Pediculus CapitisNCT02997904
A Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit on Pediatric and Adult Subjects
A study testing Apply Liquid Then Comb Out in people with Pediculus Capitis, run by Piedmont Pharmaceuticals, LLC at 1 site in United States.
Trial summary
A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically superior to a sham control with one hour of combing. Read more about this study
- Who is it for?
- Ages 2 to 90 years
- Conditions the study is for
- Pediculus Capitis
- What is being tested?
- Apply Liquid Then Comb Out
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Feb 2017
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Must have active head lice infestations (at least 1 live louse and eggs)
- Good general health based on medical history
- Each subject has to be consented
Who cannot join
- Subjects with any condition that would compromise the study
- History of irritation or sensitivity to pediculicides or hair care products
- Subjects with cranial or facial implants
- Subjects who have received radiation within the last 6 months
- Subjects with history of heart disease
- Subjects with history of epilepsy or seizure disorders
Show all 12Show fewer
- Subjects with neuro-stimulator or pacemaker
- Subject with hair that staff cannot comb
- Subject previously treated in study in last 30 days
- Use of lice treatment in past 2 weeks
- Subject unable to sense pain
- Subject unable to communicate pain
Trial locations and contacts
1 site in 1 country.
United States1 site
Lice Solution Resource Network Research
West Palm Beach, Florida, 33407
About this study
Official title: A Randomized Sham Controlled Double Blinded Single Site Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit for the Removal of Human Head Lice and Eggs on Pediatric and Adult Subjects
A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically superior to a sham control with one hour of combing.
Read the detailed description
Resultz Lice and Egg Elimination Kit will be efficacious in the removal of human head lice infestations in children and adult subjects under simulated real world conditions.
- Conditions
- Pediculus Capitis
- Being tested
- Apply Liquid Then Comb Out
- Keywords
- lice comb, human head lice infestations, combing solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apply Liquid Then Comb OutDevice
Also called Resultz Application
Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour
| Study group | Role | What they receive |
|---|---|---|
| Resultz Lice and Egg Elimination Kit | Experimental | Resultz combing solution, head lice comb and instructions for use in a kit: apply liquid then comb out for 1 hour Receives: Device: Apply Liquid Then Comb Out |
| Placebo Lice and Egg Elimination Kit | Placebo comparator | 20% glycerin combing solution, comb and instructions for use in a kit: apply liquid then comb out for 1 hour Receives: Device: Apply Liquid Then Comb Out |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing
A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.
Measured: 1 hour
Secondary outcomes (1)
Total Number of Lice Removed, Total Number of Eggs Removed
Total number of lice removed after one hour of combing and total number of eggs removed after one hour of combing, analyzed separately
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2017
- Study completionFeb 2017
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 CapitisStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piedmont Pharmaceuticals, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lice Solutions Resource Network (LSRN) Research
- Responsible party
- Sponsor
- Investigators
- Katie Shepherd, Principal investigator, Lice Solutions Resource Network Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997904
- Sponsor's protocol ID
- PP-16-001
- Status last verified
- Jul 2017
- First submitted
- 16 Dec 2016
- Last updated
- 31 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Sham Controlled Double Blinded Single Site Clinical Trial Evaluating the Efficacy of Resultz Lice and Egg Elimination Kit for the Removal of Human Head Lice and Eggs on Pediatric and Adult Subjects
- ClinicalTrials.gov ID
- NCT02997904
- Acronym / sponsor ID
- PP-16-001
- Conditions
- Pediculus Capitis
- Keywords
- lice comb, human head lice infestations, combing solution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Piedmont Pharmaceuticals, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Lice Solutions Resource Network (LSRN) Research
- Study start
- Dec 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Posted 31 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A one day study to demonstrate that Resultz Lice and Egg Elimination Kit is statistically superior to a sham control with one hour of combing.
Detailed description
Resultz Lice and Egg Elimination Kit will be efficacious in the removal of human head lice infestations in children and adult subjects under simulated real world conditions.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resultz Lice and Egg Elimination Kit | Experimental | Device: Apply Liquid Then Comb OutResultz combing solution, head lice comb and instructions for use in a kit: apply liquid then comb out for 1 hour |
| Placebo Lice and Egg Elimination Kit | Placebo comparator | Device: Apply Liquid Then Comb Out20% glycerin combing solution, comb and instructions for use in a kit: apply liquid then comb out for 1 hour |
Who may qualify
- Ages
- 2 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Must have active head lice infestations (at least 1 live louse and eggs)
- Good general health based on medical history
- Each subject has to be consented
Key exclusion criteria (12 listed)
- Subjects with any condition that would compromise the study
- History of irritation or sensitivity to pediculicides or hair care products
- Subjects with cranial or facial implants
- Subjects who have received radiation within the last 6 months
- Subjects with history of heart disease
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 |
|---|---|---|
| Apply Liquid Then Comb OutAlso: Resultz ApplicationApply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour | Device | Placebo Lice and Egg Elimination Kit, Resultz Lice and Egg Elimination Kit |
Primary outcome
The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing
Time frame: 1 hour
A superiority analysis comparing the total number of lice + eggs removed from the head after one hour of combing with the Resultz Kit versus the control. The Resultz Kit was considered a success if the Resultz Kit was superior to the control.
1 secondary outcome
Total Number of Lice Removed, Total Number of Eggs Removed
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Katie Shepherd principal investigator
Lice Solutions Resource Network Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apply Liquid Then Comb Out in people with Pediculus Capitis, run by Piedmont Pharmaceuticals, LLC 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 3 inclusion and 12 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 31 Aug 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2017). 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?
The Total Number of Lice + Eggs Removed From the Head After One Hour of Combing (time frame: 1 hour). 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 31 Aug 2017.