinosad Creme Rinse - Vehicle Control Drug: Spinosad Creme Rinse	Phase 2


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

Resource links provided by NLM:

MedlinePlus related topics: Lice

Drug Information available for: Spinosad

U.S. FDA Resources

Further study details as provided by ParaPRO LLC:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety of various doses of Spinosad, based on the occurrence of adverse events, especially scalp irritation. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]


Enrollment:	36
Study Start Date:	September 2005
Study Completion Date:	November 2005
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: 1 Vehicle control	Drug: Spinosad Creme Rinse - Vehicle Control One or two, 10-minute topical applications (7 days apart)
Active Comparator: 2 0.5% Spinosad creme rinse	Drug: Spinosad Creme Rinse 0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
Active Comparator: 3 1.0% Spinosad Creme Rinse	Drug: Spinosad Creme Rinse 1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
Active Comparator: 4 2.0% Spinosad Creme Rinse	Drug: Spinosad Creme Rinse 2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart)

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.

Eligibility


Ages Eligible for Study:	2 Years and older (Child, Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858481

Locations


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

Sponsors and Collaborators

ParaPRO LLC

Investigators


Principal Investigator:	Dyal Garg, Ph.D.	Hill Top Research

More Information


Responsible Party:	Dyal Garg, Ph.D., Principal Investigator, Hill Top Research
ClinicalTrials.gov Identifier:	NCT00858481 History of Changes
Other Study ID Numbers:	SPN-201-05 HTR-124235
Study First Received:	March 5, 2009
Last Updated:	October 19, 2015
Health Authority:	United States: Food and Drug Administration

Keywords provided by ParaPRO LLC:


Pediculosis capitis Head Lice

Additional relevant MeSH terms:


Lice Infestations Ectoparasitic Infestations Skin Diseases, Parasitic	Parasitic Diseases Skin Diseases, Infectious Skin Diseases

ClinicalTrials.gov processed this record on September 23, 2016