- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00528021
A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
June 2, 2022 updated by: Boston Scientific Corporation
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
230
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Florida City, Florida, United States, 33034
- Global Health Associates of Miami Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 4
|
Vehicle Only
|
Active Comparator: 1
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.
|
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
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.
|
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
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical Cure
Time Frame: Day 15 or 22
|
Count of participants with No live lice
|
Day 15 or 22
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
September 10, 2007
First Submitted That Met QC Criteria
September 10, 2007
First Posted (Estimate)
September 11, 2007
Study Record Updates
Last Update Posted (Actual)
June 28, 2022
Last Update Submitted That Met QC Criteria
June 2, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BCG20-0582-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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