PEDICULOSISPhase 3ESPXNCT01966965
Efficacy and Safety Study for PIOLIN® Shampoo
A Phase 3 study testing PIOLIN® and NEDAX in people with PEDICULOSIS, run by Phytopharm Consulting Brazil at 1 site in Brazil.
Trial summary
This study aims to demonstrate the therapeutic efficacy and safety of Shampoo PIOLIN ® in the treatment of human pediculosis. Will be treated 212 patients aged 2-60 years with the infestation, along with the people in your family life. All will be submitted to the dosing regimen recommended in the package insert. Read more about this study
- Who is it for?
- Ages 2 to 60 years
- Conditions the study is for
- PEDICULOSIS
- What is being tested?
- PIOLIN® and NEDAX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2014to Oct 2014
- 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 2 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Volunteers healthy female and male ;
- Children between 2 and 17 years ;
- Increased from 18 years;
- Availability of volunteer to maintain a stable weight during the study period (ranging from less than 2 kg) ;
- Displays lice infestation on clinical examination ;
- Voluntary participation ;
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- Signing the consent form and / or Free and Informed Consent ;
- Willingness to comply with study procedures ;
- Complying that researchers can make use of all the information nameless , including publication and comply with the use and storage of all information confidential .
Who cannot join
- Use paint or other chemicals on the hair in the last four weeks that precede the study ;
- Concomitant Therapy ;
- Women who are pregnant or intend to become pregnant during the study ;
- Infants ;
- Volunteers not willing to sign and adhere to the Statement of Consent ;
- Known hypersensitivity to the product ;
- Participation in any other clinical study ;
- Any other condition that the investigator decides that might interfere with the results or involving a risk to the volunteer study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Ubs Fatima
Pelotas, Rio Grande do Sul, 96075-540
MONICA M MENDES, MD MSc, 55 53 9155-2139, MONIKETHI@GMAIL.COM
MONICA M MENDES, MD MSc
About this study
Official title: Phase 3 Efficacy and Safety Study for PIOLIN® Shampoo to Treat Pediculosis
This study aims to demonstrate the therapeutic efficacy and safety of Shampoo PIOLIN ® in the treatment of human pediculosis. Will be treated 212 patients aged 2-60 years with the infestation, along with the people in your family life. All will be submitted to the dosing regimen recommended in the package insert. 100% of the sample shall be subjected to clinical evaluation through comb, pre and post treatment and monitored after thirty days for evaluation of safety and possible adverse effects that may arise related to any of the components of the formula.
The efficacy study is active comparator, non-inferiority.
- Conditions
- PEDICULOSIS
- Being tested
- PIOLIN®, NEDAX
- Keywords
- PIOLIN®, PEDICULOSIS, EFFICACY, SAFETY, PHYTOMEDICINE,, ARRUDA, RUTA
- Medical subject headings
- Lice Infestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIOLIN®Drug
Also called RUTA GRAVEOLENS STANDARDIZED FLUID EXTRACT
PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN
NEDAXDrug
Also called PERMETRIN
AS SPECIFIED AT THE LEAFLET
| Study group | Role | What they receive |
|---|---|---|
| PIOLIN® | Experimental | PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN Receives: Drug: PIOLIN® |
| NEDAX | Active comparator | FOLLOWING THE LEAFLET TREATMENT Receives: Drug: NEDAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFICACY
AFTER 17 DAYS OF TREATMENT PATIENTS SHOULD HAVE NO INFESTATION - clinically
Measured: 17 DAYS
Secondary outcomes (1)
SAFETY
IN THE END OF 30 DAYS TREATMENT PATIENTS WILL BE EVALUATED WITH BLOOD/URINE ANALYSIS FOR CHECKING ANY CHANGE - biochemistry, lab exams
Measured: 30 DAYS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startJul 2014
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PEDICULOSISStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phytopharm Consulting Brazil
- Sponsor type
- Research network
- Collaborators
- Laboratório Saúde Ltda - principal e único patrocinador
- Responsible party
- Principal investigator, Karla F. Deud Jose, Phytopharm Consulting Brazil
- Investigators
- MONICA M MENDES, MD MSc, Principal investigator, UCPEL-UNIVERSIDADE CATÓLICA DE PELOTASACHILLES GENTILINI NETO, MD, Study chair, INDEPENDENT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966965
- Sponsor's protocol ID
- ESPX2013
- Acronym
- ESPX
- Status last verified
- Oct 2013
- First submitted
- 17 Oct 2013
- Last updated
- 23 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Efficacy and Safety Study for PIOLIN® Shampoo to Treat Pediculosis
- ClinicalTrials.gov ID
- NCT01966965
- Acronym / sponsor ID
- ESPX / ESPX2013
- Conditions
- PEDICULOSIS
- Keywords
- PIOLIN®, PEDICULOSIS, EFFICACY, SAFETY, PHYTOMEDICINE,, ARRUDA, RUTA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Phytopharm Consulting BrazilResearch network
- Collaborators
- Laboratório Saúde Ltda - principal e único patrocinador
- Study start
- Jul 2014
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 22 Oct 2013 (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.
This study aims to demonstrate the therapeutic efficacy and safety of Shampoo PIOLIN ® in the treatment of human pediculosis. Will be treated 212 patients aged 2-60 years with the infestation, along with the people in your family life. All will be submitted to the dosing regimen recommended in the package insert. 100% of the sample shall be subjected to clinical evaluation through comb, pre and post treatment and monitored after thirty days for evaluation of safety and possible adverse effects that may arise related to any of the components of the formula.
The efficacy study is active comparator, non-inferiority.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PIOLIN® | Experimental | Drug: PIOLIN®PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN |
| NEDAX | Active comparator | Drug: NEDAXFOLLOWING THE LEAFLET TREATMENT |
Who may qualify
- Ages
- 2 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Volunteers healthy female and male ;
- Children between 2 and 17 years ;
- Increased from 18 years;
- Availability of volunteer to maintain a stable weight during the study period (ranging from less than 2 kg) ;
- Displays lice infestation on clinical examination ;
Key exclusion criteria (8 listed)
- Use paint or other chemicals on the hair in the last four weeks that precede the study ;
- Concomitant Therapy ;
- Women who are pregnant or intend to become pregnant during the study ;
- Infants ;
- Volunteers not willing to sign and adhere to the Statement of Consent ;
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 |
|---|---|---|
| PIOLIN®Also: RUTA GRAVEOLENS STANDARDIZED FLUID EXTRACTPIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN | Drug | PIOLIN® |
| NEDAXAlso: PERMETRINAS SPECIFIED AT THE LEAFLET | Drug | NEDAX |
Primary outcome
EFFICACY
Time frame: 17 DAYS
AFTER 17 DAYS OF TREATMENT PATIENTS SHOULD HAVE NO INFESTATION - clinically
1 secondary outcome
SAFETY
Time frame: 30 DAYS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2013.
- Brazilian researchers and professors siteLink 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.
MONICA M MENDES, MD MSc principal investigator
UCPEL-UNIVERSIDADE CATÓLICA DE PELOTAS
ACHILLES GENTILINI NETO, MD study chair
INDEPENDENT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PIOLIN® and NEDAX in people with PEDICULOSIS, run by Phytopharm Consulting Brazil at 1 site in Brazil.
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 9 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 23 Oct 2013. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KARLA F DEUD JOSÉ, PharmD PhD (55 51 9279-3075, karla@phytopharm.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFICACY (time frame: 17 DAYS). 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 23 Oct 2013.