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

March 5, 2009
March 6, 2009
September 2005
November 2005   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00858481 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Pilot Dose Ranging Study of Spinosad Creme Rinse
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Pediculosis Capitis
  • Head Lice
  • Drug: Spinosad Creme Rinse - Vehicle Control
    One or two, 10-minute topical applications (7 days apart)
  • Drug: Spinosad Creme Rinse
    0.5% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
  • Drug: Spinosad Creme Rinse
    1.0% Spinosad Creme Rinse: one or two, 10-minute topical applications (7 days apart)
  • Drug: Spinosad Creme Rinse
    2.0% Spinosad Creme Rinse - one or two, 10-minute topical applications (7 days apart)
  • Placebo Comparator: 1
    Vehicle control
    Intervention: Drug: Spinosad Creme Rinse - Vehicle Control
  • Active Comparator: 2
    0.5% Spinosad creme rinse
    Intervention: Drug: Spinosad Creme Rinse
  • Active Comparator: 3
    1.0% Spinosad Creme Rinse
    Intervention: Drug: Spinosad Creme Rinse
  • Active Comparator: 4
    2.0% Spinosad Creme Rinse
    Intervention: Drug: Spinosad Creme Rinse
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
November 2005
November 2005   (final data collection date for primary outcome measure)

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
Both
2 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00858481
SPN-201-05, HTR-124235
No
Dyal Garg, Ph.D., Principal Investigator, Hill Top Research
ParaPRO LLC
Not Provided
Principal Investigator: Dyal Garg, Ph.D. Hill Top Research
ParaPRO LLC
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP