A Pilot Dose Ranging Study of Spinosad Creme Rinse

This study has been completed.
Sponsor:
Information provided by:
ParaPRO LLC
ClinicalTrials.gov Identifier:
NCT00858481
First received: March 5, 2009
Last updated: March 6, 2009
Last verified: March 2009
  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:


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
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
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

No publications provided

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: March 6, 2009
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 April 15, 2014