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
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

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 September 30, 2014