Back to resultsA Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
Primary Purpose
Pediculus Humanus Capitis, Head Lice
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
BGC20-0582
Sponsored by
About this trial
This is an interventional treatment trial for Pediculus Humanus Capitis focused on measuring Head Lice, Lice Infestation, Pediculosis, Pediculosis Capitis
Eligibility Criteria
Inclusion Criteria:
- The subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent.
- Male or female subjects who are between the ages of 2 years (24 months) and 70 years old when consent is signed.
- Infestation with head lice as demonstrated by the presence of live lice prior to first treatment.
- Willing and able to attend all study visits as scheduled.
- Females of childbearing potential must have a negative urine pregnancy test at screening and before receiving a second treatment, if necessary.
Exclusion Criteria:
- Subject and/or legal guardian has not signed informed consent.
- Subject was treated for pediculosis within 2 weeks prior to the screening evaluation.
- Subject with an infestation of body lice or pubic lice.
- 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.
- Subject with other diagnoses which, in the opinion of the investigator, would interfere with efficacy or safety assessments or would preclude study participation.
- Subject with very short (shaved) hair.
- Subject who will not be available for follow up visits.
- Subject has been treated with a systemic antibiotic within the previous two weeks before screening.
- 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.
- 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.
- Pregnant and/or nursing females.
Sites / Locations
- Global Health Associates of Miami Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 2.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 10% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 12.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
Outcomes
Primary Outcome Measures
Clinical Cure
Count of participants with No live lice
Secondary Outcome Measures
Full Information
NCT ID
NCT00528021
First Posted
September 10, 2007
Last Updated
June 2, 2022
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00528021
Brief Title
A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
Official Title
A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediculus Humanus Capitis, Head Lice
Keywords
Head Lice, Lice Infestation, Pediculosis, Pediculosis Capitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
230 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 2.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 10% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
Arm Title
3
Arm Type
Active Comparator
Arm Description
Subjects are treated either once (day1) or twice (day 1 and 7) with either placebo or 12.5% BGC20-0582 topically. Following application of the BGC20-0582 lice treatment gel or placebo, the product is rinsed from the subject's hair.
Arm Title
4
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Vehicle Only
Intervention Type
Drug
Intervention Name(s)
BGC20-0582
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinical Cure
Description
Count of participants with No live lice
Time Frame
Day 15 or 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent.
Male or female subjects who are between the ages of 2 years (24 months) and 70 years old when consent is signed.
Infestation with head lice as demonstrated by the presence of live lice prior to first treatment.
Willing and able to attend all study visits as scheduled.
Females of childbearing potential must have a negative urine pregnancy test at screening and before receiving a second treatment, if necessary.
Exclusion Criteria:
Subject and/or legal guardian has not signed informed consent.
Subject was treated for pediculosis within 2 weeks prior to the screening evaluation.
Subject with an infestation of body lice or pubic lice.
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.
Subject with other diagnoses which, in the opinion of the investigator, would interfere with efficacy or safety assessments or would preclude study participation.
Subject with very short (shaved) hair.
Subject who will not be available for follow up visits.
Subject has been treated with a systemic antibiotic within the previous two weeks before screening.
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.
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.
Pregnant and/or nursing females.
Facility Information:
Facility Name
Global Health Associates of Miami Inc
City
Florida City
State/Province
Florida
ZIP/Postal Code
33034
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
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