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

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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.

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.

Condition or disease Intervention/treatment Phase
Pediculus Humanus Capitis Head Lice Drug: Placebo Drug: BGC20-0582 Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
Study Start Date : August 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1 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.

Active Comparator: 2 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.

Active Comparator: 3 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.

Placebo Comparator: 4 Drug: Placebo
Vehicle Only




Primary Outcome Measures :
  1. Clinical Cure [ Time Frame: Day 15 or 22 ]
    No live lice 14 days following last treatment



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Ages Eligible for Study:   2 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528021


Locations
United States, Florida
Global Health Associates of Miami Inc
Florida City, Florida, United States, 33034
Sponsors and Collaborators
BTG International Inc.
Investigators
Study Director: Medical Monitor BTG International Inc.

Responsible Party: Tom Logan, BTG
ClinicalTrials.gov Identifier: NCT00528021     History of Changes
Other Study ID Numbers: BCG20-0582-001
First Posted: September 11, 2007    Key Record Dates
Results First Posted: December 28, 2010
Last Update Posted: December 28, 2010
Last Verified: November 2010

Keywords provided by BTG International Inc.:
Head Lice
Lice Infestation
Pediculosis
Pediculosis Capitis

Additional relevant MeSH terms:
Lice Infestations
Parasitic Diseases
Ectoparasitic Infestations
Skin Diseases, Parasitic
Skin Diseases, Infectious
Skin Diseases