Pediculus Humanus CapitisPhase 2NCT00528021
A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
A Phase 2 study testing BGC20-0582 in people with Pediculus Humanus Capitis and Head Lice, run by Boston Scientific Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 70 years
- Conditions the study is for
- Pediculus Humanus Capitis, Head Lice
- What is being tested?
- BGC20-0582
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jun 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Global Health Associates of Miami Inc
Florida City, Florida, 33034
About this study
The main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.
Read the 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.
- Conditions
- Pediculus Humanus Capitis, Head Lice
- Being tested
- Placebo, BGC20-0582
- Keywords
- Head Lice, Lice Infestation, Pediculosis, Pediculosis Capitis
- Medical subject headings
- Lice Infestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Vehicle Only
BGC20-0582Drug
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 group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 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. Receives: Drug: BGC20-0582 |
| 2 | Active comparator | 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. Receives: Drug: BGC20-0582 |
| 3 | Active comparator | 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. Receives: Drug: BGC20-0582 |
| 4 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure
Count of participants with No live lice
Measured: Day 15 or 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionMay 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediculus Humanus CapitisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00528021
- Sponsor's protocol ID
- BCG20-0582-001
- Status last verified
- Jun 2022
- First submitted
- 10 Sep 2007
- Last updated
- 28 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Safety and Efficacy of BGC20-0582 Lice Treatment Gel for Head Lice Infestation
- ClinicalTrials.gov ID
- NCT00528021
- Acronym / sponsor ID
- BCG20-0582-001
- Conditions
- Pediculus Humanus Capitis, Head Lice
- Keywords
- Head Lice, Lice Infestation, Pediculosis, Pediculosis Capitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- May 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 11 Sep 2007 (estimated)
- Results
- Posted 28 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: BGC20-0582Subjects 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. |
| 2 | Active comparator | Drug: BGC20-0582Subjects 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. |
| 3 | Active comparator | Drug: BGC20-0582Subjects 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. |
| 4 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 2 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboVehicle Only | Drug | 4 |
| BGC20-0582BGC20-0582 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. | Drug | 1, 2, 3 |
Primary outcome
Clinical Cure
Time frame: Day 15 or 22
Count of participants with No live lice
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BGC20-0582 in people with Pediculus Humanus Capitis and Head Lice, run by Boston Scientific Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Cure (time frame: Day 15 or 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.