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A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00528021
Recruitment Status : Completed
First Posted : September 11, 2007
Results First Posted : December 28, 2010
Last Update Posted : December 28, 2010
Sponsor:
Information provided by:
BTG International Inc.

Tracking Information
First Submitted Date  ICMJE September 10, 2007
First Posted Date  ICMJE September 11, 2007
Results First Submitted Date  ICMJE February 20, 2009
Results First Posted Date  ICMJE December 28, 2010
Last Update Posted Date December 28, 2010
Study Start Date  ICMJE August 2007
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2010)
Clinical Cure [ Time Frame: Day 15 or 22 ]
No live lice 14 days following last treatment
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00528021 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
Official Title  ICMJE A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
Brief Summary The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.
Detailed Description The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Pediculus Humanus Capitis
  • Head Lice
Intervention  ICMJE
  • Drug: Placebo
    Vehicle Only
  • Drug: BGC20-0582
    BGC20-0582 is a topical gel formulation of a naturally derived product. Subjects are treated either once (day 1) or twice (day 1 and 7) with either placebo or BGC20-0582 at one of the three concentrations. Following application of the BGC20-0582 lice treatment gel of placebo the product is rinsed from the subjects hair.
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: BGC20-0582
  • Active Comparator: 2
    Intervention: Drug: BGC20-0582
  • Active Comparator: 3
    Intervention: Drug: BGC20-0582
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2010)
230
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date May 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent.
  2. Male or female subjects who are between the ages of 2 years (24 months) and 70 years old when consent is signed.
  3. Infestation with head lice as demonstrated by the presence of live lice prior to first treatment.
  4. Willing and able to attend all study visits as scheduled.
  5. Females of childbearing potential must have a negative urine pregnancy test at screening and before receiving a second treatment, if necessary.

Exclusion Criteria:

  1. Subject and/or legal guardian has not signed informed consent.
  2. Subject was treated for pediculosis within 2 weeks prior to the screening evaluation.
  3. Subject with an infestation of body lice or pubic lice.
  4. Subject is suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment, which in the opinion of the investigator and visiting physician could influence the results of the study.
  5. Subject with other diagnoses which, in the opinion of the investigator, would interfere with efficacy or safety assessments or would preclude study participation.
  6. Subject with very short (shaved) hair.
  7. Subject who will not be available for follow up visits.
  8. Subject has been treated with a systemic antibiotic within the previous two weeks before screening.
  9. Subject has been previously enrolled in any clinical study within the past 30 days; subject may not participate in another study while participating in this study.
  10. Subject with history of allergy/sensitivity to active ingredient or related products; or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids.
  11. Pregnant and/or nursing females.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00528021
Other Study ID Numbers  ICMJE BCG20-0582-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tom Logan, BTG
Study Sponsor  ICMJE BTG International Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor BTG International Inc.
PRS Account BTG International Inc.
Verification Date November 2010

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