Head LicePhase 3NCT00301340
Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice
A Phase 3 study testing 5% Lice Asphyxiator lotion - Summers Laboratories, Inc. in people with Head Lice, run by Summers Laboratories at 5 sites in United States.
Trial summary
Summers Laboratories has developed a non-pesticide treatment for head lice. Lice Asphyxiator (L.A.) works by mechanically blocking the respiratory spiracles of the head lice, therefore causing a quick-acting suffocation that will not result in the development of resistance. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Head Lice
- What is being tested?
- 5% Lice Asphyxiator lotion - Summers Laboratories, Inc.
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2006to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females 6 months of age or older.
- Have an active infestation with Pediculus capitis, the human head louse, with at least three live lice at baseline, or treatment failure with any live lice from Protocol SU-01-2005 or Protocol SU-02-2005.
- Agree not to use any other pediculicides or medicated hair grooming products during the duration of the study.
- Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period.
- Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form.
- Subject or guardian has read, understood, and signed appropriate informed consent in English. If English is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language.
- Subject is willing to participate in the study, and abide by the protocol requirements.
- -
Who cannot join
- Participation in any clinical study, excluding protocols SU-01-2005 and SU-02-2005, within the past 30 days.
- Known hypersensitivity to any ingredient in the product formulation.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dermatology Research Associates 7691 Five Mile Road, Suite 312
Cincinnati, Ohio, 45230
Alegent Health, Harmony Street, 2nd Floor
Council Bluffs, Iowa, 51503-3147
Wee Care Pediatrics, 1580 West Antelope Drive, Suite 100
Layton, Utah, 84041
Diagnostic Clinic of Longview, TX 707 Hollybrook Drive
Longview, Texas, 75605
Global Health Associates of Miami 7800, SW 57 Avenue, Suite 219E
Miami, Florida, 33143
About this study
Official title: An Open Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the Treatment of Head Lice
Summers Laboratories has developed a non-pesticide treatment for head lice. Lice Asphyxiator (L.A.) works by mechanically blocking the respiratory spiracles of the head lice, therefore causing a quick-acting suffocation that will not result in the development of resistance.
The objectives of this open label study are to evaluate the efficacy and safety of home use of two 10-minute treatments of 5% L.A. (applied one week apart).
- Conditions
- Head Lice
- Being tested
- 5% Lice Asphyxiator lotion - Summers Laboratories, Inc.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% Lice Asphyxiator lotion - Summers Laboratories, Inc.Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2006 (estimated)
- Study startMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head LiceStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Summers Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Terri Meinking, Principal investigator, Global Health Association of MiamiAnne Lucky, Dr., Principal investigator, Dermatology Research AssociatesJon Thomas, Dr., Principal investigator, Alegent HealthE.A. Clark, Dr., Principal investigator, Diagnostic Clinic of Longview, TxPeter E Silas, Dr., Principal investigator, Advanced Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00301340
- Sponsor's protocol ID
- SU-03-2005
- Status last verified
- May 2007
- First submitted
- 8 Mar 2006
- Last updated
- 30 May 2007
- Results posted
- No
Publications
Meinking TL, Villar ME, Vicaria M, Eyerdam DH, Paquet D, Mertz-Rivera K, Rivera HF, Hiriart J, Reyna S. The clinical trials supporting benzyl alcohol lotion 5% (Ulesfia): a safe and effective topical treatment for head lice (pediculosis humanus capitis). Pediatr Dermatol. 2010 Jan-Feb;27(1):19-24. doi: 10.1111/j.1525-1470.2009.01059.x.
PubMed 20199404
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the Treatment of Head Lice
- ClinicalTrials.gov ID
- NCT00301340
- Acronym / sponsor ID
- SU-03-2005
- Conditions
- Head Lice
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Summers LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- First posted
- 10 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Summers Laboratories has developed a non-pesticide treatment for head lice. Lice Asphyxiator (L.A.) works by mechanically blocking the respiratory spiracles of the head lice, therefore causing a quick-acting suffocation that will not result in the development of resistance.
The objectives of this open label study are to evaluate the efficacy and safety of home use of two 10-minute treatments of 5% L.A. (applied one week apart).
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females 6 months of age or older.
- Have an active infestation with Pediculus capitis, the human head louse, with at least three live lice at baseline, or treatment failure with any live lice from Protocol SU-01-2005 or Protocol SU-02-2005.
- Agree not to use any other pediculicides or medicated hair grooming products during the duration of the study.
- Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period.
- Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form.
Key exclusion criteria (2 listed)
- Participation in any clinical study, excluding protocols SU-01-2005 and SU-02-2005, within the past 30 days.
- Known hypersensitivity to any ingredient in the product formulation.
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 |
|---|---|---|
| 5% Lice Asphyxiator lotion - Summers Laboratories, Inc. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2007.
- Derived from this study: PubMed 20199404Meinking TL, Villar ME, Vicaria M, Eyerdam DH, Paquet D, Mertz-Rivera K, Rivera HF, Hiriart J, Reyna S. The clinical trials supporting benzyl alcohol lotion 5% (Ulesfia): a safe and effective topical treatment for head lice (pediculosis humanus capitis). Pediatr Dermatol. 2010 Jan-Feb;27(1):19-24. doi: 10.1111/j.1525-1470.2009.01059.x.
- Related InfoLink provided by the sponsor.
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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.
Terri Meinking principal investigator
Global Health Association of Miami
Anne Lucky, Dr. principal investigator
Dermatology Research Associates
Jon Thomas, Dr. principal investigator
Alegent Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5% Lice Asphyxiator lotion - Summers Laboratories, Inc. in people with Head Lice, run by Summers Laboratories at 5 sites 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 8 inclusion and 2 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 30 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00301340, which also lists 1 linked publication.
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 30 May 2007.